Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04021485
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2019-07-08
Brief Title:
BETAmethasone Dose Reduction Non-Inferiority on the Neurocognitive Outcomes of Children Born Before 32 Weeks of Gestation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
5-year Follow-up of the BETADOSE Trial Non-inferiority of a 50 Dose Reduction of Antenatal Betamethasone Therapy on the Neurodevelopment of Children Born Before 32 Weeks of Gestation
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BETANINO
Brief Summary:
Maternal antenatal corticosteroid therapy is the last major advance in the antenatal management of fetuses to prevent neonatal complications associated with prematurity Long-term neurological outcomes in infants exposed to antenatal steroids have been assessed in few cohorts and suggest that this therapy is able to prevent some neurodevelopmental impairments including cerebral palsy While 85 of neonates born very preterm in Europe have been exposed to antenatal betamethasone Cochrane collaborative networks stated that trials of dosages comparing different regimens of commonly used corticosteroids are most urgently needed to avoid useless fetal exposure to excessive dosage of corticosteroids
Because a half dosage was associated with maximal benefits on lung function in ewes a randomized controlled trial BETADOSE NCT02897076 has been conducted to demonstrate that a 50 reduced betamethasone dose regimen is not inferior to a full dose to prevent respiratory distress syndrome in preterm neonates BETADOSE trial demonstrated that half dose did not show noninferiority to full antenatal betamethasone dose regimen to prevent severe RDS in preterm neonates while other prematurity-associated complications including those usually prevented by ACS did not differ between the two groups
Results of the 5-year BETANINO follow-up study of the BETADOSE neonates are needed before deciding whether reducing ACS dose is possible The main hypothesis of BETANINO is that half dose regimen of betamethasone is not inferior to full dose regimen of betamethasone to prevent neurodevelopmental impairments in these high-risk children born very preterm at 5 years of age
Because a half dosage was associated with maximal benefits on lung function in ewes a randomized controlled trial BETADOSE NCT02897076 has been conducted to demonstrate that a 50 reduced betamethasone dose regimen is not inferior to a full dose to prevent respiratory distress syndrome in preterm neonates BETADOSE trial demonstrated that half dose did not show noninferiority to full antenatal betamethasone dose regimen to prevent severe RDS in preterm neonates while other prematurity-associated complications including those usually prevented by ACS did not differ between the two groups
Results of the 5-year BETANINO follow-up study of the BETADOSE neonates are needed before deciding whether reducing ACS dose is possible The main hypothesis of BETANINO is that half dose regimen of betamethasone is not inferior to full dose regimen of betamethasone to prevent neurodevelopmental impairments in these high-risk children born very preterm at 5 years of age
Detailed Description:
Maternal antenatal corticosteroids ACS therapy is considered to be the last major advance in the antenatal management of fetuses at risk of preterm birth It was adopted worldwide to prevent neonatal death and neonatal complications following preterm birth including respiratory distress syndrome necrotizing enterocolitis and severe intraventricular hemorrhage While short-term benefits of ACS were extensively investigated long-term neurological outcomes in infants exposed antenatally to betamethasone have been assessed in few cohorts only A recent report from the Cochrane collaborative network suggest that ACS is able to prevent some neurodevelopmental impairments associated with preterm delivery and related to postnatal adverse events
As of today in Europe and France more than 85 of neonates born very preterm have been exposed to antenatal corticosteroids mostly betamethasone for a total dose of 24 mg Cochrane collaborative networks stated that trials of dosages comparing different regimens of commonly used corticosteroids are most urgently needed Because a half dosage was associated with maximal benefits on lung function in ewes a randomized controlled trial BETADOSE NCT02897076 is currently conducted to demonstrate that a 50 reduced betamethasone dose regimen is not inferior to a full dose regimen to prevent respiratory distress syndrome in neonates Whatever the results of this ongoing clinical trial follow-up of infants born from enrolled women is mandatory both to confirm the non-inferiority of the dose reduction on neurocognition and to assess the long-term effect of dose reduction on survival on complex aspects of cognition on behavioral aspects and on others neurodevelopmental impairments Indeed changes in clinical practices following BETADOSE trials will be depending on both short- and long-term outcomes If non inferiority is demonstrated dramatic changes will occur in the clinical use of antenatal betamethasone in women at risk of preterm birth in France and worldwide If non inferiority is rejected the neurocognitive follow-up of enrolled patients will be also of interest to i assess the long-term impact of the early consequences associated with betamethasone dose reduction and ii to find out domains of neurocognitive development sensitive to ACS exposure
BETANINO study aims at assessing the impact of a 50 dose reduction on neurocognition at 5 years of age in infants born from mothers enrolled in the BETADOSE trial before 32 weeks of gestation children that are at highest risk of neurocognitive impairments during childhood
The main hypothesis of this cohort study following a randomized clinical trial is that half dose betamethasone 12 mg is not inferior to full dose betamethasone 24 mg to prevent neurodevelopmental impairment in children born very preterm
As of today in Europe and France more than 85 of neonates born very preterm have been exposed to antenatal corticosteroids mostly betamethasone for a total dose of 24 mg Cochrane collaborative networks stated that trials of dosages comparing different regimens of commonly used corticosteroids are most urgently needed Because a half dosage was associated with maximal benefits on lung function in ewes a randomized controlled trial BETADOSE NCT02897076 is currently conducted to demonstrate that a 50 reduced betamethasone dose regimen is not inferior to a full dose regimen to prevent respiratory distress syndrome in neonates Whatever the results of this ongoing clinical trial follow-up of infants born from enrolled women is mandatory both to confirm the non-inferiority of the dose reduction on neurocognition and to assess the long-term effect of dose reduction on survival on complex aspects of cognition on behavioral aspects and on others neurodevelopmental impairments Indeed changes in clinical practices following BETADOSE trials will be depending on both short- and long-term outcomes If non inferiority is demonstrated dramatic changes will occur in the clinical use of antenatal betamethasone in women at risk of preterm birth in France and worldwide If non inferiority is rejected the neurocognitive follow-up of enrolled patients will be also of interest to i assess the long-term impact of the early consequences associated with betamethasone dose reduction and ii to find out domains of neurocognitive development sensitive to ACS exposure
BETANINO study aims at assessing the impact of a 50 dose reduction on neurocognition at 5 years of age in infants born from mothers enrolled in the BETADOSE trial before 32 weeks of gestation children that are at highest risk of neurocognitive impairments during childhood
The main hypothesis of this cohort study following a randomized clinical trial is that half dose betamethasone 12 mg is not inferior to full dose betamethasone 24 mg to prevent neurodevelopmental impairment in children born very preterm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None