Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
Recruitment status was Recruiting
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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: Open Label Primary Purpose: Diagnostic |
| Official Title: | Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates |
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| 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| Contact: Pierre KUHN, MD | 33.3.88.12.77.79 | Pierre.Kuhn@chru-strasbourg.fr |
| 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 | |
| Principal Investigator: | Pierre KUHN, MD | Service de Pédiatrie, Hôpital de Hautepierre |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00213941 History of Changes |
| Other Study ID Numbers: | 3214 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 2, 2006 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Strasbourg, France:
|
transient tachypnoea of the newborn surfactant deficiency persistant pulmonary hypertension of the neonate lung maturity tests |
ClinicalTrials.gov processed this record on May 16, 2013