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

Sponsor
Cynthia McEvoy (Other)
Overall Status
Recruiting
CT.gov ID
NCT04295564
Collaborator
Indiana University (Other)
130
Enrollment
1
Location
2
Arms
47.7
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Additional 2 weeks of CPAP
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial
Actual Study Start Date :
Jan 10, 2020
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: eCPAP

Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met.

Other: Additional 2 weeks of CPAP
Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.
No Intervention: dCPAP

Participants will discontinue CPAP as per usual care once CPAP stability criteria is met.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Other Outcome Measures

  1. Respiratory Morbidity [through 12 months of age (+/- 2 months)]

    Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in lower respiratory morbidity through 12 months of age compared to infants who had CPAP discontinued, usual care

  2. Bayley III Gross Motor Scores [through 12 months of age (+/- 2 months)]

    Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in improved neurodevelopmental outcomes (Bayley III Gross Motor Scores) through 12 months of age compared to infants who had CPAP discontinued, usual care

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 12 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Doernbecher Neonatal Care Center at Oregon Health & Science University Portland Oregon United States 97239

Sponsors and Collaborators

  • Cynthia McEvoy
  • Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cynthia McEvoy, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT04295564
Other Study ID Numbers:
  • eCPAP
First Posted:
Mar 4, 2020
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Premature Birth

Study Results

No Results Posted as of Aug 26, 2021