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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal, Premature Birth, Respiratory Distress Syndrome

Intervention / Treatment
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* Other: Additional 2 weeks of CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born at >24 to ≤ 32 weeks gestation Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation) Exclusion Criteria: Significant congenital heart disease Major malformations Chromosomal anomalies Culture proven sepsis at consent Complex maternal medical conditions Clinical instability Multiple gestations > twins <3rd or >97th percentile for weight85 Participating in another neonatal randomized clinical trial with a competing outcome Mother/legal guardian without stable method of communication

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eCPAP<br>Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met. | Other: Additional 2 weeks of CPAP<br>* Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.<br>|
| No Intervention: dCPAP<br>Participants will discontinue CPAP as per usual care once CPAP stability criteria is met. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar Volume | 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. | 4 - 8 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Diffusion | 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. | 4 - 8 months of age | 
| Forced Expiratory Flows | 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. | 4 - 8 months of age |