Informations générales (source: ClinicalTrials.gov)
Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
Interventional
N/A
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
novembre 2004
29 juin 2024
Transient tachypnoea of the newborn (TTN) is a common cause of hospitalisation in the
neonatal period, complicating 1 to 1,5 per cent life birth. Predisposing factors are
prematurity, birth after C section, especially before the onset of labor. The main factor
leading to this condition is a lack of absorption of the fluid contained in the alveolar
space resulting in an early respiratory distress which normally resolves in two to five
days with oxygen supplementation.
Meanwhile, some neonates will experience a complicated evolution requiring ventilatory
support and hospitalisatioon in neonatal intensive care unit. This complication is not
preventable and could result either of a surfactant deficiency (primary or secondary) or
a persistent pulmonary hypertension of the neonate (PPHN).
In this study, a cohort of newborn presenting TTN will be followed, in order to evaluate,
at initial admission, pulmonary maturation (with fetal lung maturity test and the stable
microbubble test) and to seek for PPHN (echochardiography). Therapeutic management will
be done according to standard care and classification of the neonate will be performed
according to their clinical evolution: group 1 (uncomplicated TTN) and group 2
(complicated TTN).
Statistical analysis will compare results of the tests at initial evaluation in the two
groups, and accuracy of the tests to predict a complicated evolution will be established.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL PEDIATRIE REEDUCATION BULLION | Pierre KUHN, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Neonate > or = 34 weeks GA admitted in the first 6 hours of life with the suspected
diagnosis of TTN (respiratory rate > 60/mn, SpO2 < 90% in room air, ilvermann score
> 0
- Parental consent obtained
- Neonate > or = 34 weeks GA admitted in the first 6 hours of life with the suspected
diagnosis of TTN (respiratory rate > 60/mn, SpO2 < 90% in room air, ilvermann score
> 0
- Parental consent obtained
- GA> 42 weeks
- meconial amniotic fluid
- early onset neonatal sepsis (septic shock)
- congenital malformations
- enteral feeding started before admission
- no parental consent