The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02602054|
Recruitment Status : Unknown
Verified November 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was: Recruiting
First Posted : November 11, 2015
Last Update Posted : November 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Persistent Ductus Arteriosus||Procedure: Surgical treatment Drug: Control group||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||October 2017|
Experimental: Surgical treatment
Implement surgical treatment for closure of patent ductus arteriosus
Procedure: Surgical treatment
Standard left thoracotomy
Other Name: Surgery
Active Comparator: Control group
- Indomethacin: Administer 1 full cycle (3 doses) of indomethacin (1 dose every 12 hours) for 2 days Dose 0.1 - 0.25 mg / kg
- Ibuprofen: Administer 1 full cycle (3 doses) of ibuprofen (1 dose every 24 hours) for 2 days Dose 05 - 10 mg / kg
- Acetaminophen: Administer 1 full cycle (12 doses) of acetaminophen (1 dose every 6 hours) for 3 days Dose 15 mg / kg
Drug: Control group
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
Administer 1 full cycle, in the first fourteen days of life in preterm infants:
Acetaminophen 15 mg/kg every 6 hours for 3 days
Other Name: Pharmacological
- 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 ) (%)
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602054
|Contact: Esaú Luis Nieto, Pediatricianemail@example.com|
|Hospital General Naval de Alta Especialidad||Recruiting|
|Distrito Federal, Mexico, 04477|
|Contact: Esaú Luis Nieto, Pediatrician 5564787736 firstname.lastname@example.org|
|Principal Investigator:||Esaú Luis Nieto, Pediatrician||Hospital General Naval de Alta Especialidad - Escuela Medico Naval|