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A study to determine whether closure of Patent ductus arteriosus with indomethacin on the basis of size in the first 24 hrs of life in preterm babies between 28-32 weeks having respiratory difficulty is required or not.

A Randomized Controlled Trial comparing Indomethacin vs. No treatment for PDA on the basis of Size in the first 24 hrs of life in Preterm babies between 28 to 32 weeks gestation requiring Assisted Ventilation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000041
Enrollment
Unknown
Registered
2009-02-03
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

None listed

Interventions

Intervention1: Indomethacin: 0.2mg/kg intravenously followed by 0.1 mg/kg 2 doses every 24 hrs Control Intervention1: No Treatment: NIL

Sponsors

Anil Batra
Lead Sponsor
Satish Saluja
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Preterm 28 - 32 weeks admitted to NICU within 12 hrs of birth Ventilatory support for respiratory distress PDA more than or equal to 2 mm in size in the first 24 hrs of life

Exclusion criteria

Exclusion criteria: Babies with major congenital malformations Any contraindication of giving indomethacin Babies with severe asphyxia as defined by Apgar score, <3 at 5 min of life with cord/with in 1 hour of life pH< 7.0 or base excess >16 Shock requiring pressor support at time of randomization Refusal to obtain consent Gestation below 28 weeks Presence of other cardiac malformations including ASD, VSD, any cause of left ventricular dysfunction and mitral valve abnormalities

Design outcomes

Primary

MeasureTime frame
Closure of PDA at 7 days of lifeTimepoint: 7 days—

Secondary

MeasureTime frame
Duration of assisted ventilation Hemodynamically significant PDA at 3 days of age Pulmonary hemorrhage Intraventricular haemorrhage Duration of oxygen dependence Duration of hospital stay Sepsis Side effects related to indomethacin Timepoint: 3 days Nursery stay—

Countries

India

Contacts

Public ContactSatish saluja

Sir Ganga Ram Hospital, New Delhi

ssaluja@vsnl.com911142251738

Outcome results

None listed

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