We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

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.
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
Information provided by:

Study Description
Brief Summary:

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
Transient Tachypnoea of the Newborn Device: Echocardiography

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : November 2004

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Increase the knowledge in the physiopathology of TTN

Eligibility Criteria

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

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

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

Service de Pédiatrie 2, Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Pierre KUHN, MD    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
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 Posted: September 21, 2005    Key Record Dates
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:
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