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

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Brief Title

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

Official Title

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

Brief Summary

      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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 To Identify genetic polymorphisms asociated to refractory medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.

Condition

Persistent Ductus Arteriosus

Intervention

Ibuprofen in continuous (24 hours) iv infusion and EchoG

Study Arms / Comparison Groups

 Ibuprofen in continuous (24 hours) iv infusion and EchoG
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

180

Start Date

February 20, 2017

Completion Date

November 30, 2020

Primary Completion Date

January 30, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 33 Weeks

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT04282941

Organization ID

2016-002974-11


Responsible Party

Sponsor

Study Sponsor

Instituto de Investigación Hospital Universitario La Paz


Study Sponsor

, , 


Verification Date

June 2019