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Completed

NCT Number: NCT05455879

Impact of Antenatal Corticosteroid Therapy on Postnatal Surfactant Use 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.

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Key information

Conditions

Hyaline Membrane Disease (HMD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyaline Membrane Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases

Age range

Up to 37 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos

Pontoise, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Impact of antenatal corticosteroid therapy on surfactants use postnatal

Other

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

Primary outcomes

  1. 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.

    Time frame: At the end of the study, an average of 2 month

    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

Secondary outcomes

  1. Assessment of the influence of gestational age on the severity of hyaline membrane disease (HMD)

    Time frame: At the end of the study, an average of 2 month

    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

  2. Assessment of the influence of the cause of prematurity on the severity of hyaline membrane disease (HMD)

    Time frame: At the end of the study, an average of 2 month

    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

  3. Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the use of postnatal corticosteroid therapy

    Time frame: At the end of the study, an average of 2 month

    Prevalence of postnatal corticosteroid therapy by number of doses of antenatal corticosteroid therapy

  4. Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the prevalence of bronchopulmonary dysplasia

    Time frame: At the end of the study, an average of 2 month

    Prevalence of bronchopulmonary dysplasia as a function of the number of doses of antenatal corticosteroid therapy

  5. Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the severity of intraventricular hemorrhage

    Time frame: At the end of the study, an average of 2 month

    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

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: CORISURF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Sep 19, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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