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

Impact of the Number of Doses of Antenatal Corticosteroid Therapy on the Number of Doses of Surfactants Postnatal in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Hyaline Membrane Disease (HMD)
• Intervention / Treatment: Other: Impact of antenatal corticosteroid therapy on surfactants use postnatal

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• France
  • Pontoise, France
    • Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants (≤ 37 SA), hospitalized in the neonatal intensive care unit between January 2018 and December 2019 and having received at least one dose of corticosteroids antenatal

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the effect of a full course of antenatal corticosteroid therapy versus a half course on the number of postnatal surfactant doses in preterm infants.	Comparison of the number of doses of surfactants administered postnatal in preterm infants who received 2 doses of antenatal corticosteroid therapy versus those who received a single dose	At the end of the study, an average of 2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the influence of gestational age on the severity of hyaline membrane disease (HMD)	Radiological stage of HMD according to gestational age : Stage 1 : reticulo-granular appearance / borderline normal imaging of the lung, Stage 2 : diffuse reticulo-granular appearance / Visible mediastinal borders Stage 3 : global decrease in lung transparency / Bronchogram aerial / Blurred mediastinal borders Stage 4 : white lungs	At the end of the study, an average of 2 month
Assessment of the influence of the cause of prematurity on the severity of hyaline membrane disease (HMD)	Radiological stage of HMD according to cause of prematurity : Stage 1 : reticulo-granular appearance / borderline normal imaging of the lung, Stage 2 : diffuse reticulo-granular appearance / Visible mediastinal borders Stage 3 : global decrease in lung transparency / Bronchogram aerial / Blurred mediastinal borders Stage 4 : white lungs	At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the use of postnatal corticosteroid therapy	Prevalence of postnatal corticosteroid therapy by number of doses of antenatal corticosteroid therapy	At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the prevalence of bronchopulmonary dysplasia	Prevalence of bronchopulmonary dysplasia as a function of the number of doses of antenatal corticosteroid therapy	At the end of the study, an average of 2 month
Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the severity of intraventricular hemorrhage	Stage of intraventricular hemorrhage on transfontanellar ultrasound (FET) according to the number of doses of antenatal corticosteroid therapy : Stage 1 : Germline or subependymal hemorrhage (SEH), Stage 2 : Ventricular hemorrhage Stage 3 : Ventriculomegaly (VM) Stage 4 : Hemorrhage in the brain parenchyma	At the end of the study, an average of 2 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier René Dubos
• Investigators: Principal Investigator: Dr Suzanne BORRHOMEE, Centre Hospitalier Rene Dubos

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Corticosteroid therapy; Surfactants; Preterm infants
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Hyaline Membrane Disease; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: CHRD0822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No