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

Bronchopulmonary Dysplasia Clinical Trial

— DEPRECOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055193
• Other study ID #: CRC_GHN_2021_005
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2018
• Est. primary completion date: January 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Drug:
• Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome
Data concerning the 24 months corrected age outcomes were collected from the medical records of the ECL'AUR preterm infants follow-up network.

Locations

Country	Name	City	State
France	Hospices Civil de Lyon	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	at 24 months corrected age