Additional 2 weeks of CPAP for Respiratory Distress Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Respiratory Distress Syndrome+2 MoreAdditional 2 weeks of CPAP - Other
Eligibility
1 - 12
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Respiratory Distress Syndrome
  • Premature Birth
  • Neonatal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 4 - 8 months of age

Month 8
Alveolar Volume
Forced Expiratory Flows
Lung Diffusion
Month 12
Bayley III Gross Motor Scores
Respiratory Morbidity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

dCPAP
1 of 2
eCPAP
1 of 2

Active Control

Experimental Treatment

130 Total Participants · 2 Treatment Groups

Primary Treatment: Additional 2 weeks of CPAP · No Placebo Group · Phase 2 & 3

eCPAP
Other
Experimental Group · 1 Intervention: Additional 2 weeks of CPAP · Intervention Types: Other
dCPAPNoIntervention Group · 1 Intervention: dCPAP · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 - 8 months of age

Who is running the clinical trial?

Cynthia McEvoyLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Indiana UniversityOTHER
876 Previous Clinical Trials
749,446 Total Patients Enrolled
3 Trials studying Respiratory Distress Syndrome
1,163 Patients Enrolled for Respiratory Distress Syndrome

Eligibility Criteria

Age 1 - 12 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
have a lower risk of mortality than those born at <24 weeks gestation
The patient was treated with CPAP for 24 hours or more for respiratory distress.