Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates

Conditions
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Transient Tachypnoea of the Newborn

Intervention / Treatment
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* Device: Echocardiography


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: GA> 42 weeks meconial amniotic fluid early onset neonatal sepsis (septic shock) congenital malformations enteral feeding started before admission no parental consent

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Echocardiography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the knowledge in the physiopathology of TTN |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung maturity tests, transient tachypnoea of the newborn, surfactant deficiency, persistant pulmonary hypertension of the neonate