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CPAP Methods for Premature Infants

N/A

Waitlist Available

Led By Marilyn D Hyndman

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

≤ 1500 grams at birth

Intubated infant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is examining whether one of two types of CPAP is better at supporting the extubation of premature infants.

Who is the study for?

This trial is for intubated infants weighing ≤ 1500 grams at birth, where the clinical team has decided to extubate to CPAP. Parents or guardians must provide written consent. Infants with airway anomalies, severe brain lesions (grade III/IV periventricular leukomalacia), or suspected genetic syndromes cannot participate.Check my eligibility

What is being tested?

The study compares two types of CPAP support systems—Bubble CPAP and Infant Flow System—to see which is more effective in helping premature babies <1500 grams stay off a ventilator after being extubated. It's a randomised controlled trial with each infant assigned randomly to one of the two methods.See study design

What are the potential side effects?

While specific side effects are not listed, both CPAP methods may cause discomfort, nasal injury or contribute to lung problems due to pressure changes. Close monitoring will help manage any potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weighed 1500 grams or less when I was born.

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My infant is on a breathing machine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

failure of extubation as defined by the following: pH < 7.25 and PCO2 > 65 (or an increase of 15 mmHg from pre-extubation), a sustained (> 1 hour) increase in FiO2 of .15 (as compared to pre-extubation) or significant apno

Secondary outcome measures

assessment of pain will

average weight gain on CPAP

corrected gestational age at cessation of CPAP

+2 more

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,232 Total Patients Enrolled

3 Trials studying Respiratory Insufficiency

968 Patients Enrolled for Respiratory Insufficiency

Ontario Lung AssociationOTHER

19 Previous Clinical Trials

1,060 Total Patients Enrolled

2 Trials studying Respiratory Insufficiency

126 Patients Enrolled for Respiratory Insufficiency

Marilyn D HyndmanPrincipal InvestigatorSunnybrook & Women's College Health Sciences Centre

Media Library

Bubble CPAP (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00187434 — N/A

Respiratory Insufficiency Research Study Groups:

Respiratory Insufficiency Clinical Trial 2023: Bubble CPAP Highlights & Side Effects. Trial Name: NCT00187434 — N/A

Bubble CPAP (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00187434 — N/A

Frequently Asked Questions

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

Are there any openings for individuals to join this research project?

"According to clinicaltrials.gov, this specific medical experiment is not currently enrolling subjects. The original post for the trial was dated September 1st, 2003 and it last modified on January 22nd 2007. Despite this particular study being inactive as of present, 466 similar trials remain in search of participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP)

2003. "Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00187434.