NCT01536158

Brief Summary

The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

9 months

First QC Date

February 15, 2012

Last Update Submit

December 24, 2012

Conditions

Patent Ductus Arteriosus

Keywords

Patent Ductus ArteriosusParacetamolIbuprofenPreterm infant

Outcome Measures

Primary Outcomes (1)

  • Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen

    To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment

    Until discharge

Secondary Outcomes (1)

  • Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants

    corrected 36 weeks or until discharge

Study Arms (2)

Oral paracetamol

ACTIVE COMPARATOR

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.

Drug: Oral paracetamol

Oral ibuprofen

ACTIVE COMPARATOR

Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Drug: Oral ibuprofen

Interventions

Oral paracetamolDRUG

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.

Also known as: Calpol
Oral paracetamol
Oral ibuprofenDRUG

Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Also known as: Pedifen
Oral ibuprofen

Eligibility Criteria

Age2 Days - 10 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight below 1250 gram
  • Diagnosed patent ductus arteriosus by Echocardiographic examination

You may not qualify if:

  • Accompanied other congenital cardiac anomalies
  • Urine output of less than 1 ml/kg/h during the preceding 8 h,
  • Serum creatinine level \>1.6 mg/dl,
  • Platelet count \<60,000/mm3,
  • Liver failure,
  • Hyperbilirubinemia requiring exchange transfusion
  • Severe intracranial bleeding (Grade III - IV)
  • Intestinal abnormality and necrotising enterocolitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (3)

  • Jasani B, Mitra S, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev. 2022 Dec 15;12(12):CD010061. doi: 10.1002/14651858.CD010061.pub5.

    PMID: 36519620DERIVED

  • Oncel MY, Eras Z, Uras N, Canpolat FE, Erdeve O, Oguz SS. Neurodevelopmental Outcomes of Preterm Infants Treated with Oral Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus. Am J Perinatol. 2017 Oct;34(12):1185-1189. doi: 10.1055/s-0037-1601564. Epub 2017 Apr 10.

    PMID: 28395364DERIVED

  • Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.

    PMID: 24359938DERIVED

Related Links

MeSH Terms

Conditions

Ductus Arteriosus, PatentPremature Birth

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Mehmet Yekta Oncel, MD

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zekai Tahir Burak Maternity and Teaching Hospital

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 20, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

December 27, 2012

Record last verified: 2012-12

Locations

TU(1)