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