Thousands of babies per year die or develop Bronchopulmonary Dysplasia (BPD) in the US. BPD is a costly chronic childhood illness, and costs in total $17,481,047 annually. Survivors with BPD often suffer serious pulmonary and/or neurodevelopmental sequelae. While extremely-low birth-weight (<1000 g at birth) infants are at high risk of death or BPD, the most vulnerable are those born between 23 and 26 weeks' gestational age (GA). In this population, the rate of death or BPD was 68% in the recent 'SUPPORT' trial. There has been little improvement in incidence or severity of the disease. Novel interventions are urgently needed. We investigate two strategies to assist the transition from a fluid-filled in-utero lung to an air-filled lung after birth, in the first vital few minutesof life. Investigators and Prior Work: This prospective multi-national randomized Phase III trial, is led by an experienced, international productive team of trialists. They are collectively expert in ventilation or delivery room resuscitation or both. All PIs and co-Is have participated in or led multicenter or multi-national studies including PINT, TIPP, CAP, NIPPV, COIN and SUPPORT. Collectively, the leaders of this trial have established normative values of oxygenation in the delivery room; evaluated the use of a Sustained Inflation (SI) in the DR to establish breathing in the newborn; have demonstrated the use of non-invasive means of support in the delivery room as safe; tested a variety of lung interventions; and evaluated blood transfusion in the NICU. Approach: We will perform a RCT in preterm infants to determine which of two strategies at birth are best to optimally arate the lung. Specifically we will determine in 600 infants of 23-26 weeks GA needing respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the DR, as compared to early lung recruitment using SI in the DR, will result in a lower rate of the combined endpoint of death or BPD (using a standardized oxygen reduction test) at 36 weeks PMA? We will also compare which has the lower rate of other important secondary outcomes including rates of neurodevelopmental impairment at 18- 24 months of corrected age in survivors. The answers to these questions are highly relevant to the mission of the NICHD. Trial results will impact ILCOR and NRP guidelines. Environment: The combined clinical and data coordinating site at University Pennsylvania has a track record in the conduct of large international trials. We have partnered with a total of ten very influentia and recognized site investigators world-wide. We believe this trial is feasible within these sites, all of which have successfully completed many previous influential clinical trials in preterm infants. These trials have often changed clinical practice.
Prematurity is a major health care problem for America, where in an average week in the United States, 10,056 babies are born preterm, resulting in an economic cost to society of preterm birth in 2005 was more than $26.2 billion. Furthermore, of survivors less than 1000 g BW, about a half of the survivors will have severe handicaps. This study tries to find which of two therapies at birth is the best way to help these infants open thei lungs to start their life outside of the womb.
|Foglia, Elizabeth E; Owen, Louise S; Thio, Marta et al. (2015) Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. Trials 16:95|