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High CPAP, then traditional CPAP, then NIPPV. for Premature Birth

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Recruiting

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours per each mode of ventilation, total of 6 hours

Awards & highlights

Study Summary

This trial compares two methods of providing breathing support to premature babies: CPAP and NIPPV. CPAP delivers constant pressure to the baby's lungs to help with breathing, while NIPPV delivers

Who is the study for?

This trial is for very low birth weight preterm infants who need breathing support due to immature lungs. It's not suitable for those with certain medical conditions that the study doesn't specify.Check my eligibility

What is being tested?

The study tests how different non-invasive breathing supports affect diaphragm activity in premature babies. It compares traditional CPAP, NIPPV, and high-pressure CPAP to see which helps their tiny lungs best.See study design

What are the potential side effects?

While specific side effects are not detailed, interventions like CPAP and NIPPV may cause nasal irritation or discomfort in some infants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours per each mode of ventilation, total of 6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours per each mode of ventilation, total of 6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours per each mode of ventilation, total of 6 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

The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O).

Secondary outcome measures

1. Neural respiratory rate per minute

2. Edi peak measured in MicroVoltage

3. The difference in transcutaneous pCO2 in mmHg

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Traditional CPAP, then high CPAP, then NIPPVExperimental Treatment1 Intervention

The participant will stay for 2 hours on Traditional CPAP, then 2 hours on high CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods.

Group II: Traditional CPAP, then NIPPV, then high CPAP.Experimental Treatment1 Intervention

The participant will stay for 2 hours on Traditional CPAP, then 2 hours on NIPPV, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods.

Group III: NIPPV, then traditional CPAP, then high CPAPExperimental Treatment1 Intervention

The participant will stay for 2 hours on NIPPV, then 2 hours on traditional CPAP, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods.

Group IV: NIPPV, then high CPAP, then traditional CPAP.Experimental Treatment1 Intervention

The participant will stay for 2 hours on NIPPV, then 2 hours on high CPAP, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods.

Group V: High CPAP, then traditional CPAP, then NIPPV.Experimental Treatment1 Intervention

The participant will stay for 2 hours on High CPAP, then 2 hours on traditional CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods.

Group VI: High CPAP, then NIPPV, then traditional CPAP.Experimental Treatment1 Intervention

The participant will stay for 2 hours on High CPAP, then 2 hours on NIPPV, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,283 Total Patients Enrolled

11 Trials studying Premature Birth

3,505 Patients Enrolled for Premature Birth

Frequently Asked Questions

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

Is this medical study open to individuals who are 75 years of age or older?

"Individuals who have reached the age of 1 day and are under 8 months old are eligible to participate in this clinical trial."

Answered by AI

What is the cap on participant enrollment for this research investigation?

"Yes, as per details on clinicaltrials.gov, this study is actively seeking candidates. The trial was initially shared on August 21st, 2021 and last modified on March 5th, 2024. It aims to enroll a total of 24 participants at a single location."

Answered by AI

Am I eligible to participate in this research study?

"Patients eligible for inclusion in this research study must exhibit symptoms of respiratory distress syndrome and fall within the age range from 1 day to 8 months. Approximately 24 individuals will be accepted into the trial."

Answered by AI

Are there any available slots for patients to participate in this research study?

"According to clinicaltrials.gov, this current trial is actively seeking participants. The information was initially posted on August 21st, 2021 and most recently modified on March 5th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

2021. "Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06295484.