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
NCT ID: NCT04282941
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2017-02-20
2020-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Administration schedule B: slow iv bolus Ibuprofen and EchoG. Each cycle will be 3 doses.
TREATMENT
DOUBLE
The doctors responsible for the patient will be blind to the intervention but will be responsible for the sealed envelopes, and at the time of patient randomization, will deliver the sealed envelope corresponding to the nurses responsible for the preparation of the medication.
Study Groups
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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.
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.
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
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* DA ≥ 1.5 mm with decision to start pharmacological treatment
* Informed consent signed by the legal representative
Exclusion Criteria
* 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.
0 Minutes
33 Weeks
ALL
No
Sponsors
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Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Locations
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Hospital Universitario La Paz
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Quirón Salud Madrid
Madrid, , Spain
Countries
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Facility Contacts
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Other Identifiers
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2016-002974-11
Identifier Type: -
Identifier Source: org_study_id