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Paracetamol (acetaminophen) for patent ductus arteriosus in preterm and/or low-birth-weight infants

  • Protocol
  • Intervention

Authors

  • Arne Ohlsson,

    Corresponding author
    1. University of Toronto, Departments of Paediatrics, Obstetrics and Gynaecology and Institute of Health Policy, Management and Evaluation, Toronto, Ontario, Canada
    • Arne Ohlsson, Departments of Paediatrics, Obstetrics and Gynaecology and Institute of Health Policy, Management and Evaluation, University of Toronto, 600 University Avenue, Toronto, Ontario, M5G 1X5, Canada. aohlsson@mtsinai.on.ca.

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  • Prakeshkumar S Shah

    1. University of Toronto, Department of Paediatrics and Department of Health Policy, Management and Evaluation, Rm 775A, Toronto, Ontario, Canada
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Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

Primary objectives

  1. To determine the efficacy and safety of iv or oral paracetamol compared with placebo or no intervention for closure of a PDA in preterm and/or low birth weight infants.

  2. To determine the efficacy and safety of iv or oral paracetamol compared with iv indomethacin, for closure of a PDA in preterm and/or low birth weight infants.

  3. To determine the efficacy and safety of iv or oral paracetamol compared with iv ibuprofen for closure of a PDA in preterm and/or low birth weight infants.

  4. To determine the efficacy and safety of iv or oral paracetamol compared with oral ibuprofen for closure of a PDA in preterm and/or low birth weight infants.

  5. To determine the efficacy and safety of iv or oral paracetamol compared with other cyclo-oxygenase inhibitors (separate analyses for different cyclo-oxygenase inhibitors) for closure of a PDA in preterm and/or low birth weight infants.

Secondary objectives

  1. To determine in subgroup analyses the efficacy and safety of paracetamol for closure of a PDA in relation to postnatal ages of < seven days, seven to 14 days and > 14 days at the time of administration of the first dose of paracetamol.

  2. To determine in subgroup analyses the efficacy and safety of paracetamol for closure of a PDA in relation to the following criteria:

    1. gestational age (< 28 weeks, 28 to 32 weeks, 33 to 36 weeks);

    2. birth weight (< 1000 g, 1000 to 1500 g, 1501 to 2500 g).

  1. gestational age (< 28 weeks, 28 to 32 weeks, 33 to 36 weeks);

  2. birth weight (< 1000 g, 1000 to 1500 g, 1501 to 2500 g).