Clinical trial to evaluate the impact on the intestinal prognosis of 2 ibuprofen administration regimens for the treatment of patent ductus arteriosus, guided by echocardiography

Phase III, randomized, multicenter, double-blind clinical trial to evaluate two echo-guided administration regimens of ibuprofen in the treatment of patent ductus arteriosus: impact on intestinal prognosis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002974-11-ES

Enrollment

Unknown

Registered

2016-09-26

Start date

2016-11-10

Completion date

Unknown

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patent ductus arteriosus MedDRA version: 19.0 Level: PT Classification code 10034130 Term: Patent ductus arteriosus System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Pedea Product Name: Echo-guided ibuprofen Pharmaceutical Form: Solution for injection INN or Proposed INN: IBUPROFEN Other descriptive name: Ibuprofeno Concentration unit: mg/ml milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Preterm infants less than 33 weeks gestational age 2. PDA = 1.5 mm and medical decision to start drug treatment 3. Signed informed consent by the legal representative Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Consent Denied 2. Presence of severe birth defects 3. Congenital Heart Disease 4. Contraindication for administration of IB: • oligoanuria (diuresis 1.5 mg / dl or clinical suspicion of intestinal ischemia.

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduce the incidence of NEC or AIP in preterm infants receiving treatment for closure of PDA with EchoG continuous IV infusion Iv EchoG IV. bolus of IB;Secondary Objective: Identify genetic polymorphisms in patients refractory to medical treatment of PDA and those most vulnerable to develop ECN or AIP. Exploratory Objectives: To evaluate the incidence of neonatal morbidity and mortality associated with each way of treatment;Primary end point(s): Incidence of NEC or API, defined as the presence of intestinal pneumatosis, pneumoperitoneum, or air in portal vein;Timepoint(s) of evaluation of this end point: Time of discharge of Neonatology Department or at completed 40 weeks post-menstrual age (whichever comes first)	—

Measure

Time frame

Main Objective: Reduce the incidence of NEC or AIP in preterm infants receiving treatment for closure of PDA with EchoG continuous IV infusion Iv EchoG IV. bolus of IB;Secondary Objective: Identify genetic polymorphisms in patients refractory to medical treatment of PDA and those most vulnerable to develop ECN or AIP. Exploratory Objectives: To evaluate the incidence of neonatal morbidity and mortality associated with each way of treatment;Primary end point(s): Incidence of NEC or API, defined as the presence of intestinal pneumatosis, pneumoperitoneum, or air in portal vein;Timepoint(s) of evaluation of this end point: Time of discharge of Neonatology Department or at completed 40 weeks post-menstrual age (whichever comes first)

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Secondary

Measure	Time frame
Secondary end point(s): • Perinatal endpoints: o Mother's age o gestational age o maternal medication (antibiotics, anticonvulsants, antihypertensives, drugs of abuse, heparin, tocolytic, etc) o Birthweight o Sex o weight ( 18 hours o Advanced Resuscitation at birth o SNAPPE II o clinical chorioamnionitis o histologically confirmed Chorioamnionitis o cord pH o Multiple Pregnancy o Need surfactant Age of onset or treatment • echocardiographic endpoints: o Prior to treatment: ? ductus size color Doppler supraesternal in a sagittal cut. ? Relationship AI / Ao (left atrium / aorta) in a long axis parasternal M-mode ? diastolic velocity in the left pulmonary branch with a sagittal parasternal. ? ratio E / A (wave left ventricular filling) with an apical 4-chamber window. ? scFv (superior vena cava flow) measuring the size from a half left parasternal and speed from a subcostal window. ? postductal diastolic velocity in aorta from supraesternal court. • cardiorespiratory endpoints: o Prior to each dose: ? Heart Rate ? Blood Pressure ? Respiratory rate ? ventilation mode ? PMVA (mean airway pressure) ? FiO2 ? SatO2 ? capillary pCO2 ? arterial pCO2 ? venous pCO2 ? EB (Excess bases) Lactic acid ? ? diuresis 24 hours before treatment ? Capillary refill ? Gradient center-peripheral Tª ? cardiovascular support prior to treatment (blood volume expanders in previous 24 hours, prior to each dose inotropic score of treatment = (dopamine x 1) + (dobutamine x 1) + (adrenaline x 10) or need for hydrocortisone. • Efficacy endpoints: o treatment failure, defined as the presence of = 1.5 mm DA 24-48 hours after finishing a maximum of 6 doses of ibuprofen (2 full cycles). o number of doses administered ibuprofen. o closing rate after a treatment cycle o closing rate after two cycles of treatment. o time required until closing. o need for surgical ligation. o reopening rate: defined as the presence of ductal color Doppler flow after confirming previous close echocardiographic. • Genetic e	—

Measure

Time frame

Secondary end point(s): • Perinatal endpoints: o Mother's age o gestational age o maternal medication (antibiotics, anticonvulsants, antihypertensives, drugs of abuse, heparin, tocolytic, etc) o Birthweight o Sex o weight ( 18 hours o Advanced Resuscitation at birth o SNAPPE II o clinical chorioamnionitis o histologically confirmed Chorioamnionitis o cord pH o Multiple Pregnancy o Need surfactant Age of onset or treatment • echocardiographic endpoints: o Prior to treatment: ? ductus size color Doppler supraesternal in a sagittal cut. ? Relationship AI / Ao (left atrium / aorta) in a long axis parasternal M-mode ? diastolic velocity in the left pulmonary branch with a sagittal parasternal. ? ratio E / A (wave left ventricular filling) with an apical 4-chamber window. ? scFv (superior vena cava flow) measuring the size from a half left parasternal and speed from a subcostal window. ? postductal diastolic velocity in aorta from supraesternal court. • cardiorespiratory endpoints: o Prior to each dose: ? Heart Rate ? Blood Pressure ? Respiratory rate ? ventilation mode ? PMVA (mean airway pressure) ? FiO2 ? SatO2 ? capillary pCO2 ? arterial pCO2 ? venous pCO2 ? EB (Excess bases) Lactic acid ? ? diuresis 24 hours before treatment ? Capillary refill ? Gradient center-peripheral Tª ? cardiovascular support prior to treatment (blood volume expanders in previous 24 hours, prior to each dose inotropic score of treatment = (dopamine x 1) + (dobutamine x 1) + (adrenaline x 10) or need for hydrocortisone. • Efficacy endpoints: o treatment failure, defined as the presence of = 1.5 mm DA 24-48 hours after finishing a maximum of 6 doses of ibuprofen (2 full cycles). o number of doses administered ibuprofen. o closing rate after a treatment cycle o closing rate after two cycles of treatment. o time required until closing. o need for surgical ligation. o reopening rate: defined as the presence of ductal color Doppler flow after confirming previous close echocardiographic. • Genetic e

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Countries

Spain

Contacts

Public ContactUCICEC

Hospital Universitario La Paz

herranz.estelles@gmail.com003491 2071466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026