Paracetamol versus Ibuprofen For Closure of Patent Ductus Arteriosus

Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates less than or equal to 34 Weeks or less than or equal to 1800 gms: A Randomized Control Trial - BAP trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/009989

Enrollment

120

Registered

2017-10-03

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 Neonates less than or equal to 34weeks or less than or equal to 1800gms

Interventions

Intervention1: ORAL PARACETAMOL: Paracetamol will be given at 15mg/kg 8hourly for 3 days Control Intervention1: ORAL IBUPROFEN: 3 doses ibuprofen will be given at 24 h interval at a dose of 10, 5, 5mg

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates born at less than or equal to 34 weeks or birth weight less than or equal to 1800gms with hemodynemically significant Patent Ductus Arteriosus

Exclusion criteria

Exclusion criteria: If any one of the following present (1)Congenital heart disease which required PDA to maintain blood flow; (2)Septic shock; (3) Recent (within the previous 24 h) IVH,grade 3â??4; (4) Urine output less than 1 ml/kg/h in preceding 8h; (5) Serum creatinine more than 1.0mg/dl; (6) Platelet count less than 50000/mm3; (7) Hyper-bilirubinemia requiring exchange transfusion; (8) necrotizing enterocolitis; (9)Severe liver failure, defined as elevated liver enzymes SGOT/SGPT more than 2times, the upper limit of normal range; (10)Previous treatment with paracetamol, ibuprofen or any COX inhibitor, for any purpose; (11)Refusal of consent

Design outcomes

Primary

Measure	Time frame
Primary closure rate of PDA after the first course of the drugTimepoint: Till recruitment of last patient as calculated in sample size.	—

Secondary

Measure	Time frame
All cause mortality Timepoint: Till recruitment of last patient as calculated in sample size.;Duration of hospitalization.Timepoint: Till recruitment of last patient as calculated in sample size.;Duration of mechanical ventilation or nasal continuous positive airway pressure (nCPAP) use or duration of need for supplementary oxygenTimepoint: Till recruitment of last patient as calculated in sample size.;early ( 7days after first dose) / late adverse events- Intraventricular Haemorrhage, Peri-ventricular Leukomalacia, Necrotizing Enterocolitis, intestinal perforation, gastrointestinal bleed, Oliguria (urine output 1 ml/kg/hr), acute renal failure, Acute liver injury, hyperbilirubinemia, Sepsis, Broncho-Pulmonary Dysplasia, Retinopathy of Prematurity, Pulmonary hemorrhage, Pulmonary hypertension.Timepoint: Till recruitment of last patient as calculated in sample size.;Mean days needed for closure of PDATimepoint: Till recruitment of last patient as calculated in sample size.;Re-opening rate during hospitalizationTimepoint: Till recruitment of last patient as calculated in sample size.;Requirement of other drugs or surgery for closure of the PDA following treatment failureTimepoint: Till recruitment of last patient as calculated in sample size.;Secondary closure rate of PDA after the second course of the drugTimepoint: Till recruitment of last patient as calculated in sample size.	—

Measure

Time frame

All cause mortality Timepoint: Till recruitment of last patient as calculated in sample size.;Duration of hospitalization.Timepoint: Till recruitment of last patient as calculated in sample size.;Duration of mechanical ventilation or nasal continuous positive airway pressure (nCPAP) use or duration of need for supplementary oxygenTimepoint: Till recruitment of last patient as calculated in sample size.;early ( 7days after first dose) / late adverse events- Intraventricular Haemorrhage, Peri-ventricular Leukomalacia, Necrotizing Enterocolitis, intestinal perforation, gastrointestinal bleed, Oliguria (urine output 1 ml/kg/hr), acute renal failure, Acute liver injury, hyperbilirubinemia, Sepsis, Broncho-Pulmonary Dysplasia, Retinopathy of Prematurity, Pulmonary hemorrhage, Pulmonary hypertension.Timepoint: Till recruitment of last patient as calculated in sample size.;Mean days needed for closure of PDATimepoint: Till recruitment of last patient as calculated in sample size.;Re-opening rate during hospitalizationTimepoint: Till recruitment of last patient as calculated in sample size.;Requirement of other drugs or surgery for closure of the PDA following treatment failureTimepoint: Till recruitment of last patient as calculated in sample size.;Secondary closure rate of PDA after the second course of the drugTimepoint: Till recruitment of last patient as calculated in sample size.

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Countries

India

Contacts

Public ContactVivek Kumar Athwani

vathwani@gmail.com9982664234

Outcome results

None listed

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