Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05987202
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-08-02
Brief Title:
Betamethasone and Closure of Ductus Arteriosus
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Impact of Postnatal Betamethasone Treatment on Closure of Ductus Arteriosus in Preterm Infants
Status:
RECRUITING
Status Verified Date:
2024-01
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:
CELESTE
Brief Summary:
The ductus arteriosus DA normally closes after birth as a result of exposure to oxygen Its persistence of DA PDA occurs in 20 to 50 of very preterm infants and is associated with significant morbidity and mortality prolongation of respiratory assistance pulmonary haemorrhage -necrotizing enterocolitis NECU intraventricular haemorrhage and death
PDA management is one of the most discussed aspects in neonatology The treatment is either conservative controlled fluid intake monitoring of cerebral flows diuretics or pharmacological ibuprofen or paracetamol per os or surgical thoracotomy ligature or catheterization plug The success rate of pharmacological treatment of CAP is 30 in the most immature children When medical treatment fails surgical or endovascular treatment is considered However these are associated with complications such as recurrent nerve lesion thoracotomy failure to close DA migration of the plug Therefore individualized assessment balances the expected benefits of CAP treatment against the risks associated with the treatments for each patient
The main complication of CAP is the impossibility of weaning the patient from ventilatory assistance On the one hand because of PDA but also very often because of the concomitant development of bronchopulmonary dysplasia BPD due to pulmonary lesions secondary to assisted ventilation and especially to inflammation At 3 weeks of life if attempts at ventilatory weaning have failed postnatal corticosteroid therapy is considered in the 4th week of life in accordance with current recommendations
The most commonly used postnatal corticosteroids are dexamethasone DXM hydrocortisone hemisuccinate HSHC and betamethasone BTM DXM intravenous is effective and is the most widely used product worldwide but its use is associated with impaired postnatal growth and suboptimal neurodevelopment HSHC intravenous is an alternative to DXM and has shown some effectiveness without the adverse effects of DXM The BTM is also an alternative but has been used less than the other products because it is not widely available in some countries Its advantage is that it can be given orally but there is little published data on the effect of BTM In this context it has been used in some neonatal units and have shown some effectiveness
In the Neonatology department of the Croix Rousse hospital oral BTM has been used since 2005 and has been evaluated favorably since it allows the child to be weaned from ventilatory assistance When using BTM we observed not only a positive respiratory effect but also DA closure reducing the need for ligation of the ductus arteriosus by surgery or catheterization
PDA management is one of the most discussed aspects in neonatology The treatment is either conservative controlled fluid intake monitoring of cerebral flows diuretics or pharmacological ibuprofen or paracetamol per os or surgical thoracotomy ligature or catheterization plug The success rate of pharmacological treatment of CAP is 30 in the most immature children When medical treatment fails surgical or endovascular treatment is considered However these are associated with complications such as recurrent nerve lesion thoracotomy failure to close DA migration of the plug Therefore individualized assessment balances the expected benefits of CAP treatment against the risks associated with the treatments for each patient
The main complication of CAP is the impossibility of weaning the patient from ventilatory assistance On the one hand because of PDA but also very often because of the concomitant development of bronchopulmonary dysplasia BPD due to pulmonary lesions secondary to assisted ventilation and especially to inflammation At 3 weeks of life if attempts at ventilatory weaning have failed postnatal corticosteroid therapy is considered in the 4th week of life in accordance with current recommendations
The most commonly used postnatal corticosteroids are dexamethasone DXM hydrocortisone hemisuccinate HSHC and betamethasone BTM DXM intravenous is effective and is the most widely used product worldwide but its use is associated with impaired postnatal growth and suboptimal neurodevelopment HSHC intravenous is an alternative to DXM and has shown some effectiveness without the adverse effects of DXM The BTM is also an alternative but has been used less than the other products because it is not widely available in some countries Its advantage is that it can be given orally but there is little published data on the effect of BTM In this context it has been used in some neonatal units and have shown some effectiveness
In the Neonatology department of the Croix Rousse hospital oral BTM has been used since 2005 and has been evaluated favorably since it allows the child to be weaned from ventilatory assistance When using BTM we observed not only a positive respiratory effect but also DA closure reducing the need for ligation of the ductus arteriosus by surgery or catheterization
Detailed Description:
None
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