Clinical trial NCT05455879: Impact of Antenatal Corticosteroid Therapy on Postnatal Surfactant Use in Preterm Infants
Official title: Impact of the Number of Doses of Antenatal Corticosteroid Therapy on the Number of Doses of Surfactants Postnatal in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyaline Membrane Disease (HMD)
Keywords: Corticosteroid therapy
Surfactants
Preterm infants
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 145
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: At the end of the study, an average of 2 month
Secondary outcomes:
measure: Assessment of the influence of gestational age on the severity of hyaline membrane disease (HMD)
timeFrame: At the end of the study, an average of 2 month
measure: Assessment of the influence of the cause of prematurity on the severity of hyaline membrane disease (HMD)
timeFrame: At the end of the study, an average of 2 month
measure: Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the use of postnatal corticosteroid therapy
timeFrame: At the end of the study, an average of 2 month
measure: Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the prevalence of bronchopulmonary dysplasia
timeFrame: At the end of the study, an average of 2 month
measure: Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the severity of intraventricular hemorrhage
timeFrame: At the end of the study, an average of 2 month
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos
Study officials:
affiliation: Hôpital NOVO
name: Dr Suzanne BORRHOMEE
role: PRINCIPAL_INVESTIGATOR
References: