Paracetamol Versus Ibuprofen for PDA Closure

Phase 4

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: ibuprofen; Drug: paracetamol

• Registration Number: NCT03265782
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-03-10
• Study Start: 2015-06
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-28
• Last Update Submitted: 2017-08-28
• Study First Posted: 2017-08-29
• Last Update Posted: 2017-08-29
• Primary Completion: 2017-09
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen group	ibuprofen	treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done
paracetamol group	paracetamol	treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done

Primary Outcome Measures

Name	Time	Method
closure of PDA	6 days	Echo confirmed closure