NCT04295564

Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function

Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cynthia McEvoy · Academic / Other
• Sex: All
• Age: 1 Day – 12 Weeks
• Healthy volunteers: Not accepted

Summary

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.

Detailed description

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing. CPAP is a treatment widely used in the NICU in preterm infants right after they are born to help keep their lungs open/inflated. Although the benefit of CPAP after birth has been well studied, no one knows how long a stable preterm infant should stay on CPAP. The primary outcome of this study is to compare the lung volumes in the infants at 6 months of age by pulmonary function testing who were randomized to 2 extra weeks of CPAP in the NICU versus CPAP discontinuation, usual care. During the same pulmonary function test the investigators will also measure and compare how the infant's lungs diffuse gas.

Conditions

• Neonatal
• Premature Birth
• Respiratory Distress Syndrome

Interventions

Type	Name	Description
OTHER	Additional 2 weeks of CPAP	Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.

Timeline

• Start date: 2020-01-10
• Primary completion: 2023-09-18
• Completion: 2024-03-15
• First posted: 2020-03-04
• Last updated: 2025-08-17
• Results posted: 2025-08-17

Locations

1 site across 1 country: United States