An observational study in Persistent Ductus Arteriosus, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Hospices Civils de Lyon · Observational
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
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's planned enrollment of 51 is below the median of 100 across 52 observational studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Infants born between january 2018 and December 2022, at a gestational age below 37 weeks, hospitalized in the Neonatal unit of Croix-Rousse hospital, presenting an hemodynamically significant DA and treated by BTM for bronchopulmonary dysplasia
born between January 2018 and December 2022
Children having closed their ductus arteriosus before administration of the betamethasone course
All infants born alive before 37 weeks between January 1st, 2018 and December 31st, 2022 with PDA
Other: DA closure in a population of premature infants
Evaluate the incidence of DA closure in a population of premature infants treated with BTM per os for bronchopulmonary dysplasia
Number of children with favorable evolution of the CAP
Number of children with favorable evolution of the CAP Percentage of children who present a favorable evolution of the CAP defined as a closure of the CAP or a CAP which becomes hemodynamically insignificant, under the effect of treatment with BTM
Time frame: through study completion, an average of 6 months
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