Hydrocortisone to prevent chronic lung disease in prematurely born newborn infants.

• Conditions: Bronchopulmonary dysplasia; MedDRA version: 14.0Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-023777-19-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-10
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Preterm infants with a gestational age < 30 wks and/or birth weight < 1250 g, ventilator dependency at 7-14 days postnatal age, a respiratory index (RI = MAwP x FiO2) of = 3.5 for more than 12 h/day for at least 48 hours, ensuring adequate oxygen saturation (85-95%) and pCO2 values in premature infants (5.0-7.5 kPa).

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Infants with chromosomal defects (e.g. trisomy 13, 18, 21) or major congenital malformations that compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia), result in chronic ventilation (e.g. Pierre Robin sequence), or increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations) will be excluded.
Also infants who received dexamethasone or hydrocortisone for the sole purpose of improving lung function and respiratory status prior to inclusion, will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified