Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
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|ClinicalTrials.gov Identifier: NCT00213941|
Recruitment Status : Unknown
Verified October 2006 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
First Posted : September 21, 2005
Last Update Posted : October 3, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Transient Tachypnoea of the Newborn||Device: Echocardiography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates|
|Study Start Date :||November 2004|
- Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN
- Increase the knowledge in the physiopathology of TTN
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213941
|Contact: Pierre KUHN, MD||220.127.116.11.77.79||Pierre.Kuhn@chru-strasbourg.fr|
|Service de Pédiatrie 2, Hôpital de Hautepierre||Recruiting|
|Strasbourg, France, 67098|
|Contact: Pierre KUHN, MD 18.104.22.168.77.79 Pierre.Kuhn@chru-strasbourg.fr|
|Sub-Investigator: MESSER Jean, MD|
|Sub-Investigator: MATIS Jacqueline, MD|
|Sub-Investigator: ASTRUC Dominique, MD|
|Sub-Investigator: DONATO Leonardo, MD|
|Sub-Investigator: ESCANDE Benoît, MD|
|Principal Investigator:||Pierre KUHN, MD||Service de Pédiatrie, Hôpital de Hautepierre|