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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 contraindication
Sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Current Primary Outcome: Success rate of closure patent ductus arteriosus [ Time Frame: 10 days after treatment ]

Tracking each patient for 10 days after treatment (surgical / pharmacological) to verify success rate of closure of patent ductus arteriosus (Failure of ductal closure ) (%)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time from diagnosis to resolution of patent ductus arteriosus [ Time Frame: 1 month ]
    To compare the time from diagnosis to resolution of patent ductus arteriosus (days)
  • Time from start of treatment until resolution [ Time Frame: 10 days after treatment ]
    To compare the time from start of treatment until resolution of patent ductus arteriosus (days)
  • Time limitation of family contact [ Time Frame: 1 month ]
    To compare the time limitation of family contact from diagnosis to hospital discharge of newborns of patent ductus arteriosus (days)
  • Adverse effects and complications of treatment [ Time Frame: 10 days ]
    Describe the type of adverse effects and / or complications (Chronic lung disease , Intraventricular haemorrhage, Creatinine level > 1.8 mg/dl, Pneumothorax , Sepsis, Necrotising enterocolitis, Retinopathy of prematurity, Other bleeding) and the frequency of the two study groups (yes / no)
  • Death before discharge [ Time Frame: 1 month ]
    To compare related mortality among surgical and pharmacological treatment (%)
  • Time of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2 [ Time Frame: 1 month ]
    To compare the duration of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2 (days).
  • Anatomy of the ductus arteriosus persistent [ Time Frame: 1 month ]
    Describe the size of the ductus arteriosus (mm)
  • Gestational age at birth [ Time Frame: At birth ]
    Describe the gestational age of neonates (weeks)
  • Apgar [ Time Frame: At birth ]
    Describe the Apgar score of newborns (3-9)
  • Blood flow [ Time Frame: 1 month ]
    Describe the direction of blood flow of the ductus arteriosus (left-right, left-right, two-way)
  • Gradient of the ductus arteriosus [ Time Frame: 1 month ]
    Describe the gradient of the ductus arteriosus (mmHg).


Original Secondary Outcome: Same as current

Information By: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Dates:
Date Received: November 8, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: November 16, 2015
Last Verified: November 2015