Clinical trial NCT05640596: Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
Official title: Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Retardation
Keywords: Antenatal corticosteroid therapy
newborn
growth
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 363
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children included in the study were born at the Regional Maternity Hospital of Nancy between January 1, 2014 and December 31, 2020.

One hundred and twenty-one of them were exposed during pregnancy to antenatal corticosteroids therapy and constitute the exposed arm, whereas 242 were not and constitute the non-exposed arm.

Brief summary: Use of antenatal corticosteroids therapy has increased since the 2000s. The benefits of such a therapy on premature newborns are scientifically and internationally recognized.

Nevertheless, few studies have been conducted to investigate the impact of this antenatal corticosteroid therapy on full-term newborns (\> 36 weeks' gestation).

The aim of this study is to compare the birth parameters of full-term newborns exposed or not to antenatal corticosteroid therapy.

Detailed description: All children included in the study were born at the Regional Maternity Hospital of Nancy between January 1, 2014 and December 31, 2020.

One hundred and twenty-one of them were exposed during pregnancy to antenatal corticosteroids therapy and constitute the exposed arm, whereas 242 were not and constitute the non-exposed arm.

Data were collected retrospectively regarding history of pregnancy, birth parameters and neonatal adaptation.

Eligibility criteria: Inclusion Criteria:

* all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea because of a threat of premature delivery
* only full-term newborns

Exclusion Criteria:

* all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea for other reasons

Primary outcomes:
measure: Evaluate the impact of an antenatal corticosteroid therapy on head growth.
timeFrame: Birth
Secondary outcomes:
measure: Evaluate the impact of an antenatal corticosteroid therapy on fetal weight
timeFrame: Birth
measure: Evaluate the impact of an antenatal corticosteroid therapy on fetal growth
timeFrame: birth
measure: Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient
timeFrame: birth
measure: Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia
timeFrame: first 5 days
measure: Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia
timeFrame: first 5 days
measure: Evaluate the impact of an antenatal corticosteroid therapy on neonatal outcome : number of days of hospitalisation after birth
timeFrame: first 5 days
measure: Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink)
timeFrame: first 5 days
Other outcomes:
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