Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

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Brief Title

Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

Official Title

Randomised Controlled Clinical Trial of Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus: a Pilot Study

Brief Summary

      Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it
      has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA
      treatment according to the last version of the Cochrane review. Nowadays the best dose
      regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized
      controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen
      treatment versus standard treatment could reduce the number of doses of ibuprofen without
      increasing the reopening rate and reducing the side effects associated to this medication.
    

Detailed Description

      Patent ductus arteriosus (PDA) is presented in 55 to 70% of the preterm infants with a
      gestational age lower than 30 weeks or a birth weight lower than 1000 grams. PDA has being
      associated to mortality or morbidity such as ischemic or hemorrhagic cerebral events,
      necrotising enterocolitis, renal disfunction or poor pulmonary outcome; however, it is not
      clear whether these are a consequence of the PDA presence, the treatment implemented for
      closing it, or the immaturity of these population. PDA standard treatment (ST) consists on
      three doses of indomethacin or ibuprofen (10-5-5mg/kg) given 24 hours apart, being the
      surgical closure a second line therapeutic option. In spite of ibuprofen has been pointed as
      the drug of choice for PDA treatment by the last version of the Cochrane review, side effects
      have been associated to both medication. Standard ibuprofen treatment is based on a clinical
      trial where the three-dose protocol seemed to be more effective than one-dose scheme for PDA
      closure; however, the sample size was not powered to find differences statistically
      significant, so nowadays the best dose regimen for ibuprofen remains uncertain. Functional
      echocardiographic assessment is spreading to all over the world. In this scenario, it has
      been proposed its implementation to guide PDA treatment in order to individualize the number
      of doses of indomethacin administered as a function of patient's response, limiting the doses
      and side effects in those where PDA presented an early constriction. The investigators
      hypothesized whether echocardiographically guided PDA ibuprofen treatment could reduce the
      number of doses of ibuprofen without increasing the reopening rate and reducing the side
      effects associated to this medication.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

PDA re-opening rate

Secondary Outcome

 treatment failure

Condition

Patent Ductus Arteriosus

Intervention

Ibuprofen EchoG

Study Arms / Comparison Groups

 EchoG
Description:  Infants in the experimental group (echoG treatment) received additional doses of ibuprofen only if PDA was still ≥ 1.5 mm at the time of the corresponding ibuprofen dose.

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

49

Start Date

May 2009

Completion Date

March 2010

Primary Completion Date

March 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Preterm infants with a gestational age lower than 37 weeks of gestational age

          -  PDA ≥ 1.5 mm

          -  No contraindication to receive ibuprofen

          -  Informed consent signed.

        Exclusion Criteria:

          -  Life-threatening congenital defects

          -  Congenital heart disease

          -  Contraindication for ibuprofen administration such as oligoanuria < 1cc/kg/h or recent
             severe intraventricular bleeding (IVH grade III) or creatinine serum level > 1.5 mg/dl
             or potential intestinal ischemia.

          -  Informed consent refused
      

Gender

All

Ages

N/A - 1 Month

Accepts Healthy Volunteers

No

Contacts

María Carmen Bravo, PhD MD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01593163

Organization ID

IbuEchoG


Responsible Party

Principal Investigator

Study Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz


Study Sponsor

María Carmen Bravo, PhD MD, Principal Investigator, Department of Neonatology, La Paz University Hospital


Verification Date

May 2012