Paracetamol Versus Ibuprofen for PDA Closure

Patent Ductus Arteriosus Clinical Trial

Official title:

Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03265782
• Other study ID #: 43214321
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 10, 2015
• Last updated: August 28, 2017
• Start date: June 2015
• Est. completion date: January 2018

Study information

• Verified date: August 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants

Description:

A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct.

Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 35 Weeks

Eligibility

Inclusion Criteria:

1. Gestational age = 35 weeks

2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA

3. Urine output more than 1 ml/kg/hr

4. Creatinine concentration level less than 1.8 mg/dl

Exclusion Criteria:

Neonates who have one or more of the following criteria were excluded from the study:

1. Congenital heart diseases of any type including

• Pulmonary stenosis

• Anomalus in pulmonary venous drainage

• Ventricular septal defect

2. Major congenital anomalies as hydrops fetalis

3. Low platelets count (less than 60, 000/mm3)

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• ibuprofen
drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days
• paracetamol
drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	closure of PDA	Echo confirmed closure	6 days