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

NCT ID: NCT05055193

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Bronchopulmonary Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm infants who received postnatal corticosteroid for bronchopulmonary dysplasia

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

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

Intervention Type 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 did not receive postnatal corticosteroid for bronchopulmonary dysplasia

No corticosteroids

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civil de Lyon

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 37955745 (View on PubMed)

Other Identifiers

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CRC_GHN_2021_005

Identifier Type: -

Identifier Source: org_study_id

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