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High CPAP Pressures for Premature Neonates Post-extubation

Q: Who has the qualifications to be accepted into this clinical investigation?

To qualify for this research, participants must exhibit respiratory distress syndrome and be newborns between the ages of 7 days and 37 weeks. <a href="https://www.withpower.com/clinical-trials/all">All</a> in all, 26 subjects are required to complete the trial.

Q: Are senior citizens aged 80 and younger suitable candidates for this medical trial?

According to the study's admission requirements, neonates aged 7 days up to full-term infants of 37 weeks are invited to register for this clinical trial.

Q: Are new participants being admitted to the research project?

As indicated by information on clinicaltrials.gov, recruitment for this study has been suspended. The trial was listed on February 15th 2022 and the last change made to its listing was January 28th 2022. Although this research is not presently recruiting participants, there are currently 445 other trials that need volunteers.

N/A

Waitlist Available

Led By Amit Mukerji, MD

Research Sponsored by McMaster Children's Hospital

Eligibility Criteria Checklist

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

Must have

Chronological age >7 days

Post-menstrual age <37 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over entire duration (70 min) at each cpap level, assessed every 10 min

Awards & highlights

Study Summary

This trial will compare the short-term effects of two different CPAP pressures on preterm neonates after they have been extubated.

Who is the study for?

This trial is for preterm babies who were born before 37 weeks of pregnancy, are older than 7 days but were born at less than 29 weeks. They should have been on a ventilator with certain pressure settings and not have any genetic abnormalities.Check my eligibility

What is being tested?

The study tests two different high-pressure levels of CPAP (continuous positive airway pressure) as breathing support after removing a premature baby from a ventilator to see which one works better in the short term.See study design

What are the potential side effects?

While the trial description doesn't specify side effects, generally, higher CPAP pressures can cause discomfort, nasal injury or potential lung injury in neonates.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am older than 7 days.

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My baby was born before 37 weeks of pregnancy.

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I was recently taken off a ventilator with specific airway pressure settings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over entire duration (70 min) at each cpap level, assessed every 10 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over entire duration (70 min) at each cpap level, assessed every 10 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and over entire duration (70 min) at each cpap level, assessed every 10 min for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Peak Edi

Secondary outcome measures

FiO2 level

Heart Rate

Minimum EDi

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Higher CPAPExperimental Treatment1 Intervention

CPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure

Group II: Equivalent CPAPActive Control1 Intervention

CPAP level will be equal to the pre-extubation measured mean airway pressure

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster Children's HospitalLead Sponsor

38 Previous Clinical Trials

17,299 Total Patients Enrolled

Amit Mukerji, MDPrincipal InvestigatorAssociate Professor

Media Library

CPAP level Clinical Trial Eligibility Overview. Trial Name: NCT05230485 — N/A

Neonatal Respiratory Distress Syndrome Research Study Groups: Higher CPAP, Equivalent CPAP

Neonatal Respiratory Distress Syndrome Clinical Trial 2023: CPAP level Highlights & Side Effects. Trial Name: NCT05230485 — N/A

CPAP level 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230485 — N/A

Frequently Asked Questions

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

Who has the qualifications to be accepted into this clinical investigation?

"To qualify for this research, participants must exhibit respiratory distress syndrome and be newborns between the ages of 7 days and 37 weeks. All in all, 26 subjects are required to complete the trial."

Answered by AI

Are senior citizens aged 80 and younger suitable candidates for this medical trial?

"According to the study's admission requirements, neonates aged 7 days up to full-term infants of 37 weeks are invited to register for this clinical trial."

Answered by AI

Are new participants being admitted to the research project?

"As indicated by information on clinicaltrials.gov, recruitment for this study has been suspended. The trial was listed on February 15th 2022 and the last change made to its listing was January 28th 2022. Although this research is not presently recruiting participants, there are currently 445 other trials that need volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimal High CPAP Pressures in Preterm Neonates Post-extubation

Amit Mukerji 2022. "Optimal High CPAP Pressures in Preterm Neonates Post-extubation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05230485.