Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

Last updated: October 16, 2024
Sponsor: University of Oulu
Overall Status: Terminated

Phase

1

Condition

Heart Defect

Treatment

0.45% Sodium Chloride

Paracetamol 10Mg/mL

Indomethacin

Clinical Study ID

NCT03648437
38/2018
  • Ages < 4
  • All Genders

Study Summary

The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, multicenter, clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Preterm infants (born before 37+0 gestation weeks) who are diagnosed to have ahemodynamically significant PDA and who, according to the decision of the attendingclinician, need ibuprofen therapy, are eligible to this trial.

Exclusion

Exclusion Criteria:

  • severe malformation or suspected chromosomal defect

  • other very severe life-threatening disease (e.g. very severe birth asphyxia orpersistent pulmonary hypertension, etc.)

Study Design

Total Participants: 22
Treatment Group(s): 4
Primary Treatment: 0.45% Sodium Chloride
Phase: 1
Study Start date:
September 03, 2018
Estimated Completion Date:
October 04, 2024

Study Description

Premature infants (born before 37 weeks gestational age) with patent ductus arteriosus (PDA) are the focus of the study since no trials on the additive efficacy of these two medications on the contraction of ductus arteriosus are available. Preterm infants who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen/indomethacin therapy, are eligible to this trial.

If the parents deny the consent, the patient will be treated according to the standard PDA treatment: three days' iv ibuprofen Pedea® 5mg/ml solution infusion (Oulu, Helsinki, Tartu) dosing: 10mg/kg + 5mg/kg + 5mg/kg (q24h); or three days' iv indomethacin (Turku) 0.2mg/kg + 0.1mg/kg + 0.1mg/kg (q24h). In case of any contraindications for ibuprofen/indomethacin, the treatment would be surgical ligation.

Connect with a study center

  • Tartu University Hospital

    Tartu,
    Estonia

    Site Not Available

  • Helsinki Univeristy Central Hospital

    Helsinki,
    Finland

    Site Not Available

  • Department of Pediatrics, Oulu University Hospital

    Oulu, 90014
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere,
    Finland

    Site Not Available

  • Turku University Hospital

    Turku,
    Finland

    Site Not Available

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