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CPAP first for Respiratory Distress Syndrome (NICA Trial)
N/A
Waitlist Available
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gestational Age 23-34 completed weeks
Stable on non- invasive respiratory support for at least 24h
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of intervention (12 hours)
Awards & highlights
NICA Trial Summary
This study is evaluating whether a breathing machine that intermittently increases pressure applied to the nostrils is as effective as standard continuous positive airway pressure.
Eligible Conditions
- Respiratory Distress Syndrome
- Primary Apnea of Prematurity
- Premature Infants
NICA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNICA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of intervention (12 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of intervention (12 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Apnea/bradycardia events
Secondary outcome measures
Instances of treatment failure
Mean degrees of phase lag by RIP
Mean fraction of inspired oxygen
+5 moreNICA Trial Design
2Treatment groups
Active Control
Group I: CPAP firstActive Control2 Interventions
The intervention is application of continuous positive airway pressure (CPAP). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.
Group II: NIPPV firstActive Control2 Interventions
The intervention is application of nasal intermittent positive pressure ventilation (NIPPV). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.
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Who is running the clinical trial?
Women and Infants Hospital of Rhode IslandLead Sponsor
107 Previous Clinical Trials
38,430 Total Patients Enrolled
Sunil Shaw, PhDStudy DirectorBrown University
Frequently Asked Questions
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