Growth Retardation Clinical Trial
Official title:
Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
NCT number | NCT05640596 |
Other study ID # | 2021PI166 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2014 |
Est. completion date | November 25, 2022 |
Verified date | December 2022 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 363 |
Est. completion date | November 25, 2022 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 12 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the impact of an antenatal corticosteroid therapy on head growth. | head circumference | Birth | |
Secondary | Evaluate the impact of an antenatal corticosteroid therapy on fetal weight | birth weight | Birth | |
Secondary | Evaluate the impact of an antenatal corticosteroid therapy on fetal growth | birth lenght | birth | |
Secondary | Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient | APGAR score | birth | |
Secondary | Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia | hypoglycemia | first 5 days | |
Secondary | Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia | hypocalcemia | first 5 days | |
Secondary | Evaluate the impact of an antenatal corticosteroid therapy on neonatal outcome : number of days of hospitalisation after birth | day of hospitalisations after birth | first 5 days | |
Secondary | Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink) | eating disorders | first 5 days |
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