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NCT Number: NCT04295564

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

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.

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Key information

Conditions

Neonatal Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

1 day–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doernbecher Neonatal Care Center at Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional 2 weeks of CPAP

Other

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

Primary outcomes

  1. 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. Measurements of alveolar volume were obtained at the same time as measurements of lung diffusion using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.

Secondary outcomes

  1. 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. Measurements of lung diffusion were obtained at the same time as measurements of alveolar volume using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.

  2. Forced Expiratory Flows at 50% of the Expired Volume (FEF50)

    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. Forced expiratory flows were measured using the raised volume rapid thoracic compression technique following specific American Thoracic Society and European Respiratory Society criteria for acceptance.

Other outcomes

  1. Number of Participants With the Occurrence of Wheeze

    Time frame: 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. A standardized respiratory questionnaire was administered monthly through 12 months of age to ascertain this information on wheeze which was defined a priori.

  2. Bayley III Gross Motor Scores

    Time frame: 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. These exams were performed by a licensed psychologist in the neurodevelopmental clinic.

Sponsors and collaborators

Lead sponsor

Cynthia McEvoy

Other

Collaborators

  • Indiana University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 4, 2020
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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