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To compare the effectiveness of high doses versus low dose of caffeine given before removing breathing tubes in newborns on ventilators to see which helps them breathe on their better own.

Efficacy of Pre-extubation High Dose vs Low Dose Caffeine Administration For Success of Weaning in Mechanically Ventilated Newborns - A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079530
Enrollment
128
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Efficacy of Pre - Extubation High Dose v/s low dose Caffeine Administration for Success of Weaning in Mechanically Ventilated Newborns - A Randomized Controlled Trial: The intervention

Sponsors

Yusuf Khairullah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All newborns admitted in the Neonatal intensive care unit. All newborns with invasive mechanical ventilation of more than 48 hours

Exclusion criteria

Exclusion criteria: All healthy newborns in the Postnatal care unit are excluded. All newborns with invasive mechanical ventilation of less than 48 hours

Design outcomes

Primary

MeasureTime frame
To compare pre-extubation high and low dose caffeine administration in mechanically ventilated newborns for success of weaning in terms of : 1. Re-intubation rates 2. Duration of non-invasive ventilation needed Timepoint: Newborns will be assessed daily i.e every 24 hourly till they are weaned completely off non invasive ventilation—

Secondary

MeasureTime frame
To compare the efficacy of high-dose & low-dose caffeine administration in reducing the duration of supplemental oxygen requirement post-extubation in mechanically ventilated newborns. Timepoint: Newborns will be assessed every 24 hours till they are completely weaned off oxygen.—

Countries

India

Contacts

Public ContactYusuf Khairullah

N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital

dranjaliedbor@gmail.com9822470808

Outcome results

None listed

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