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Extended CPAP Therapy for Premature Birth

Phase 2 & 3
Waitlist Available
Research Sponsored by Cynthia McEvoy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 - 8 months of age
Awards & highlights

Study Summary

This trial will test whether extra weeks of CPAP in preterm infants can help improve their lung function at 6 months old.

Who is the study for?
This trial is for stable preterm infants born between 24 to 32 weeks who have been on CPAP for respiratory distress. It's not open to those with heart disease, major malformations, chromosomal anomalies, sepsis at consent time, complex maternal conditions, clinical instability or in other competing trials.Check my eligibility
What is being tested?
The study tests if giving an extra two weeks of CPAP therapy can improve lung growth and function in stable preterm infants. The effectiveness will be measured by pulmonary function testing when the infant reaches six months old.See study design
What are the potential side effects?
While the document doesn't specify side effects, common ones associated with prolonged CPAP use may include nasal congestion or irritation, dry mouth, discomfort or sores where the mask touches the face.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 - 8 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 - 8 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alveolar Volume
Secondary outcome measures
Forced Expiratory Flows
Lung Diffusion
Other outcome measures
Bayley III Gross Motor Scores
Respiratory Morbidity

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: eCPAPExperimental Treatment1 Intervention
Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met.
Group II: dCPAPActive Control1 Intervention
Participants will discontinue CPAP as per usual care once CPAP stability criteria is met.

Find a Location

Who is running the clinical trial?

Cynthia McEvoyLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Indiana UniversityOTHER
980 Previous Clinical Trials
982,941 Total Patients Enrolled
4 Trials studying Respiratory Distress Syndrome
1,763 Patients Enrolled for Respiratory Distress Syndrome

Media Library

Additional 2 weeks of CPAP Clinical Trial Eligibility Overview. Trial Name: NCT04295564 — Phase 2 & 3
Respiratory Distress Syndrome Research Study Groups: eCPAP, dCPAP
Respiratory Distress Syndrome Clinical Trial 2023: Additional 2 weeks of CPAP Highlights & Side Effects. Trial Name: NCT04295564 — Phase 2 & 3
Additional 2 weeks of CPAP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04295564 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient is over 30, can they join this trial?

"This study is for babies who are at least 1 day old, but less than 12 weeks old."

Answered by AI
Recent research and studies
The Journal of PediatricsJournal
The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial
Lam, Ryan, Diane Schilling, Brian Scottoline, Astrid Platteau, Meike Niederhausen, Kelli C. Lund, Robert L. Schelonka, Kelvin D. MacDonald, and Cindy T. McEvoy. 2020. “The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2019.07.074.
Pediatric PulmonologyJournal
An Alternative Method to Measure the Diffusing Capacity of the Lung for Carbon Monoxide in Infants
Praca, Eduardo L. L., Christina J. Tiller, Jeffrey A. Kisling, and Robert S. Tepper. 2017. “An Alternative Method to Measure the Diffusing Capacity of the Lung for Carbon Monoxide in Infants”. Pediatric Pulmonology. Wiley. doi:10.1002/ppul.23926.
The Journal of PediatricsJournal
The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial
Lam, Ryan, Diane Schilling, Brian Scottoline, Astrid Platteau, Meike Niederhausen, Kelli C. Lund, Robert L. Schelonka, Kelvin D. MacDonald, and Cindy T. McEvoy. 2020. “The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2019.07.074.
clinicaltrials.govStudy
Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function
Cynthia McEvoy 2020. "Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04295564.
~25 spots leftby Apr 2025
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