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

NCT02002741 | Completed Phase 2

• 1 other identifier: IBUACA CTIL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductus Arteriosus, Patent

Keywords

patent ductus arteriosus; PDA; Preterm; Infant; Electrocardiography; Paracetamol; Acamol; ibuprofen; Placebo

Outcome Measures

Primary Outcomes (1)

• The incidence of patent ductus arteriosus closure

  By echocardiography

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

Secondary Outcomes (2)

• Adverse effects

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

• The need for surgical ligation for PDA

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

Study Arms (2)

Ibuprofen + Paracetamol

ACTIVE COMPARATOR

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

Drug: Paracetamol

Ibuprofen + Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Paracetamol DRUG

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

Also known as: Acetaminophen, Acamol

Ibuprofen + Paracetamol

Placebo DRUG

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

Also known as: NaCl 0.9%

Ibuprofen + Placebo

Eligibility Criteria

• Age: 2 Days - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 6, 2013
• Study Start: August 1, 2014
• Primary Completion: May 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)