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

Phase 2

Active, not recruiting

• Conditions: Neonatal; Premature Birth; Respiratory Distress Syndrome
• Interventions: Other: Additional 2 weeks of CPAP

• 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
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Arm && Interventions

Group	Intervention	Description
eCPAP	Additional 2 weeks of CPAP	Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met.

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.

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Flows	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.
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.

Trial Locations

Locations (1)

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