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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
No Placebo-Only Group

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.
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.
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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,039 Previous Clinical Trials
1,218,928 Total Patients Enrolled
5 Trials studying Respiratory Distress Syndrome
3,275 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
~22 spots leftby Nov 2025
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