Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two types of breathing support, called Nasal CPAP and NIPPV, affect the diaphragm's activity in very low birth weight (VLBW) preterm infants. Both methods help these tiny babies breathe better, especially when their lungs are still developing. CPAP provides a steady pressure to keep their lungs open, while NIPPV offers that same pressure but also gives extra breaths at intervals to help the baby breathe. Researchers want to find out if one method is more effective than the other in reducing the need for more intensive breathing support.

To participate in this trial, infants must be clinically stable, weigh less than 1500 grams, and have been on Nasal CPAP for at least 48 hours while needing less than 35% oxygen. Unfortunately, babies with certain health issues, like severe heart defects or significant brain injuries, cannot join. If eligible, participants will have a small feeding tube placed that will also measure how well their diaphragm is working while using either breathing support method. The trial is currently recruiting participants at the Sunnybrook Health Sciences Centre.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist)
• • Birth weight less than 1500 grams
• • Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen
• Exclusion Criteria:
• • Congenital anomalies of the gastrointestinal tract
• • Phrenic nerve damage
• • Diaphragmatic paralysis
• • Esophageal perforation
• • Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure
• • Significant congenital heart disease (including symptomatic PDA)
• • Congenital anomalies of the diaphragm
• • Congenital anomalies of the respiratory tracts (e.g., Congenital Cystic Adenomatoid Malformation 'CCAM')
• • Ongoing treatment for sepsis
• • Ongoing treatment for necrotizing enterocolitis (NEC)
• • Ongoing treatment for lung infections
• • Narcotic analgesics
• • Gastric motility agents
• • Infants on nasal CPAP and requiring more than 35% oxygen
• • Infants with significant gastric residuals and vomiting
• • Infants with facial anomalies
• • Infants with pneumothorax or pneumomediastinum
• • Infants in the immediate postoperative period