Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia

Completed

• Conditions: Bronchopulmonary Dysplasia

• Registration Number: NCT05055193
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2013-01-01
• Study Completion: 2018-12-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Extremely preterm infants less than 29 weeks' gestation
• Infants hospitalized for at least the first 30 days of life in the neonatology department of the Croix-Rousse Hospital in Lyon
• Infants born between January 1, 2013 and December 31, 2016

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Exclusion Criteria

• Infants with a congenital heart, lung or brain malformation
• Infants with a neuromuscular disease
• Infants with a genetic disorder
• Infants who died before the age of 24 months corrected age
• Infants lost to follow-up or with incomplete data at 24 months corrected age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary outcome combining: - Respiratory evolution at 24 months corrected age - Neurodevelopmental evolution at 24 months corrected age - Growth evolution at 24 months corrected age	at 24 months corrected age	* Respiratory evolution at 24 months corrected age: asthma, inhaled corticosteroid therapy, respiratory events, hospitalizations for respiratory events.; * Neurodevelopmental evolution at 24 months corrected age: developmental quotient of the revised Brunet Lézine scale, visual and auditory anomalies, cerebral palsy.; * Growth evolution at 24 months corrected age: weight, height and head circumference at 24 months.

Trial Locations

Locations (1)

Hospices Civil de Lyon; 🇫🇷 Lyon, Rhone Alpes, France