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NCT Number: NCT02002741

Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

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Key information

Conditions

Ductus Arteriosus, Patent Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rambam Medical Center

Haifa, 31096, Israel

About this study

Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants born at 24-37 gestational age
  • diagnosis of Hemodynamically significant patent ductus arteriosus
  • Medical staff decided to treat with Ibuprofen
  • Parents have signed informed consent

Exclusion criteria

  • Contraindication for ibuprofen
  • Alanine transaminase /Aspartate transaminase≥ 200 U/L
  • Significant congenital heart disease

Treatment and study plan

Paracetamol

Drug

Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h

Other names: Acetaminophen, Acamol

Placebo

Drug

Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h

Other names: NaCl 0.9%

Primary outcomes

  1. The incidence of patent ductus arteriosus closure

    Time frame: 3-10 days after first dose of Ibuprofen + study drug

    By echocardiography

Secondary outcomes

  1. Adverse effects

    Time frame: until discharge home (usually within 2-3 months since recruitment)

    Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records

  2. The need for surgical ligation for PDA

    Time frame: 3-21 days after first dose of Ibuprofen + study drug

    need for surgical ligation for PDA

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2013
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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