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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 below

NICA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of intervention (12 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of intervention (12 hours) for reporting.

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 more

NICA 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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Mar 2025