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Effect of increasing caffeine intake compared to usual maintenance dose in preterm neonates: A Randomised Controlled Trial

Effect of escalating versus standard maintenance dose of caffeine in preterm neonates: A Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057903
Enrollment
110
Registered
2023-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: P289- Respiratory condition of newborn,unspecified

Interventions

Intervention1: caffeine: dose of caffeine 5mg/kg/day to 8mg/kg/day,per oral route,till 34weeks of gestation or baby will be under room air for 7 days whichever comes first Control Intervention1: stan

Sponsors

Government Medical College and Hospital, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn neonates born at completed gestational age =26 0/7 to 31 6/7 weeks, requiring invasive or non-invasive respiratory support in first 7 days of life

Exclusion criteria

Exclusion criteria: 1-Neonates on invasive ventilation at time of primary outcome assessment 2-IVH (Grade = III as per Papile Grading classification) 3-Major congenital malformations 4-Moribund neonates ? Neonates with pulmonary hypertension

Design outcomes

Primary

MeasureTime frame
cumulative duration of Intermittent hypoxemiaTimepoint: at thirty three weeks & six days of gestation

Secondary

MeasureTime frame
1-Cumulative Duration of IH measured at end of week 2 ,3 & 4 of caffeine initiation (i.e SpO2 80% measured over a 12-hour period) 2-Frequency of IH episodes at end of week 2,3 & 4 of caffeine initiation (i.e number of events of SpO2 80% measured over a 12-hour period) Timepoint: at end of week 2 ,3 & 4 of caffeine initiation

Countries

India

Contacts

Public ContactDr Hemant Gupta

Government medical college and hospital, chandigarh

supreetkhurana85@gmail.com7087612359

Outcome results

None listed

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