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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213941
First received: September 13, 2005
Last updated: October 2, 2006
Last verified: October 2006

September 13, 2005
October 2, 2006
November 2004
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Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN
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Complete list of historical versions of study NCT00213941 on ClinicalTrials.gov Archive Site
Increase the knowledge in the physiopathology of TTN
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Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
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.

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Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Transient Tachypnoea of the Newborn
Device: Echocardiography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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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
Both
up to 6 Hours
No
Contact: Pierre KUHN, MD 33.3.88.12.77.79 Pierre.Kuhn@chru-strasbourg.fr
France
 
NCT00213941
3214
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University Hospital, Strasbourg, France
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Principal Investigator: Pierre KUHN, MD Service de Pédiatrie, Hôpital de Hautepierre
University Hospital, Strasbourg, France
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP