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

Overview

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.

Full Title of Study: “Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2023

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.

Interventions

  • Other: Additional 2 weeks of CPAP
    • Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.

Arms, Groups and Cohorts

  • Experimental: eCPAP
    • Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met.
  • No Intervention: dCPAP
    • Participants will discontinue CPAP as per usual care once CPAP stability criteria is met.

Clinical Trial Outcome Measures

Primary Measures

  • Alveolar Volume
    • Time Frame: 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 Measures

  • Lung Diffusion
    • Time Frame: 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.
  • Forced Expiratory Flows
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 12 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cynthia McEvoy
  • Collaborator
    • Indiana University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Cynthia McEvoy, Principal Investigator – Oregon Health and Science University
  • Overall Contact(s)
    • Cindy McEvoy, MD, MCR, 503-494-0223, mcevoyc@ohsu.edu

References

Lam R, Schilling D, Scottoline B, Platteau A, Niederhausen M, Lund KC, Schelonka RL, MacDonald KD, McEvoy CT. The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial. J Pediatr. 2020 Feb;217:66-72.e1. doi: 10.1016/j.jpeds.2019.07.074. Epub 2019 Sep 10.

Praca ELL, Tiller CJ, Kisling JA, Tepper RS. An alternative method to measure the diffusing capacity of the lung for carbon monoxide in infants. Pediatr Pulmonol. 2018 Mar;53(3):332-336. doi: 10.1002/ppul.23926. Epub 2017 Dec 19.

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