WithdrawnNot Applicable

Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates

Stopped: Due to changing methodology of the study

Poland0Started 2020-10-01

Plain-language summary

Transient Tachypnea of the Newborn (TTN) is one of the common causes of neonatal respiratory distress as a result of delayed clearance of fetal lung fluid. Neonates with TTN usually require noninvasive respiratory support (e.g. nasal cannula, nasal CPAP) and may need supplemental oxygen therapy to maintain normal oxygen saturation levels. There have also been reports of "malignant TTN," in which affected children develop persistent pulmonary hypertension of the newborn (PPHN).

Who can participate

Age range

10 Minutes – 6 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: * A signed form of informed consent from parents (legal guardians). * 32 0/7 to 41 6/7 weeks of gestation * The need to support postnatal breathing, no later than 6 hours of life. Exclusion Criteria: * The need for intubation in the after-birth procedures * Age above 6 hours of age from birth * Congenital heart defects * Congenital diaphragmatic hernia * Other severe congenital malformations and genetically determined syndromes, diagnosed before and after birth, associated with higher risk of respiratory failure.

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

Rate of PPHN

Timeframe: 12 months

Trial details

NCT IDNCT03499418

SponsorPrincess Anna Mazowiecka Hospital, Warsaw, Poland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-31

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