Neonatal Skin Care Study (NSCS)

Study Purpose
The purpose of the Neonatal Skin Care Study (NSCS) was to evaluate the effect of prophylactic application of Aquaphor^® Original emollient ointment during the first two weeks of life on the incidence of mortality and/or nosocomial bacterial sepsis at 28 days of age in infants of birth weight 501 - 1000 grams compared to those infants receiving routine skin care.

Study Design
Multicenter randomized clinical trial in 53 neonatal intensive care units of the Vermont Oxford Network.

Synopsis of the Study
The NSCS Study enrolled 1,206 extremely low birth weight infants 501 to 1000 grams to two study groups: the prophylactic Aquaphor group or the routine skin care group. Treated infants received two weeks of prophylactic Aquaphor application twice daily. Prophylactic Aquaphor ointment did not lead to a difference in death and or nosocomial bacterial sepsis in the first 28 days of life. Nosocomial bacterial sepsis was more frequent in the prophylactic group, with the difference predominantly in the lower weight stratum (501-750 grams) and when coagulase negative staphylococcus was the causal organism.

Status
Completed and Published.

Citation
Edwards WH, Conner JM, Soll RF for the Vermont Oxford Network Neonatal Skin Care Study Group. The Effect of Prophylactic Ointment Therapy on Nosocomial Sepsis Rates and Skin Integrity in Infants with Birth Weights of 501 to 1000 g. Pediatrics 2004;113:1195-1203.

Primary Investigators
William H. Edwards, MD, Dartmouth Medical School, Department of Pediatrics
Jeanette M. Conner MS, PhD, Vermont Oxford Network
Roger F. Soll, MD, University  of Vermont College of Medicine

Steering Committee
Jeffrey Gerdes, MD, Pennsylvania Hospital
Steven Hoath, MS, RCP, Skin Sciences Institute
Patrick Lewallen, MD, Emmanual Children's Hospital
Dennis Mujse, MD, Milton S. Hershey Medical Center
Judy Ohlinger, RN, Children's Hospital Medical Center of Akron

Study Sponsors
Our thanks to our sponsors: Beiersdorf Inc.