Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 2, 2006 | ||||
| Start Date ICMJE | November 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00213941 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Increase the knowledge in the physiopathology of TTN | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates | ||||
| Official Title ICMJE | Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Transient Tachypnoea of the Newborn | ||||
| Intervention ICMJE | Device: Echocardiography | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 6 Hours | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00213941 | ||||
| Other Study ID Numbers ICMJE | 3214 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospital, Strasbourg, France | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Strasbourg, France | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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