Growth RetardationNCT05640596
Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
An observational study of Growth Retardation, run by Central Hospital, Nancy, France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Growth Retardation
- What is being tested?
- Betamethasone
- Type of treatment
- Injection or infusion
- How many people
- 363 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 25 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- Child
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.
Who may be able to join
- all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea because of a threat of premature delivery
- only full-term newborns
Who cannot join
- all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea for other reasons
About this study
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.
Read the 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.
- Conditions
- Growth Retardation
- Being tested
- Betamethasone
- Keywords
- Antenatal corticosteroid therapy, newborn, growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| exposed group (121 patients) | Extrated from the population of full-term newborns (> 36 weeks of amenorrhea + 6 days) between 2014 and 2020 at the Regional Maternity Hospital of Nancy who received at least one course of betamethasone before 34 weeks of amenorrhea for a threat of preterm delivery.
Exposure to an antenatal corticosteroid therapy was defined as the administration of at least one course of betamethasone (i.e. two doses of 12 mg, 24 hours apart). in intramuscular, before 34 weeks of amenorrhea, for a threat of premature delivery. Receives: Drug: Betamethasone | |
| nonexposed group (242 patients) | came from the population of full-term newborns (> 36 weeks of amenorrhea + 6 days) between 2014 and 2020 at the Regional Maternity Hospital of Nancy who who had not been exposed to antenatal steroid therapy. Two controls were selected for a case, appaired on the month and year of birth and on the sex of the case patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of an antenatal corticosteroid therapy on head growth.
head circumference
Measured: Birth
Secondary outcomes (7)
Evaluate the impact of an antenatal corticosteroid therapy on fetal weight
birth weight
Measured: Birth
Evaluate the impact of an antenatal corticosteroid therapy on fetal growth
birth lenght
Measured: birth
Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient
APGAR score
Measured: birth
Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia
hypoglycemia
Measured: first 5 days
Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia
hypocalcemia
Measured: first 5 days
Evaluate the impact of an antenatal corticosteroid therapy on neonatal outcome : number of days of hospitalisation after birth
day of hospitalisations after birth
Measured: first 5 days
Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink)
eating disorders
Measured: first 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jan 2014
- Primary completion31 Dec 2020
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RENARD Emeline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640596
- Sponsor's protocol ID
- 2021PI166
- Status last verified
- Dec 2022
- First submitted
- 12 Jul 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
Publications
Best C, Hascoet JM, Jeanbert E, Morel O, Baumann C, Renard E. Impact of corticosteroid exposure on preterm labor in neonates eventually born at term. J Perinatol. 2024 Feb;44(2):195-202. doi: 10.1038/s41372-023-01831-0. Epub 2023 Dec 1.
PubMed 38040875
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
- ClinicalTrials.gov ID
- NCT05640596
- Acronym / sponsor ID
- 2021PI166
- Conditions
- Growth Retardation
- Keywords
- Antenatal corticosteroid therapy, newborn, growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group (121 patients) | – | Drug: BetamethasoneExtrated from the population of full-term newborns (> 36 weeks of amenorrhea + 6 days) between 2014 and 2020 at the Regional Maternity Hospital of Nancy who received at least one course of betamethasone before 34 weeks of amenorrhea for a threat of preterm delivery. Exposure to an antenatal corticosteroid therapy was defined as the administration of at least one course of betamethasone (i.e. two doses of 12 mg, 24 hours apart). in intramuscular, before 34 weeks of amenorrhea, for a threat of premature delivery. |
| nonexposed group (242 patients) | – | –came from the population of full-term newborns (> 36 weeks of amenorrhea + 6 days) between 2014 and 2020 at the Regional Maternity Hospital of Nancy who who had not been exposed to antenatal steroid therapy. Two controls were selected for a case, appaired on the month and year of birth and on the sex of the case patient. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea because of a threat of premature delivery
- only full-term newborns
Key exclusion criteria (1 listed)
- all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea for other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethasone | Drug | exposed group (121 patients) |
Primary outcome
Evaluate the impact of an antenatal corticosteroid therapy on head growth.
Time frame: Birth
head circumference
7 secondary outcomes
Evaluate the impact of an antenatal corticosteroid therapy on fetal weight
Time frame: Birth
Evaluate the impact of an antenatal corticosteroid therapy on fetal growth
Time frame: birth
Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient
Time frame: birth
Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia
Time frame: first 5 days
Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia
Time frame: first 5 days
Evaluate the impact of an antenatal corticosteroid therapy on neonatal outcome : number of days of hospitalisation after birth
Time frame: first 5 days
Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink)
Time frame: first 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Derived from this study: PubMed 38040875Best C, Hascoet JM, Jeanbert E, Morel O, Baumann C, Renard E. Impact of corticosteroid exposure on preterm labor in neonates eventually born at term. J Perinatol. 2024 Feb;44(2):195-202. doi: 10.1038/s41372-023-01831-0. Epub 2023 Dec 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Retardation, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of an antenatal corticosteroid therapy on head growth. (time frame: Birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05640596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.