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

Primary Purpose

Ductus Arteriosus, Patent

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Paracetamol
Placebo
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductus Arteriosus, Patent focused on measuring patent ductus arteriosus, PDA, Preterm, Infant, Electrocardiography, Paracetamol, Acamol, ibuprofen, Placebo

Eligibility Criteria

2 Days - 2 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ibuprofen + Paracetamol

Ibuprofen + Placebo

Arm Description

Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Intravenous Paracetamol : Loading dose 20mg/kg --> 10 mg/kg q6h for total of 12 doses

Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h.

Outcomes

Primary Outcome Measures

The incidence of patent ductus arteriosus closure
By echocardiography

Secondary Outcome Measures

Adverse effects
Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records
The need for surgical ligation for PDA
need for surgical ligation for PDA

Full Information

First Posted
November 24, 2013
Last Updated
February 16, 2020
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02002741
Brief Title
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants
Official Title
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosus, Patent
Keywords
patent ductus arteriosus, PDA, Preterm, Infant, Electrocardiography, Paracetamol, Acamol, ibuprofen, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen + Paracetamol
Arm Type
Active Comparator
Arm Description
Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Intravenous Paracetamol : Loading dose 20mg/kg --> 10 mg/kg q6h for total of 12 doses
Arm Title
Ibuprofen + Placebo
Arm Type
Placebo Comparator
Arm Description
Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Acetaminophen, Acamol
Intervention Description
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl 0.9%
Intervention Description
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Primary Outcome Measure Information:
Title
The incidence of patent ductus arteriosus closure
Description
By echocardiography
Time Frame
3-10 days after first dose of Ibuprofen + study drug
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records
Time Frame
until discharge home (usually within 2-3 months since recruitment)
Title
The need for surgical ligation for PDA
Description
need for surgical ligation for PDA
Time Frame
3-21 days after first dose of Ibuprofen + study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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