CompletedNot Applicable

Comparison of Efficacy of Less Invasive Surfactant Treatment Under Nasal CPAP and Nasal IPPV

Turkey (Türkiye)85 participantsStarted 2020-10-01

Plain-language summary

Non invasive ventilation is important in the care of preterm infants with respiratory failure, and surfactant treatment can be use with non invasive ventilation. However, there is no consensus on the best non-invasive ventilation mode for surfactant treatment in preterm infants. Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (CPAP) in preterm infants ≤ 29 week gestational age.

Who can participate

Age range

24 Weeks – 29 Weeks

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: * Gestational age 24 -29 week * Clinical and radiological diagnosis of RDS * Born in a hospital with a study center * Spontaneous breathing * Within the first 6 hours * Non-invasive ventilation and FiO2 requirement \>0.30 * Parental concent Exclusion Criteria: * Major congenital malformations * Need of mechanical ventiation * Need of entubation in delivery room * Air weak syndrome * No parental concent

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

Treatment failure within 72 hours after randomization 72 hours after randomization

Timeframe: within 72 hours after randomization

Trial details

NCT IDNCT04698473

SponsorUludag University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

View on ClinicalTrials.gov More Respiratory Distress Syndrome trials