Persistent Ductus Arteriosus Clinical Trial
Official title:
The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial
The decision to treat patent ductus arteriosus in preterm infants, varies from a conservative, medical or immediate surgical treatment; although, at present, there is some controversy about this decision. This study aims to determine the efficacy and safety of surgical versus pharmacological treatment of patent ductus arteriosus in preterm infants.
The ductus arteriosus varies in length, diameter and morphology. The duct closure occurs in
two stages: the first one or functional closure; the second or anatomical closure. This
condition is associated with other heart diseases, which modify the natural history and
require individualized treatment. Treatment varies from conservative, pharmacological or
surgical treatment, and there are many controversies regarding the treatment decision. And
aims of the closure, is to decrease the likelihood of irreversible pulmonary vascular
disease, reduce associated morbidity and mortality. The role of prostaglandin E2 is the
permeability of the conduit, by which is indicated the use of cyclooxygenase inhibitors for
closure (indomethacin and ibuprofen). In various research studies many factors associated
with failure of pharmacological treatment (gestational age, antenatal indomethacin less than
48 hours before delivery, use of high frequency ventilation) are reported, therefore, there
is an alternative treatment which is surgical closure. In the pharmacological treatment of
ductus arteriosus persistent it should be individualized according to gestational age,
respiratory condition and size of the newborn. With early drug treatment can achieve closure
of patent ductus arteriosus in up to 90% of cases, while the late treatment between 50-65%.
However, it is reported that after treatment with indomethacin, reopening occurs, two doses
are recommended more after the first, in addition to its side effects, contraindications and
complications. As well, ibuprofen contraindications. So the closure of the ductus arteriosus
persistent may be performed by hemodynamics and surgical closure (standard left thoracotomy
or thoracoscopic technique). There are specific indications for surgical treatment (no
response to two cycles of medical treatment in newborns with less than 1000 gr weight in
which I fail one indomethacin, absolute contraindications to it, with significant
hemodynamic repercussions. With surgical treatment before the third week of life minimizing
morbidity. it is reported by many authors that complications are rare and mortality is
associated with other complications of prematurity. So Surgical treatment is considered as
an alternative because of its low incidence of complications, mortality and lower cost, plus
a total occlusion between 94-100% Because of this, the treatment of patent ductus arteriosus
in preterm infants, ranging from conservative treatment, medical or surgical, and currently
there is much controversy in the treatment decision.
This study aims to determine the efficacy and safety of surgical versus pharmacological
treatment for the permanent closure of the patent ductus arteriosus in preterm infants.
Methods: Is open label randomized controlled the clinical trial with: 1) experimental group
assigned to surgical treatment; 2) control group assigned to pharmacological treatment, for
closure of patent ductus arteriosus.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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