paracetamol versus ibuprofen in the management of patent ductus arteriosus (congenital heart disease) in preterm infants

To study the efficacy and safety of oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosusin preterm infants:A randomised controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011942

Enrollment

Registered

2018-02-19

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: Q250- Patent ductus arteriosus Health Condition 2: null- preterm infants with patent ductus arteriosus Health Condition 3: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: paracetamole: paracetamole inhibits peroxidase.paracetamole exposure and systemic PG reduction related PDA CLOSURE Control Intervention1: IBUPROFEN: ibuprofen mechanism of action is an

Eligibility

Inclusion criteria

Inclusion criteria: 1 age less than 32 weeks 2 weight less than 1250gm 3 2Decho suggestive of patent ductus arteriosus

Exclusion criteria

Exclusion criteria: 1presence of congenital anomaly 2right to left ductal shunting 3liver failure 4persistent pulmonary hypertension

Design outcomes

Primary

Measure	Time frame
rates of ductal closure of both drugs after treatmentTimepoint: on third day of life will be assesed primary outcome	—

Secondary

Measure	Time frame
the safety of both drugs including early and late adverese eventTimepoint: 7days to 30 days	—

Countries

India

Contacts

Public Contacthinal asinol

govt.medical college bhavanagar

jayukids@yahoo.com9824090049

Outcome results

None listed

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