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A clinical trial to study optimal fluid management in newborns with birth asphyxia

Effect of full vs restricted fluids on the outcome of newborns with perinatal asphyxia: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010175
Enrollment
50
Registered
2017-10-24
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

Health Condition 1: null- Newborns with moderate to severe birth asphyxia

Interventions

Intervention1: Full fluid: Intravenous fluid at the rate of 90 ml/kg/day with a daily increment of 15 ml/kg/day for first 72 hours of life Control Intervention1: Restricted fuid: 2/3 of full fluid ie.

Sponsors

Vasudha Tomar
Lead Sponsor
Dr Prof Ruchi Rai MD
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Full term neonate ( >= 37 weeks gestational age) Less than 6 hours of age Moderate to severe birth asphyxia (Apgar score at 5 min <= 6)

Exclusion criteria

Exclusion criteria: 1.Newborns presenting with shock/ bleeding 2.Newborns with gross congenital malformations

Design outcomes

Primary

MeasureTime frame
1. Mortality during hospital stay in term neonates with moderate to severe birth asphyxia in both groups 2. Neurological status of neonates at dischargeTimepoint: 0-7 days—

Secondary

MeasureTime frame
1. Need of second anticonvulsant in both groups 2. Electrolyte imbalance observed at 24 hrs of life 3. Duration of hospital stayTimepoint: 0-7days—

Countries

India

Contacts

Public ContactVasudha Tomar

SSPHPGTI

ruchiraialld@gmail.com8576080311

Outcome results

None listed

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