Clinical trial NCT02602054: The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants
Official title: The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Persistent Ductus Arteriosus
Keywords: persistent ductus arteriosus
preterm infants
surgical treatment
pharmacological treatment
Lead sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Sponsor class: OTHER_GOV
First posted: 2015-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants
* Preterm infants hospitalized in the Neonatal Intensive Care Unit with a diagnosis of patent ductus arteriosus

Exclusion Criteria:

* Preterm infants with supportive treatment and / or drug prior to patent ductus arteriosus in another medical unit
* Preterm infants diagnosed with heart disease associated complex.
* Preterm infants with associated disease (not hemodynamic or cardiovascular) and its impact on his state of health prior to drug treatment and / or surgery
* Preterm infants with contraindications to pharmacological and / or surgery treatment
* Newborns diagnosed with patent ductus arteriosus but with incomplete medical records

Primary outcomes:
measure: Success rate of closure patent ductus arteriosus
timeFrame: 10 days after treatment
Secondary outcomes:
measure: Time from diagnosis to resolution of patent ductus arteriosus
timeFrame: 1 month
measure: Time from start of treatment until resolution
timeFrame: 10 days after treatment
measure: Time limitation of family contact
timeFrame: 1 month
measure: Adverse effects and complications of treatment
timeFrame: 10 days
measure: Death before discharge
timeFrame: 1 month
measure: Time of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2
timeFrame: 1 month
measure: Anatomy of the ductus arteriosus persistent
timeFrame: 1 month
measure: Gestational age at birth
timeFrame: At birth
measure: Apgar
timeFrame: At birth
measure: Blood flow
timeFrame: 1 month
measure: Gradient of the ductus arteriosus
timeFrame: 1 month
Other outcomes:
Locations:
city: Distrito Federal
country: Mexico
facility: Hospital General Naval de Alta Especialidad
Study officials:
affiliation: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
name: Esaú Luis Nieto, Pediatrician
role: PRINCIPAL_INVESTIGATOR
References:
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