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Restricted vs liberal intravenous fluid administration in preterm newborns less than 1 Kilogram

Restricted versus conventional fluid administration in Extremely Low Birth Weight neonates: A randomised control non-inferiority trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066302
Enrollment
100
Registered
2024-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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: restricted fluid: Administration of restricted fluid at the rate of 60ml/Kg/day on day 1, and incrementing at the rate of 20ml/Kg/day till day 5, followed by 150ml/Kg/day from day 6 onw

Sponsors

Dr Anitha Haribalakrishna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All extremely low birth weight neonates less than 1000 grams

Exclusion criteria

Exclusion criteria: Neonates with major congenital anomaly

Design outcomes

Primary

MeasureTime frame
all cause mortality Timepoint: 4 weeks

Secondary

MeasureTime frame
Neonatal morbiditiesTimepoint: During NICU stay or at discharge

Countries

India

Contacts

Public ContactDr Anitha Haribalakrishna

Seth GSMC and KEM Hospital Mumbai

ani.gem81@gmail.com9769660870

Outcome results

None listed

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