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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    130
  • sponsor
    Cynthia McEvoy
Updated on 3 September 2021
continuous positive airway pressure
respiratory distress
extubation

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.

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.

Details
Condition Premature Birth, respiratory distress syndrome of newborn, Premature, Neonatal, Pre-Term, respiratory distress syndrome, preterm delivery, preterm birth, premature delivery, acute respiratory distress syndrome, ards
Treatment Additional 2 weeks of CPAP
Clinical Study IdentifierNCT04295564
SponsorCynthia McEvoy
Last Modified on3 September 2021

Eligibility

Yes No Not Sure

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
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