NCT02602054

The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants

The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Other Government
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Ductus Arteriosus

Interventions

Type	Name	Description
PROCEDURE	Surgical treatment	Standard left thoracotomy
DRUG	Control group	\- Indomethacin: Administer 1 full cycle (3 doses) / (1 dose every 12 hours) in the first fourteen days of life: Preterm infants less than 48 hours of life: first dose 0.2 mg/kg, second dose 0.1 mg/kg and third dose 0.1 mg/kg Preterm infants more than 48 hours of life: first dose 0.2 mg/kg, second dose 0.2 mg/kg and third dose 0.2 mg/kg And preterm infants more than 7 days of life: first dose 0.2 mg/kg, second dose 0.25 mg/kg and third dose 0.25 mg/kg - Ibuprofen: Administer 1 full cycle (3 doses) / (1 dose every 24 hours) in the first fourteen days of life of preterm infants: First dose 10 mg/kg Second dose 05 mg/kg Third dose 05 mg/kg \- Acetaminophen Administer 1 full cycle, in the first fourteen days of life in preterm infants: Acetaminophen 15 mg/kg every 6 hours for 3 days

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-04-01
• Completion: 2017-10-01
• First posted: 2015-11-11
• Last updated: 2015-11-17

Locations

1 site across 1 country: Mexico