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

Ductus Arteriosus, Patent Clinical Trial

Official title:

Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002741
• Other study ID #: IBUACA CTIL
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of patent ductus arteriosus closure	By echocardiography	3-10 days after first dose of Ibuprofen + study drug
Secondary	Adverse effects	Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records	until discharge home (usually within 2-3 months since recruitment)
Secondary	The need for surgical ligation for PDA	need for surgical ligation for PDA	3-21 days after first dose of Ibuprofen + study drug