Paracetamol Versus Ibuprofen for PDA Closure

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03265782

Enrollment

Registered

2017-08-29

Start date

2015-06-30

Completion date

2018-01-31

Last updated

2017-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Keywords

efficacy, safety, paracetamol, ibuprofen, PDA, preterms

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.

Interventions

DRUGibuprofen

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

DRUGparacetamol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 35 Weeks

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
closure of PDA	6 days	Echo confirmed closure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026