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

NCT ID: NCT00213941

Last Updated: 2006-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

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.

Detailed Description

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Conditions

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Transient Tachypnoea of the Newborn

Keywords

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transient tachypnoea of the newborn surfactant deficiency persistant pulmonary hypertension of the neonate lung maturity tests

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Echocardiography

Intervention Type DEVICE

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
Minimum Eligible Age

0 Years

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Principal Investigators

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Pierre KUHN, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Pédiatrie, Hôpital de Hautepierre

Locations

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Service de Pédiatrie 2, Hôpital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre KUHN, MD

Role: CONTACT

Phone: 33.3.88.12.77.79

Email: [email protected]

Facility Contacts

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Pierre KUHN, MD

Role: primary

Other Identifiers

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3214

Identifier Type: -

Identifier Source: org_study_id