Transient Tachypnea of the Newborn Clinical Trial
— PRE-HIFREQOfficial title:
Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Term and Near-term Neonates - Observational Study
Verified date | September 2022 |
Source | Princess Anna Mazowiecka Hospital, Warsaw, Poland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 30, 2024 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Minutes to 6 Hours |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Princess Anna Mazowiecka Hospital, Warsaw, Poland |
Poland,
Buchiboyina A, Jasani B, Deshmukh M, Patole S. Strategies for managing transient tachypnoea of the newborn - a systematic review. J Matern Fetal Neonatal Med. 2017 Jul;30(13):1524-1532. doi: 10.1080/14767058.2016.1193143. Epub 2016 Oct 20. Review. — View Citation
Lakshminrusimha S, Keszler M. Persistent Pulmonary Hypertension of the Newborn. Neoreviews. 2015 Dec;16(12):e680-e692. — View Citation
Raju TN, Higgins RD, Stark AR, Leveno KJ. Optimizing care and outcome for late-preterm (near-term) infants: a summary of the workshop sponsored by the National Institute of Child Health and Human Development. Pediatrics. 2006 Sep;118(3):1207-14. — View Citation
Rubaltelli FF, Dani C, Reali MF, Bertini G, Wiechmann L, Tangucci M, Spagnolo A. Acute neonatal respiratory distress in Italy: a one-year prospective study. Italian Group of Neonatal Pneumology. Acta Paediatr. 1998 Dec;87(12):1261-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of PPHN | The primary endpoint for this study is time of respiratory failure (need to intubation) and incidence rate of PPHN | 12 months | |
Secondary | The evaluation of the "TTN scale" | The evaluation of the "TTN scale" in comparison to physiologic parameters:
Fraction of inspired oxygen (FiO2) pH Partial pressure of carbon dioxide (pCO2) |
12 months |
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