CompletedNot Applicable

Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants

Canada10 participantsStarted 2011-05

Plain-language summary

In this study, the investigators want to observe how continuous positive airway pressure delivered by two different modalities affects breathing pattern in small preterm infants. Using a specialized feeding tube in the stomach, the investigators can measure and compare how the diaphragm (a large breathing muscle) might be affected by those two modalities.

Who can participate

Age range

2 Days – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Birth weights ≤ 1500g * Gestational age less than 32 week * Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours * Treated with methylxanthines for apnea of prematurity * In less than 35% oxygen Exclusion Criteria: * Congenital and acquired problem of the gastrointestinal tract * Phrenic nerve injury and/or diaphragm paralysis * Esophageal perforation/tracheoesophageal fistula * Congenital/acquired neurological deficit and/or seizures * Hemodynamic instability * Congenital heart disease (including symptomatic patent ductus arteriosus) * Undergoing treatment for sepsis or pneumonia * Use of muscle relaxants, narcotic analgesics, or gastric motility agents * Congenital anomalies of respiratory tract (e.g. CCAM) * Infants requiring more than 35% oxygen * Infants with facial anomalies * Infants with pneumothorax and/or pneumomediatinum * Infants in the immediate postoperative period * Infants with significant gastric residues and vomiting

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The difference in the tonic EAdi between IF-CPAP and HFNC .

Timeframe: During the 4-hour study period.

Trial details

NCT IDNCT01326975

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Continuous Positive Airway Pressure trials