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To determine the effectiveness and safety of high dose ibuprofen compared with standard dose ibuprofen for closing a patent ductus arteriosus (an open vascular channel between the lungs and the heart) in preterm, lowâ??birthâ??weight, or preterm and lowâ??birthâ??weight infants.

High dose ibuprofen versus standard dose ibuprofen in closure of patent ductus arteriosus in preterm neonates less than 36weeks - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026183
Enrollment
102
Registered
2020-06-26
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

Interventions

Intervention1: nil: nil Control Intervention1: To compare the efficacy of high dose ibuprofen versus standard dose ibuprofen in closure of patent ductus arteriosus in preterm neonates admitted in NICU

Sponsors

Dr Kishor Gandhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm babies < 36 weeks admitted to NICU with hemodynamically significant PDA

Exclusion criteria

Exclusion criteria: A.Neonates with critical congenital cardiac disease B.Neonates with contraindication for the Ibuprofen 1.Thrombocytopenia â?? PLT 2.IVH grade 2 or more 3.NNEC grade 2 or more 4.Serum creatinine >1.6 MG/DL 5.Serum Urea >60 MG/DL 6.Serum bilirubin level within 2mg/dl of the exchange range as per NICE guidelines. 7.Coagulopathy â?? deranged PT or aPTT value (adjusted for gestational age and post natal age).

Design outcomes

Primary

MeasureTime frame
To compare the closure rates of patent ductus arteriosus in high dose ibuprofen and standard dose ibuprofenTimepoint: on 4th day since starting the treatment.—

Secondary

MeasureTime frame
1.Time take for the closure of the PDA 2.Number of course needed 3.Incidence of re-opening of pda 4.To compare the adverse events associated with ibuprofen usage â?? thrombocytopenia , acute kidney injury, oliguria, necrotizing enterocollitis and intra-ventricular hemorrhage 5.To compare adverse associated with HSPDA - increased ventilator requirement, pulmonary hemorrhage, duration of mechanical ventilation, mean fio2 requirement and duration of requirement any respiratory support. Timepoint: Till 4th day since starting the treatment.—

Countries

India

Contacts

Public ContactDr Kishor Gandhi

Dr Mehta Multispeciality Hospitals India Pvt. Ltd.

drlakshmi2008@gmail.com9840211742

Outcome results

None listed

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