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Continuous positive airway pressure for Respiratory Distress Syndrome (COCO Trial)

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours of intervention

Awards & highlights

COCO Trial Summary

This trial will compare CPAP and NC oxygen in preterm infants to see which decreases the number of episodes with oxygen saturations less than 85%.

Eligible Conditions

Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Hypoxia
Neonatal Disease

COCO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds

Secondary outcome measures

The coefficient of variability of oxygen saturations (relative standard deviation)

The median aNIRS value

The median cNIRS value

+7 more

Side effects data

From 2020 Phase 4 trial • 74 Patients • NCT01807897

16%

Increased dyspnea

Excessive sleepiness

Heart failure

Fall

Stroke

Bronchitis

Pneumonia

Toothache

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

CPAP

Oxygen

HLSE

COCO Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Continuous positive airway pressureExperimental Treatment1 Intervention

Continuous positive airway pressure (CPAP) with blended oxygen delivered by binasal prongs or nasal mask.

Group II: Nasal CannulaActive Control1 Intervention

Blended oxygen delivered by nasal cannula (NC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous positive airway pressure

2016

Completed Phase 4

~1710

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Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,589 Previous Clinical Trials

2,280,316 Total Patients Enrolled

6 Trials studying Respiratory Distress Syndrome

1,342 Patients Enrolled for Respiratory Distress Syndrome

Waldemar A Carlo, MDStudy DirectorUniversity of Alabama at Birmingham

26 Previous Clinical Trials

127,231 Total Patients Enrolled

2 Trials studying Respiratory Distress Syndrome

72 Patients Enrolled for Respiratory Distress Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolment currently available for this research endeavor?

"As per data hosted on clinicaltrials.gov, this trial is no longer in need of volunteers as it was initially created on August 16th 2021 and last updated on the 2nd of August 2022. Nonetheless, there are 384 other trials currently searching for participants to join their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial

Siamak Yazdi 2021. "CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04792099.