The National Institute of Child Health and Development (NICHD) has launched a clinical research trial to evaluate 2 different ways to help premature babies breathe right after birth.
The SAIL study is a prospective randomized controlled unblinded trial in preterm infants to determine which of two strategies at birth are best to optimally aerate the lung. The study will determine which of two lung opening strategies will result in a lower rate of bronchopulmonary dysplasia (BPD) at 36 weeks gestational age. This trial is called the SAIL trial and will be conducted in 600 preterm infants across 14 sites in the USA, Canada, Italy, Germany, Netherlands and Australia.
Why is The SAIL Trial being Conducted?
The SAIL study is being done to evaluate the impact of Sustained Inflation (SI) versus the current standard accepted Newborn Resuscitation Program (NRP) in the delivery room on the need for mechanical ventilation in the first week of life. This trial will examine which of the 2 respiratory methods results in a lower rate of the combined endpoint of death or BPD (using a standardized oxygen reduction test) at 36 weeks Post Menstrual Age.
What Will Happen in The SAIL Trial?
Infants who are born in participating Neonatal Intensive Care Units (NICUs) with a gestational age of at least 23 weeks but less than 27 weeks and who require respiratory intervention at birth will be eligible to participate in the study. Eligible babies will be randomized to either one of the study groups: (1) NRP guidelines using positive pressure ventilation (PPV) or (2) sustained inflation maneuver. Routine medical record information about each baby’s health and respiratory status during hospitalization will be collected. Information from comprehensive medical assessments done at the 22-26 month follow-up medical appointment will also be included.