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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213941
First Posted: September 21, 2005
Last Update Posted: October 3, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Strasbourg, France
  Purpose

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 Intervention
Transient Tachypnoea of the Newborn Device: Echocardiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN

Secondary Outcome Measures:
  • Increase the knowledge in the physiopathology of TTN

Estimated Enrollment: 100
Study Start Date: November 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Pierre KUHN, MD 33.3.88.12.77.79 Pierre.Kuhn@chru-strasbourg.fr

Locations
France
Service de Pédiatrie 2, Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Pierre KUHN, MD    33.3.88.12.77.79    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         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pierre KUHN, MD Service de Pédiatrie, Hôpital de Hautepierre
  More Information

ClinicalTrials.gov Identifier: NCT00213941     History of Changes
Other Study ID Numbers: 3214
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 3, 2006
Last Verified: October 2006

Keywords provided by University Hospital, Strasbourg, France:
transient tachypnoea of the newborn
surfactant deficiency
persistant pulmonary hypertension of the neonate
lung maturity tests

Additional relevant MeSH terms:
Tachypnea
Transient Tachypnea of the Newborn
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Distress Syndrome, Newborn
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases