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 range10 Minutes – 6 Hours

SexALL

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.

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