Comparison of outcomes of single drug therapy versus dual drug therapy in the treatment of hemodynamically significant PDA

Comparative efficacy of combined pharmacotherapy (Ibuprofen + Paracetamol) versus monotherapy (Ibuprofen) in the treatment of hemodynamically significant PDA - A Double Blind Randomised Controlled Trial at a level III NICU in LMIC - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066914

Enrollment

100

Registered

2024-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Interventions

Intervention1: Ibuprofen plus Paracetamol combination suspension: Ibuprofen + Paracetamol: 10mg/kg body weight of Ibuprofen orally on day 1 followed by 5mg/kg on day 2 and day 3 Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm neonates less than 32 week admitted in the NICU with hemodynamically significant PDA between 12 and 72 hours of life. 2. Written Informed parental or guardian consent obtained

Exclusion criteria

Exclusion criteria: 1. Major lethal congenital malformations 2.Echocardiographic evidence of pulmonary hypertension. 3. IVH grade III or more 4. Platelet count less than 50,000/mm3

Design outcomes

Primary

Measure	Time frame
Primary Outcome To determine Combined outcome of death and/ or BPD evaluated at thirty six weeks of Postmenstrual age. Timepoint: Thirty six weeks postmenstrual age.	—

Secondary

Measure	Time frame
Secondary Outcome 1.IVH Grade III or more 2.NEC Stage II or more 3.Ductal closure on day three and seven 4.Duration of respiratory support.Timepoint: At discharge	—

Countries

India

Contacts

Public ContactDr LS Deshmukh

Government Medical College and Hospital, Aurangabad

deshmukhls@yahoo.com9822478275

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026