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

NCT05055193 | Completed

• 1 other identifier: CRC_GHN_2021_005
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Preterm infants who received postnatal corticosteroid for bronchopulmonary dysplasia

Corticosteroids used are hydrocortisone (as first-line therapy) and betamethasone (in situations of particular severity)

Drug: Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome

Preterm infants who did not receive postnatal corticosteroid for bronchopulmonary dysplasia

No corticosteroids

Interventions

Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome DRUG

Data concerning the 24 months corrected age outcomes were collected from the medical records of the ECL'AUR preterm infants follow-up network.

Preterm infants who received postnatal corticosteroid for bronchopulmonary dysplasia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Extremely preterm infants less than 29 weeks' gestation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civil de Lyon

Lyon, Auvergne-Rhône-Alpes, 69004, France

Location

Related Publications (1)

• Melan N, Pradat P, Godbert I, Pastor-Diez B, Basson E, Picaud JC. Neurodevelopment at 24 months corrected age in extremely preterm infants treated with dexamethasone alternatives during the late postnatal period: a cohort study. Eur J Pediatr. 2024 Feb;183(2):677-687. doi: 10.1007/s00431-023-05319-z. Epub 2023 Nov 13.

  PMID: 37955745 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: January 1, 2013
• Primary Completion: January 1, 2013
• Study Completion: December 31, 2018
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

FR (1)