Transient Tachypnoea of the Newborn Clinical Trial
Official title:
Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
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.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01407848 -
Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
|
Phase 2 |