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

Primary Purpose

Transient Tachypnoea of the Newborn

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Echocardiography

About this trial

This is an interventional diagnostic trial for Transient Tachypnoea of the Newborn focused on measuring transient tachypnoea of the newborn, surfactant deficiency, persistant pulmonary hypertension of the neonate, lung maturity tests

Eligibility Criteria

0 Years - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Pédiatrie 2, Hôpital de HautepierreRecruiting

Outcomes

Primary Outcome Measures

Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN

Secondary Outcome Measures

Increase the knowledge in the physiopathology of TTN

Full Information

NCT ID

NCT00213941

First Posted

September 13, 2005

Last Updated

October 2, 2006

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00213941

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Unknown status

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transient Tachypnoea of the Newborn

Keywords

transient tachypnoea of the newborn, surfactant deficiency, persistant pulmonary hypertension of the neonate, lung maturity tests

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Echocardiography

Primary Outcome Measure Information:

Title

Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN

Secondary Outcome Measure Information:

Title

Increase the knowledge in the physiopathology of TTN

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

6 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre KUHN, MD

Phone

33.3.88.12.77.79

Pierre.Kuhn@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre KUHN, MD

Organizational Affiliation

Service de Pédiatrie, Hôpital de Hautepierre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Pédiatrie 2, Hôpital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre KUHN, MD

Phone

33.3.88.12.77.79

Pierre.Kuhn@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

MESSER Jean, MD

First Name & Middle Initial & Last Name & Degree

MATIS Jacqueline, MD

First Name & Middle Initial & Last Name & Degree

ASTRUC Dominique, MD

First Name & Middle Initial & Last Name & Degree

DONATO Leonardo, MD

First Name & Middle Initial & Last Name & Degree

ESCANDE Benoît, MD

12. IPD Sharing Statement

Learn more about this trial

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

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