Lungs of babies born early are not fully developed and they often need a machine to help them breathe. The traditional approach to provide this support is with a breathing tube passed into the windpipe. However, we know that breathing tubes can cause injury to the fragile lungs of premature babies. Providing breathing support through nose-masks instead of breathing tubes (called nasal breathing support) is becoming popular, as it is gentler on developing lungs. Doctors, in trying to limit the use of support with a breathing tube, are using many different forms of nasal breathing support. The most common form is nasal continuous positive airway pressure (CPAP) which delivers a constant pressure and the baby breathes on his on her own. However, when this strategy is no longer able to support a premature baby's breathing, the best way to provide breathing support is not known. Some doctors use a strategy called "nasal intermittent positive airway pressure" (NIPPV) which gives the baby artificial breaths through the nose-mask. Others simply increase the pressure on nasal CPAP to higher than traditional levels. In the first study of its kind, we will compare these two strategies of nasal breathing support given to premature babies.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Ability to enroll a minimum of 10% of all eligible neonates per year at each site
Timeframe: Through study completion (total 42 months)
Fewer than 20% randomized subjects with protocol violations in High CPAP arm
Timeframe: Through study completion (total 42 months)
Fewer than 20% randomized subjects with protocol violations in NIPPV arm
Timeframe: Through study completion (total 42 months)
Fewer than 20% of enrolled (consented, but pre-randomization) subjects with protocol violations
Timeframe: Through study completion (total 42 months)