CompletedNot Applicable

nHFOV Versus nCPAP in Transient Tachypnea of the Newborn

Turkey (Türkiye)60 participantsStarted 2017-02-01

Plain-language summary

In this prospective, randomised clinical trial the investigators aim to assess if nasal high frequency oscillatory ventilation (nHFOV) could be used as the primary modality of respiratory support in late preterm and term infants with transient tachypnea of the newborn requiring non-invasive ventilation.

Who can participate

Age range

24 Hours

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 at birth between 34 and 42 weeks of gestation * Admission to Bursa Yüksek Ihtisas Teaching Hospital, NICU during the first 24 hours of life * Diagnosis of transient tachypnea of the newborn (TTN) within the first 24 hours of life Exclusion Criteria: * Gestational age at birth less than 34 weeks or greater than 42 weeks at birth * Chest X-ray or lung ultrasound finding indicating another respiratory disorder * Additional infant diagnosis of major cardiac disease * Additional infant diagnosis of major pulmonary disease other than TTN * Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period * Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period

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

Time to cessation of non-invasive positive pressure respiratory support

Timeframe: 72 hours

Trial details

NCT IDNCT03006354

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-30

View on ClinicalTrials.gov More Transient Tachypnea of the Newborn trials