Sustained Aeration of Infant Lungs / SAIL

Background

At birth, infants’ lungs are filled with fluid, which must be cleared for effective breathing to occur. Typically healthy term infants are able to clear this fluid by taking deep breaths after birth. If a baby is breathing but needs a little extra support, then he or she may receive continuous positive airway pressure (CPAP) through a mask. The mask is secured around the baby's mouth and nose and mechanical breaths are delivered at 40-60 breaths per minute. Giving a long initial breath or sustained inflation (SI) may help clear the fluid in the lungs and allow the baby to breathe effectively sooner. No study has carefully looked at the physiologic changes that occur with giving a long initial breath in premature infants. The trial is being conducted in 13 sites in the United States, Canada, Germany, Italy, the Netherlands, and Australia. The trial is funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). 

You can read more about Sustained inflation trial at sailtrial.org or clinicaltrials.gov

Purpose

The purpose of this study is to determine which of two lung opening strategies – either a standard CPAP in the delivery room or an early lung recruitment using SI in the delivery room - results in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (using a standardized oxygen reduction test) at 36 weeks Post Menstrual Age (PMA). This study will include 600 infants internationally, approximately 60 of whom will be enrolled at Sharp Mary Birch. 

Who to contact if you want more information

You may also contact the Sharp Mary Birch Neonatal Intensive Care Unit (NICU) at: 858 939-4298, or NICU Research Offices at:  858 939-4112

The Research Team will be contacting you regarding your interest in this study.