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Choice of intravenous fluids for volume expansion in neonates with shock

Volume expansion with Ringers Lactate versus Normal Saline in neonates with shock requiring fluid therapy an open labelled randomized controlled trial - VeRN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102973
Enrollment
154
Registered
2026-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: I959- Hypotension, unspecified

Interventions

Intervention1: Ringers Lactate solution: In neonates with shock requiring volume expansion, Ringers lactate will be given at 10ml/kg over 30 minutes and will be assessed thereafter for improvement of

Sponsors

IMS and SUM Hospital SOA University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born between 28 to 40 weeks of gestational age with 1st episode of shock

Exclusion criteria

Exclusion criteria: A.Critically sick and considered non-viable by clinicians B.Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus) C.Chromosomal abnormalities

Design outcomes

Primary

MeasureTime frame
Need for vasopressor after Volume expansion with Ringer lactate as compared to Normal Saline.Timepoint: Upto 48 hours—

Secondary

MeasureTime frame
Need for additional bolus of crystalloids.Timepoint: Upto 48 hours;Need for more than one vasopressor supportTimepoint: Upto 48 hours;Duration of inotropesTimepoint: Discharge;All-cause mortalityTimepoint: 36 weeks PMA;Severe brain injury IVH grade 2 and above, PVLTimepoint: Discharge;Change in the lactate levelsTimepoint: Upto 48 hours;Changes in bicarbonate levelsTimepoint: Upto 48 hours;Changes in chloride levels.Timepoint: Upto 48 hours;Cardiac output assessmentTimepoint: Baseline, 48 hours—

Countries

India

Contacts

Public ContactDr. Debasish Nanda

IMS and SUM HOSPITAL (SOA UNIVERSITY)

debasishnanda@soa.ac.in9861422685

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026