If a mother obtains late prenatal care, and has unsure dates, how would you like us to determine dates? Do we use the Ballard exam?
Since babies are randomized prior to delivery, the OB’s best estimate of gestational age will determine eligibility and stratification. Postnatally, Ballard exam and clinical judgment should be used to assess the best assessment of gestational age. There will be some babies who will appear to be a different gestational age after birth than the gestational age assessed prior to birth. Regardless, of any discrepancy the infant will remain in the gestational age strata assigned prior to birth during the randomization process.
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As outcomes will be assessed based upon intent to treat, how might violations of protocol be taken into account (i.e. refusal of an attending physician to intubate for surfactant in a vigorous 28 5/7 week infant so randomized?
We will track all protocol violations and they will be accounted for in the data analysis. During the conduct of the study, we will collect detailed information about the circumstances surrounding the protocol violation.
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If you are in the act of administering surfactant (i.e. started it but not finished yet) and you cross the 15-minute window, is that a failure of protocol?
No. The goal is to begin administration of the assigned intervention within 5-15 minutes of life.
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How are you going to handle room saturations for high-altitude centers (when measuring saturations to determine primary outcome measure)?
The saturation test obtained for determining the primary outcome measure-requirement for oxygen at 36 weeks adjusted age will not vary among centers. Centers located at high altitude will follow the same parameters for testing oxygen requirement as all other centers.
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You define CLD as O2 or respiratory support at 36 weeks adjusted age. How can we compare results with other BPD studies most of which have defined BPD as O2 requirement at 28 days of life?
We will be collecting data on need for respiratory support at day 28, 36 weeks adjusted age, and 40 weeks adjusted age. These outcome measures are comparable with the defined outcome measures of many published studies on infants with CLD.
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Are we randomizing multiple births as a set or individually?
Multiple births are to be randomized as individuals. If parents are concerned about this, then randomize the first born infant and treat the other(s) accordingly.
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If you randomize a woman/infant shortly before delivery and the randomization envelope is opened, but then the woman does not deliver for awhile, do you keep the same randomization assignment for that dyad?
Yes. Also, we strongly suggest that the randomization envelope not be opened until there is clear indication that the mother is delivering imminently.
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Is randomization the same across all gestational ages? Are infants at 26 weeks gestation treated the same as 29 6/7 weeks?
Infants will be stratified by gestational age category: Strata One 26 +0 – 27+6 weeks and Strata Two 28+0 – 29+6 weeks. So depending on estimated gestational age at delivery, an infant will be randomized into either of these two strata.
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If I have already submitted the protocol and consent form, must I submit them again with the updated protocol version 3.0?
Version 3.0 is the most current protocol and consent version and should be submitted with their introductory letter to your IRB. If you have not given these materials to your IRB, then please submit them to your IRB
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If we are moving from a flow driver to a bubble CPAP system, how do we ‘consent’ parents for this ‘new’ therapy since we aren’t in the research portion of the RCT?
Bubble CPAP is not a new or experimental therapy, albeit a new therapy for your unit. Parental consent is not necessary for a change in therapy. Certainly parental notification is appropriate.
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Is there a sheet that highlights the changes to protocol version 3.0?
Yes, this is available upon request and can be given to your IRB.
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If you are in the act of administering surfactant (i.e. started it but not finished yet) and you cross the 15-minute window, is that a failure of protocol?
No. The goal is to begin administration of the assigned intervention within 5-15 minutes of life.
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Reintubation: In the criteria for re-intubation, do you have to intubate if the PCO2 is > 65? What about an oxygen requirement of > 40-60%? Is the infant supposed to be reintubated for one or all of these criteria?
The criteria for reintubation are guidelines that require clinical judgment along with the defined clinical indicators. An infant does not have to be reintubated if he/she meets only one criterion and the clinician believes that reintubation is not indicated. Howeve, the infant meets more than one of the defined clinical criteria, then the infant should be intubated.
If the infant has an oxygen requirement of 40%, we recommend reintubation to administer surfactant. If the infant requires 60% oxygen then the infant must be reintubated and given surfactant. This is so that we do not deny a proven therapy (surfactant administration) to an infant who would clearly benefit from it.
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Surfactant: Do we need to use a specific brand of surfactant?
No, just a natural (animal derived) surfactant product.
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Timing of Treatment: How critical is the use of immediate use of NCPAP in the delivery room and what is the maximum or minimum amount of time we have before initiating the NCPAP in the delivery room?
The protocol requires that NCPAP be initiated as the mode of stabilization within 5-15 minutes of age.
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Timing of Treatment: If you are in the act of administering surfactant (i.e., started it but not finished yet) and you cross the 15-minute window, is that a failure of protocol?
No. The goal is to begin administration of the assigned intervention within 5-15 minutes of life.
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Treatment Groups: In the ISX group (intubation, prophylactic surfactant, and rapid extubation to CPAP), were did the “..less than 60% O2 at 15-30 minutes after treatment..” come from?
It was a Steering Committee decision. The Committee felt that if the infant required more than 60% of oxygen after surfactant administration then most clinicians would not be willing to extubate the infant.
The decision is consistent with the "re-intubation" criteria that suggest reintubations for infants > 60% oxygen.
Some clinicians may not feel comfortable extubating an infant who requires 40- 60% oxygen after surfactant administration but we would like the infant to be extubated to CPAP if the infant is not experiencing significant respiratory distress.
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Treatment Groups: The protocol mentions the need for fractional O2 in the delivery room for the Prophylactic Surfactant Group (PS Group) and the Intubation, Prophylactic Surfactant, and Rapid Extubation Group (ISX Group). We usually do not use Spo2 monitor in the DR. how crucial is this requirement?
Though recommended, it is not critical to meet this requirement for stabilization during delivery.
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Gastric Distention: Why do some babies experience so much GI air distention while on NCPAP even when an OG tube is placed to vent the stomach? Is there some other technique that we can use to deal with this, so babies can be fed?
Gastric distension is caused by the infant swallowing air. The pressure of CPAP is 5 cm H20, the intragastric pressure is > 10 cm H20. The infant has to swallow air to cause distention. This may be more of a problem in some infants more than others and may be addressed according to the needs of individual infants. Insert an OG tube and aspirate frequently. If the OG tube is not effectively venting the stomach it is may be because it is occluded or too narrow in diameter. Be sure to use an 8 Fr catheter or larger. We recommend that you vent the stomach every 3 hours, especially after feeds. If the infant is NPO continuous venting may help. Try placing the infant prone. Mild CPAP gastric distention has not been associated with an increased incidence of NEC or perforation and it is not necessary to discontinue bolus feeds.
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Nare Blanching: In the "Trouble Shooting" section of the Study Binder, there is mention of persistent blanching of the nose. Is some blanching of the nose with the initial set up of the Hudson prongs acceptable until the nares dilate? If so, for how many hours is the blanching acceptable?
Blanching occurs for two reasons: 1) the prongs are too large, or 2) the prongs are incorrectly positioned. After applying the prongs and attaching the corrugated tubing spend some time adjusting the angle at the corners to curve the prongs slightly to match the curved plane across the top lip. If you find that blanching continues despite correct positioning then you will probably need to use smaller prongs. If already using size zero prongs in a very small baby you may need to gently dilate the nares prior to prong placement. Place one prong in one nare to dilate it slightly. Repeat for the other nare, and then try to insert both prongs. You may find initially that you are not able to insert the prongs in as deeply as you would for a larger infant. The nares will dilate to accommodate the prongs over the next hour or so. Excessive blanching may injure the skin and the internal structures within the nose so careful observation and positioning is essential
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Nasal Septal Injury: Do you have much problem with bleeding in the nares from frequent suctioning?
Bleeding from the nares is usually a result of technique rather than frequency. Keep in mind that the nasal passage actually follows a downward curve almost immediately beyond the opening at the nares so it is wise to enter at an almost right angle to the plane of the face. Use a few saline drops pre suctioning to moisten the area and provide a little lubrication. When introducing the catheter to the nares gently glide it in one smooth motion rather than several repeated entries. Be sure to use adequate humidification as a healthy mucosa tolerates suctioning better than one that is dry or congested.
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Nasal Septal Injury: Several of our babies who go on bubble CPAP end up with ‘pig noses’. This is a major concern and source of dislike to several staff members. Is there a way to prevent that or how would you approach that concern?
The ‘pig nose’ is mostly associated with the flow driver prongs, as they need to press up against the nose to provide an adequate seal. The Hudson prongs are designed to provide an adequate seal without being pushed up right against the septum and should not produce ‘pig hose’ if positioned correctly. There is some dilation of the nare, but this is not a permanent problem once CPAP is discontinued.
Nasal septal damage is absolutely preventable when meticulous attention is paid to avoiding pressure on the columella and septum. There should always be a cushion of air (2-3mm) between the bridge of the prongs and the septum. The prongs must fit snuggly and be well secured using the hat and a Velcro moustache. In the Education and Training Manual you will find instructions about the prong placement and prevention of nasal septal damage (pgs. 14, 18-20). Following these instructions, along with frequent observations, will prevent septal injury.
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Nasal Septal Injury: What do I do if there is redness of the nasal septum from the prongs?
If there is redness or grazing it is due to inadvertent pressure. The cannula must be off of the nasal septum at all times. Use velcro below the cannula. Nasal erosion or necrosis will not occur if the cannual does not compress the septum. For an area that is red, just reposition the prongs off the septum and allow the area to recover.
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I believe the success of this study is dependent upon a unit's belief that bubble nasal CPAP is an effective treatment option, but requires a sense of equipoise regarding the initial management issues. How does one go about preventing various groups involved in patient care from sabotaging the study?
This is a very important issue. Members of the health care team from each unit contemplating participation in this study need to make sure they can maintain equipoise and live with following the protocol for babies assigned to any of the treatment arms. Equipoise doesn't mean that you have no opinion - it just means that you can accept the fact that there is not a clearly defined firm answer as to which approach is the best; and that you believe it is ethical to randomly allocate babies to each of the study arms. If a significant number of staff, including those in leadership roles, cannot live with random allocation, then it would be best if the center did not participate.
One of the purposes of the pilot study was to give Centers an opportunity to carry out this protocol. The pilot study provided a framework for learning about the feasibility of the study overall and within each participating center.
One of the purposes of the pilot study is to give Centers an opportunity to carry out this protocol. The pilot study provides a framework for learning about the feasibility of the study overall and within each participating center.
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Delivery Systems: Are there any studies comparing flow generator CPAP to bubble CPAP?
Yes, there is one study however it compares flow drivers to single-prong cpap delivery. Citation: " A randomized controlled study comparing the infant flow driver with nasal continuous positive airway pressure in preterm infants. M Mazella, C Bellini et al. Arch. Dis Child Fetal Neonatal Ed. 2001, 85, F86-F90.
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Nasal Prongs: How does the resistance of the Inca prongs compare to the Hudson prongs?
The relative resistances of these prongs have not been directly measured and compared in the published literature. We do know from laws of physics that resistance increases proportionately with increasing length of the prongs and exponentially with decreasing radius. Therefore, the longer and narrower the prongs, the higher the resistance will be. Since Hudson and Inca prongs are somewhat similar in design, similar sized prongs of either type are likely to have similar resistance (this means actual measured size, not any nominal size category of the manufacturers). As it is recommended that the largest size prong that will fit snugly in the nares without causing persistent blanching of the skin be used, the resistance should not be very different if sticking to this guideline. Note that the smallest Inca prongs are smaller than the smallest Hudson prongs, so if the former are used (either as a general preference or due to a perceived need to use a smaller prong size than the smallest available Hudson prongs in a particular infant), there will be a higher resistance with less efficient delivery of the generated CPAP to the patient airway. Also, in contrast to the straight Inca prongs, the Hudson prongs are curved, in theory to accommodate the normal anatomy of the proximal nasal airway and direct the generated pressure appropriately down this airway.
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Pressure/Bubbling: Is intermittent bubbling acceptable and for how long?
Consistent bubbling is important to recruit alveoli, maintain functional residual capacity (FRC), and reduce airway resistance and work of breathing, especially in the early acute phase of respiratory distress. If the bubbling stops it means that there is a pressure leak somewhere. CPAP is not a closed leak proof system. The baby cries or yawns and pressure will leak. The most common site for leak is the mouth. We recommend a chin strap to keep the mouth closed at rest. It should not be so tight as to prevent the infant from yawning or crying, but tight enough to prevent leak at rest.
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Pressure/Flow : We are supposed to initially place the infant at 5 cm H2O of CPAP; does it need to stay at that level regardless of the infant’s condition?
Yes. The CPAP pressure should remain at 5. We do not suggest that the pressure ever be weaned, as if to wean the infant off CPAP. We will permit though; a ‘last ditch’ effort to increase the pressure to 7 should an infant experience respiratory failure that does not improve after following the “Checklist for Evaluating the CPAP Delivery System During Respiratory Failure”, pg 27 of your CPAP Education and Training Manual.
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Pressure/Flow: How would you increase the CPAP to 7 cm H2O? By increasing flow?
You lower the circuit tube in the water bottle to 7 cm H2O. If using the Airways canister bottle, add water to the 7 cm H2O level.
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Pressure/Flow: What criteria are used to adjust the flow delivery between 5-10 liters/minute?
A flow of less than 5 lpm is not sufficient to blow off CO2 in the circuit. If you need more than 10 lpm to produce consistent bubbling then this indicates that a pressure leak exists and every effort should be made to minimize the leak. Turning up the flow to compensate for leaks actually increases resistance and is not advised. In the clinical setting adequate CPAP pressure is generated with a flow between 6 and 8 lpm.
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Pressure: Why aren’t we starting with 6 cm H2O pressure?
Based on two issues, 1) Cochrane review supports 5 cm H2O or greater as an effective limit, and 2) this pressure conforms to routine practice at some of the most experienced Centers (i.e. Columbia).
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Circuit Tubing /Humidity: We are having problems with excessive rain-out in the circuit tubing causing blockage and we have not found a solution. What can we do?
The short answer is that some rain out is inevitable as a consequence of the temperature inside the tubing being higher than ambient room temperature. We find that the rain-out varies with the fluctuations in the environmental temperature (drafts etc.). The cooler the room the more heat will be lost and the more water vapor will rain-out. Even well humidified gas will cool over the length of the tubing. The heat source within the infant’s environment, either incubator or radiant warmer has some effect as well. We tend to just check it regularly and drain it as needed.
If you are using the Fisher and Paykel humidifiers there are some techniques with manipulating the main temp and the chamber temperature that work quite well at compensating for heat loss, reducing rain-out and maximizing the mg/L of humidity the infant receives. We suggest you contact your F&P product representative regarding these manipulations. Their company has done some interesting lab and clinical research on humidification.
If you set the chamber temperature at –1 or –2 degrees the gas leaving the chamber will be 1 or 2 degrees lower than the temperature set on the main dial but will warm up 1 or 2 degrees on it’s way through the circuit compensating somewhat for the heat loss through the wall of the tubing. Try placing the temperature probe just outside the incubator if the incubator temp is 34 degrees C or greater. Or place it inside but away from the incubator heated air flow if the incubator temp is low (32 degrees). If using a radiant warmer, again try keeping the circuit temp probe away from the heat source or if that is not possible, shield it with a reflector if possible.
At Columbia, the temperature is routinely set at 36.8 to 37.2 degrees C and the chamber temp is set at 0. In addition to these settings, a very vigorous suctioning protocol (every 3 hrs) is followed. Because rain-out affects the gas flow and resistance, it is checked and drained regularly.
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Circuit Tubing: How often does the circuit have to be changed?
There is no strict guideline for circuit change in the study. Follow your usual protocol (if available) for changing circuits. We usually change our circuits every week
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General Equipment: Where do we get the equipment to make the bubble CPAP systems?
Refer to the back of your NCPAP Education and Training Manual (pg. 36) for a list of the items, product numbers, and their manufacturers.
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Hats: What type of hats do you suggest we use? We don’t use the hats provided with the Hudson prongs because they’re one size fit all, and most of the time they don’t fit most of our babies’ heads.
The hat must fit snuggly, as it is the anchor for the prongs. The Hudson hats come in different sizes according to the prong size in the package. They usually fit for the first 24 hours but are known to stretch out of shape quickly. This is because they are made of a knit fabric without any elastic/lycra type blend. If you are having success with the Inca or Aladdin hats, then I suggest continuing with them as long as the cost is not prohibitive. At Columbia Presbyterian in NYC they have found that using the Stockinette and custom making a hat for the infant is successful and cost effective.
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How often does the CPAP bottle and water need to be changed?
If using acetic acid solution, change the bottle and solution every week. If using sterile water, change the bottle and water every 72 hours.
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Nasal Prongs: Can we use EME prongs and flow drivers?
No, infants randomized to receive CPAP need to be placed on a bubble bottle CPAP system.
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Nasal Prongs: How does the resistance of the Inca prongs compare to the Hudson prongs?
The relative resistances of these prongs have not been directly measured and compared in the published literature. We do know from laws of physics that resistance increases proportionately with increasing length of the prongs and exponentially with decreasing radius. Therefore, the longer and narrower the prongs, the higher the resistance will be. Since Hudson and Inca prongs are somewhat similar in design, similar sized prongs of either type are likely to have similar resistance (this means actual measured size, not any nominal size category of the manufacturers). As it is recommended that the largest size prong that will fit snugly in the nares without causing persistent blanching of the skin be used, the resistance should not be very different if sticking to this guideline. Note that the smallest Inca prongs are smaller than the smallest Hudson prongs, so if the former are used (either as a general preference or due to a perceived need to use a smaller prong size than the smallest available Hudson prongs in a particular infant), there will be a higher resistance with less efficient delivery of the generated CPAP to the patient airway. Also, in contrast to the straight Inca prongs, the Hudson prongs are curved, in theory to accommodate the normal anatomy of the proximal nasal airway and direct the generated pressure appropriately down this airway.
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Nasal Prongs: It sounds like the Fisher and Paykel prongs are evolving. They look great fundamentally. Are we able to use these for the study?
We really have limited experience with them and therefore we currently do not recommend using them.
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Nasal Prongs: We currently use the "INCA" prongs, which are short binasal prongs; is this OK, or do we have to switch to the Hudson?
Inca prongs are OK, but not ideal. The difference between Inca and Hudson is that the Hudson prongs are anatomically curved and when placed on the the upper lip the prongs will point to the nasal cavity. The Inca prongs are smaller and are not curved, they do not point into the nasal cavity and therefore can cause obstruction. You will not get as good of a seal or CPAP delivery with the Inca prongs. Smaller prongs are not necessarily beneficial to the infant. Smaller prongs will be more mobile and may lead to discomfort and/or septal injury. The narrower the prongs the greater the resistance and the less effective the CPAP therapy will be. If you have good success with Inca prongs and can deliver effective bubble CPAP without nasal injury or leak, then you will not need to switch. However, our primary choice for nasal prongs is the Hudson prongs.
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Nasal Prongs: We use Inca prongs size 00 for the very tiny noses of babies at various weeks gestational age. These are the only prongs that we are able to fit in their noses for the first 3 to 4 days. Is the use of Inca prongs for small noses acceptable?
At Columbia Children’s Hospital they have found that the size 0 Hudson prongs will fit the tiniest of infants (390 g is the smallest on Hudson so far). The Hudson prongs are curved to fit the nares anatomically and we have never needed to use another brand due to small nares. Our primary choice for nasal prongs in the trial is Hudson prongs. If you can deliver effective bubble CPAP without nasal injury or leak, then you can use them.
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Gastric Distention: Why do some babies experience so much GI air distention while on NCPAP even when an OG tube is placed to vent the stomach? Is there some other technique that we can use to deal with this, so babies can be fed?
Gastric distension is caused by the infant swallowing air. The pressure of CPAP is 5 cm H20, the intragastric pressure is > 10 cm H20. The infant has to swallow air to cause distention. This may be more of a problem in some infants more than others and may be addressed according to the needs of individual infants. Insert an OG tube and aspirate frequently. If the OG tube is not effectively venting the stomach it is may be because it is occluded or too narrow in diameter. Be sure to use an 8 Fr catheter or larger. We recommend that you vent the stomach every 3 hours, especially after feeds. If the infant is NPO continuous venting may help. Try placing the infant prone. Mild CPAP gastric distention has not been associated with an increased incidence of NEC or perforation and it is not necessary to discontinue bolus feeds.
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Hats: What type of hats do you suggest we use? We don’t use the hats provided with the Hudson prongs because they’re one size fit all, and most of the time they don’t fit most of our babies’ heads.
The hat must fit snuggly, as it is the anchor for the prongs. The Hudson hats come in different sizes according to the prong size in the package. They usually fit for the first 24 hours but are known to stretch out of shape quickly. This is because they are made of a knit fabric without any elastic/lycra type blend. If you are having success with the Inca or Aladdin hats, then I suggest continuing with them as long as the cost is not prohibitive. At Columbia Presbyterian in NYC they have found that using the Stockinette and custom making a hat for the infant is successful and cost effective.
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Nare Blanching: In the "Trouble Shooting" section of the Study Binder, there is mention of persistent blanching of the nose. Is some blanching of the nose with the initial set up of the Hudson prongs acceptable until the nares dilate? If so, for how many hours is the blanching acceptable?
Blanching occurs for two reasons: 1) the prongs are too large, or 2) the prongs are incorrectly positioned. After applying the prongs and attaching the corrugated tubing spend some time adjusting the angle at the corners to curve the prongs slightly to match the curved plane across the top lip. If you find that blanching continues despite correct positioning then you will probably need to use smaller prongs. If already using size zero prongs in a very small baby you may need to gently dilate the nares prior to prong placement. Place one prong in one nare to dilate it slightly. Repeat for the other nare, and then try to insert both prongs. You may find initially that you are not able to insert the prongs in as deeply as you would for a larger infant. The nares will dilate to accommodate the prongs over the next hour or so. Excessive blanching may injure the skin and the internal structures within the nose so careful observation and positioning is essential
return to top
Nasal Prongs: Can we use EME prongs and flow drivers?
No, infants randomized to receive CPAP need to be placed on a bubble bottle CPAP system.
return to top
Nasal Prongs: It sounds like the Fisher and Paykel prongs are evolving. They look great fundamentally. Are we able to use these for the study?
We really have limited experience with them and therefore we currently do not recommend using them.
return to top
Nasal Prongs: We currently use the "INCA" prongs, which are short binasal prongs; is this OK, or do we have to switch to the Hudson?
Inca prongs are OK, but not ideal. The difference between Inca and Hudson is that the Hudson prongs are anatomically curved and when placed on the the upper lip the prongs will point to the nasal cavity. The Inca prongs are smaller and are not curved, they do not point into the nasal cavity and therefore can cause obstruction. You will not get as good of a seal or CPAP delivery with the Inca prongs. Smaller prongs are not necessarily beneficial to the infant. Smaller prongs will be more mobile and may lead to discomfort and/or septal injury. The narrower the prongs the greater the resistance and the less effective the CPAP therapy will be. If you have good success with Inca prongs and can deliver effective bubble CPAP without nasal injury or leak, then you will not need to switch. However, our primary choice for nasal prongs is the Hudson prongs.
return to top
Nasal Prongs: We use Inca prongs size 00 for the very tiny noses of babies at various weeks gestational age. These are the only prongs that we are able to fit in their noses for the first 3 to 4 days. Is the use of Inca prongs for small noses acceptable?
At Columbia Children’s Hospital they have found that the size 0 Hudson prongs will fit the tiniest of infants (390 g is the smallest on Hudson so far). The Hudson prongs are curved to fit the nares anatomically and we have never needed to use another brand due to small nares. Our primary choice for nasal prongs in the trial is Hudson prongs. If you can deliver effective bubble CPAP without nasal injury or leak, then you can use them.
return to top
Nasal Septal Injury: Do you have much problem with bleeding in the nares from frequent suctioning?
Bleeding from the nares is usually a result of technique rather than frequency. Keep in mind that the nasal passage actually follows a downward curve almost immediately beyond the opening at the nares so it is wise to enter at an almost right angle to the plane of the face. Use a few saline drops pre suctioning to moisten the area and provide a little lubrication. When introducing the catheter to the nares gently glide it in one smooth motion rather than several repeated entries. Be sure to use adequate humidification as a healthy mucosa tolerates suctioning better than one that is dry or congested.
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Nasal Septal Injury: Several of our babies who go on bubble CPAP end up with ‘pig noses’. This is a major concern and source of dislike to several staff members. Is there a way to prevent that or how would you approach that concern?
The ‘pig nose’ is mostly associated with the flow driver prongs, as they need to press up against the nose to provide an adequate seal. The Hudson prongs are designed to provide an adequate seal without being pushed up right against the septum and should not produce ‘pig hose’ if positioned correctly. There is some dilation of the nare, but this is not a permanent problem once CPAP is discontinued.
Nasal septal damage is absolutely preventable when meticulous attention is paid to avoiding pressure on the columella and septum. There should always be a cushion of air (2-3mm) between the bridge of the prongs and the septum. The prongs must fit snuggly and be well secured using the hat and a Velcro moustache. In the Education and Training Manual you will find instructions about the prong placement and prevention of nasal septal damage (pgs. 14, 18-20). Following these instructions, along with frequent observations, will prevent septal injury.
return to top
Nasal Septal Injury: What do I do if there is redness of the nasal septum from the prongs?
If there is redness or grazing it is due to inadvertent pressure. The cannula must be off of the nasal septum at all times. Use velcro below the cannula. Nasal erosion or necrosis will not occur if the cannual does not compress the septum. For an area that is red, just reposition the prongs off the septum and allow the area to recover.
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Skin Integrity/Mustache: In using the mustache, do you ever find breakdown on the lip? How often is the mustache removed to check skin integrity?
We have not experienced any breakdown on the lip with the mustache placement. The Velcro is placed over Tegaderm so there is little problem with it causing skin breakdown. We don’t recommend that you lift it up to evaluate the skin underneath. The area around the upper lip tends to become damp as a result of secretions, saline, and the immaturity of the skin. In our experience we have found that the mustache usually needs replacing once a day. Due to this frequent changing and the nature of the Tegaderm adhesive we haven’t had a problem with skin breakdown on the upper lip.
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Suctioning: Do you recommend suctioning on a regular schedule for babies on nasal CPAP, or only as-needed?
We recommend that you suction at least every 2-3 hr in the first few days of life. If an infant is exhibiting some signs of increased work of breathing or distress, then the infant may require more frequent suctioning, such as every 1-2 hr. Refer to your Education and Training Manual, pg. 17-19 for details on suctioning.
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Suctioning: We are having trouble with bloody secretions. Can you describe the suctioning technique and how we can prevent injury during suctioning?
The bloody secretions may be from a dry airway and the suctioning technique.
A dry mucusa will be more easily injured during suctioning . As you know the role of the nasal mucosal is to deposit moisture into the airway so that the cold inspired gas is humidified before it enters the rest of the respiratory system. If we place an object (such as the nasal prongs ) into the nose or if there is inadequate humidification in the inhaled gas, the mucosa tries to compensate and becomes congested and edematous. Any friction or irritation to the cells will lead to bleeding and
further loss of mucosal integrity.
It is recommended that the humidification within the circuit is as close to or equal to 100%. This can be achieved by adjusting the humidifier chamber and tubing temperature to ensure that the air is continually heated as it passes through the circuit.
The issue of technique is a little more difficult to resolve. Here are some
key points:
- Try to limit the number of catheter insertions per each suction session.
Use the largest size suction catheter that can be passed into the nares
without resistance. This is usually an 8 Fr. Size 6 Fr may slide in more
easily but they are less effective at removing secretions and will require
more frequent passing (i.e. you can yield as much with one passage of a size 8 as you can with 2 or 3 passages of a size 6.).
- Use saline drops to moisten the nares and provide a little lubrication.
- Effective secretion removal must include the naso/oro pharynx. Measure the distance between the pinna and the nares and add half that distance again. This will ensure adequate suction depth.
- When inserting the tip of the catheter keep in mind the internal anatomy
of the nose. The nasal airway very quickly curves down toward to naso
pharynx so the tip of the catheter should be pointing towards the lower part of the pinna of the ear.
- Don't just suction the nose and avoid rapid, short catheter insertions.
Pass the catheter to the required suction depth, apply suction for 2
seconds, rotate the catheter 360' , slowly remove it for a count of 3 -4
seconds continuing to rotate it until it is out of the nose. This slow
continuous suction is more effective and less irritating than frequent short
passing.
NICUs that practice this q3 hourly suction routine rarely see bloody nasal secretions.
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We are a new center joining the trial. Is there material available to help us quickly get up to speed?
Yes. Materials will be forwarded to all centers interested in joining and are available on the website. Please contact Karla Ferrelli at karla@vtoxford.org, if you are interested in joining the trial.
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Are the web conference presentations available as a file that could be forwarded to us?
Yes! All web conference presentations are recorded and will be made available to all participating Centers through our website. You must log in to the Education and Training web pages to get to these presentations. You can either download the presentations or view them from the site.
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How do I log in to the Education and Training web pages?
You must use the username and password provided to you in your Study Binder, Tab 4, pg 17.
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