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
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
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: OtherdCPAPNoIntervention 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.
References
- 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.
- 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.
- 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.
- Cynthia McEvoy 2020. "Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04295564.
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Conditions
Cancer Related
Treatments