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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civil de Lyon

Lyon, Auvergne-Rhône-Alpes, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DEPRECOD

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2018
First posted: Sep 24, 2021
Registry last updated: Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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