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

Transient Tachypnoea of the Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00213941
• Other study ID #: 3214
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 2, 2006
• Start date: November 2004

Study information

• Verified date: October 2006
• Source: University Hospital, Strasbourg, France
• Contact: Pierre KUHN, MD
• Phone: 33.3.88.12.77.79
• Email: Pierre.Kuhn[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Hours

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea of the Newborn
• Transient Tachypnoea of the Newborn

Intervention

Device:
• Echocardiography

Locations

Country	Name	City	State
France	Service de Pédiatrie 2, Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN
Secondary	Increase the knowledge in the physiopathology of TTN