Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00213941
Enrollment
100
Registered
2005-09-21
Start date
2004-11-30
Completion date
Unknown
Last updated
2006-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Tachypnoea of the Newborn

Keywords

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

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.

Interventions

DEVICEEchocardiography

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 6 Hours
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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Increase the knowledge in the physiopathology of TTN

Countries

France

Contacts

Primary ContactPierre KUHN, MD
Pierre.Kuhn@chru-strasbourg.fr33.3.88.12.77.79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026