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

Not Applicable

Completed

• Conditions: Neonatal; Premature Birth; Respiratory Distress Syndrome

• Registration Number: NCT04295564
• Lead Sponsor: Cynthia McEvoy

Brief 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.

Study Timeline

• Study First Submitted: 2019-12-31
• Study Start: 2020-01-10
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Primary Completion: 2023-09-18
• Study Completion: 2024-03-15
• Results First Submitted: 2024-11-21
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Results First Posted: 2025-08-17
• Last Update Posted: 2025-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Infants born at >24 to ≤ 32 weeks gestation
2. Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation)

Exclusion Criteria

1. Significant congenital heart disease
2. Major malformations
3. Chromosomal anomalies
4. Culture proven sepsis at consent
5. Complex maternal medical conditions
6. Clinical instability
7. Multiple gestations > twins
8. <3rd or >97th percentile for weight85
9. Participating in another neonatal randomized clinical trial with a competing outcome
10. Mother/legal guardian without stable method of communication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alveolar Volume	4 - 8 months of age	Establish that 2 additional weeks of CPAP in the NICU for stable preterm infants changes alveolar volume at approximately 6 months of age compared to infants who have CPAP discontinued, usual care. Measurements of alveolar volume were obtained at the same time as measurements of lung diffusion using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Flows at 50% of the Expired Volume (FEF50)	4 - 8 months of age	Establish that 2 extra weeks of CPAP in stable preterm infants increases forced expiratory flows at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Forced expiratory flows were measured using the raised volume rapid thoracic compression technique following specific American Thoracic Society and European Respiratory Society criteria for acceptance.
Lung Diffusion	4 - 8 months of age	Establish that 2 extra weeks of CPAP in stable preterm infants increases lung diffusion at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Measurements of lung diffusion were obtained at the same time as measurements of alveolar volume using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.

Trial Locations

Locations (1)

Doernbecher Neonatal Care Center at Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States