Impact of Antenatal Corticosteroid Therapy on Postnatal Surfactant Use in Preterm Infants

NCT ID: NCT05455879

Last Updated: 2024-09-19

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

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-20

Study Completion Date

2022-07-05

Brief Summary

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No study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (HMD) The aim of this study is to assess the impact of the number of doses on the severity of HMD.

Detailed Description

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Respiratory distress syndrome (RDS), formerly known as hyaline membrane disease, is a common problem in preterm infants. This disorder is caused primarily by deficiency of pulmonary surfactant in an immature lung. RDS is a major cause of morbidity and mortality in preterm infants.

Surfactant therapy has been shown to significantly reduce neonatal and infant mortality. Corticosteroids are given antenatal, and then surfactant is given, along with corticosteroids, postnatal.

A single course of corticosteroids is recommended for pregnant women between 24 weeks and 34 weeks of gestation who are at risk of preterm delivery within 7 days, including those with ruptured membranes and multiple pregnancies.

Betamethasone is recommended as the steroid of choice, to be administered in two doses of 12 mg given intramuscularly 24 hours apart.

Conditions

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Hyaline Membrane Disease (HMD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Impact of antenatal corticosteroid therapy on surfactants use postnatal

Intervention Description: Retrospective study on preterm infants to evaluate the impact of antenatal corticosteroid therapy on surfactants use postnatal

Impact of antenatal corticosteroid therapy on surfactants use postnatal

Intervention Type OTHER

Intervention Description: Retrospective study on preterm infants to evaluate the impact of antenatal corticosteroid therapy on surfactants use postnatal

Interventions

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Impact of antenatal corticosteroid therapy on surfactants use postnatal

Intervention Description: Retrospective study on preterm infants to evaluate the impact of antenatal corticosteroid therapy on surfactants use postnatal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Preterm infants ≤ 37 SA
* Hospitalized in the neonatal intensive care unit between January 2018 and December 2019
* Having received at least one dose of corticosteroids antenatal

Exclusion Criteria

* Parental Opposition
* Congenital malformations that may cause neonatal respiratory distress.
Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital NOVO

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Suzanne BORRHOMEE

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

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Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos

Pontoise, , France

Site Status

Countries

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France

Other Identifiers

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CHRD0822

Identifier Type: -

Identifier Source: org_study_id

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