Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedOctober 3, 2006
October 1, 2006
September 13, 2005
October 2, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN
Secondary Outcomes (1)
Increase the knowledge in the physiopathology of TTN
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- GA\> 42 weeks
- meconial amniotic fluid
- early onset neonatal sepsis (septic shock)
- congenital malformations
- enteral feeding started before admission
- no parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Pédiatrie 2, Hôpital de Hautepierre
Strasbourg, 67098, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre KUHN, MD
Service de Pédiatrie, Hôpital de Hautepierre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
November 1, 2004
Last Updated
October 3, 2006
Record last verified: 2006-10