Comparison of safety and efficicay between oral ibuprofen and intravenous paracetamol in the closure of Patent Ductus Arteriosus in preterm neonates.

â??â??COMPARISON OF EFFICACY AND SAFETY OF ORAL IBUPROFEN VERSUS INTRAVENOUS PARACETAMOL IN THE CLOSURE OF PATENT DUCTUS ARTERIOSUS IN PRETERM NEONATES, A ONE YEAR RANDOMISED CONTROL TRIAL.â??â??

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042641

Enrollment

Registered

2022-05-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-30

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ibuprofen: Oral route 10mg/kg/day-1st day-once a day 5mg/kg/day-next 2 days-once a day total duration-3 days Control Intervention1: Paracetamol : Intravenous 15mg/kg/dose 4 times a day

Eligibility

Inclusion criteria

Inclusion criteria: All preterm neonates with 2Decho diagnosed PDA

Exclusion criteria

Exclusion criteria: SEPTIC SHOCK THROMBOCYTOPENIA RENAL FAILURE ACTIVE BLEEDING ACTIVE NEC

Design outcomes

Primary

Measure	Time frame
Closure of patent ductus arteriosus in preterm neonates after 3 days of specific treatment.Timepoint: 3 days	—

Secondary

Measure	Time frame
To compare the safety in terms of Hemoglobin Platelets Serum electrolytes Total counts Renal functions tests Liver function testsTimepoint: 1 YEAR	—

Countries

India

Contacts

Public ContactDR Smruthi Rugi

JNMC BELGAUM

veereshmanvi@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026