- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282941
Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis (IBU24h-EchoG)
Phase III Clinical Trial, Randomized, Multicentre, Double Blind to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis
Persistent ductus arteriosus (DA) is a common entity in the premature newborn and is associated with high morbidity and mortality. There is still controversy about which is the best treatment for its closure. Children with AD who receive pharmacological treatment present more frequently than other premature children, necrotizing enterocolitis or isolated intestinal perforation.
At the present time, the conventional treatment of DA consists in the administration of intravenous ibuprofen, slow bolus in 3 daily doses 10-5-5 mg / kg / day. Recently, it has been observed that treatment with ibuprofen in continuous iv infusion for 3 days seems to be more effective in closing DA than conventional treatment for 3 days with the same dose but in slow iv bolus. This experimental treatment reduced the incidence of associated necrotizing enterocolitis. Our group demonstrated in a previous pilot trial that the guided treatment with echocardiography (EchoG) of DA with ibuprofen compared with conventional treatment, allows to reduce the number of doses to the patient. The EchoG treatment thus presents a potential reduction of side effects associated with medication, this resulted in a tendency to have a lower incidence of necrotising enterocolitis in the experimental group. This multicenter clinical trial aims to test the hypothesis that the combination of 2 experimental treatments, the use of ibuprofen in continuous perfusion and EchoG, reduces the incidence of digestive side effects (necrotising enterocolitis or isolated intestinal perforation) compared to the treatment also guided by echocardiography but slow bolus iv.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Contact:
- Maria Carmen Bravo Laguna, Dr.
- Phone Number: +34917277416
- Email: mcarmen.bravo@salud.madrid.org
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Contact:
- Paloma Moraga Alapont
- Email: paloma.ucicec@gmail.com
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Madrid, Spain
- Recruiting
- Hospital 12 de Octubre
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Contact:
- Fernando Cabañas
- Phone Number: 913 90 80 00
- Email: fernando.cabanas@quironsalud.es
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Madrid, Spain
- Recruiting
- Hospital Quirón Salud Madrid
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Contact:
- Fernando Cabañas
- Phone Number: 914 52 19 00
- Email: fernando.cabanas@quironsalud.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Preterm infants with less 33 weeks of gestational age
- DA ≥ 1.5 mm with decision to start pharmacological treatment
- Informed consent signed by the legal representative
Exclusion Criteria:
- Consent denied
- Presence of serious congenital alterations
- Congenital heart disease
- Contraindication for the administration of IB: oligoanuria (diuresis <1cc / kg / h), bleeding severe recent intraventricular (HIV grade III or extensive periventricular hemorrhagic infarction), serum creatinine> 1.5 mg / dl or clinical suspicion of intestinal ischemia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ibuprofen in continuous (24 hours) iv infusion and EchoG
The first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours.
An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size).
Each dose will be administered as a 24-hour continuous infusion.
|
The first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours.
An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size).
Each dose will be administered as a 24-hour continuous infusion.
|
EXPERIMENTAL: IV bolus Ibuprofen slow (15 minutes) and EchoG
The first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes).
Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size).
Each dose will be administered in iv boluses in 15 minutes
|
The first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes).
Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size).
Each dose will be administered in iv boluses in 15 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses
Time Frame: 40 weeks
|
Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses
|
40 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Identify genetic polymorphisms asociated to refractory medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.
Time Frame: Day 0(Visit 1)
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Identify genetic polymorphisms in patients refractory to medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.
|
Day 0(Visit 1)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Assess the incidence of neonatal morbidity associated with each of the forms of treatment
Time Frame: up to 40 Weeks Postmenstrual age
|
Assess the incidence of neonatal morbidity associated with each of the forms of treatment
|
up to 40 Weeks Postmenstrual age
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To Assess the neonatal mortality associated with each of the forms of treatment
Time Frame: up to 40 Weeks Postmenstrual age
|
Assess the neonatal mortality associated with each of the forms of treatment
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up to 40 Weeks Postmenstrual age
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Ductus Arteriosus, Patent
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- 2016-002974-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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