Oral ibuprofen versus paracetamol on ductus arteriosus

Comparison of oral paracetamol versus ibuprofen for PDA closure in preterms â?? a randomized controlled single blinded study - IPOD

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/09/007261

Enrollment

150

Registered

2016-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Preterm with PDA

Interventions

Intervention1: Paracetamol: 15mg/Kg/dose every 6th hourly for 2 days by oral/ orogastric route Control Intervention1: Ibuprofen: 10mg/Kg stat followed by 5 mg/kg once daily for 2 days by oral/orogast

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates 1. Congestive cardiac failure 2. Mechanical ventilation 3. LA / Aortic root ratio > 1.5

Exclusion criteria

Exclusion criteria: Presence of other cardiac anomalies or duct dependant lesions. 2. Major congenital malformations. 3. Oliguria ( urine output 4. S. creatinine >1.6mg/dl 5. Intra ventricular hemorrhage within the last 24 hours 6. Necrotizing enterocolitis 7. Abnormal liver function test. 8. Platelet count

Design outcomes

Primary

Measure	Time frame
Echocardiographic closure of hs PDATimepoint: Echocardiographic closure of hs PDA 24 hours after completion of course.	—

Secondary

Measure	Time frame
Cardio respiratory morbidity & mortalityTimepoint: 28 days;Growth & neurodevelopment1Timepoint: 1 year	—

Countries

India

Contacts

Public ContactBharathi B

JIPMER

drvishnubhat@yahoo.com9842351282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026