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A scientific study to compare the role of reduced intravenous fluid administration versus normal intravenous fluid administration on the death and developmental outcome among newborns with perinatal asphyxia treated with therapeutic hypothermia.

Effect of Fluid restriction on the Mortality and Morbidity of Term newborns with Perinatal asphyxia treated with Therapeutic hypothermia: Randomised control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/11/007431
Enrollment
80
Registered
2016-11-03
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- Term newborns with birth asphyxia

Interventions

Intervention1: FLUID RESTRICTED GROUP: Fluid regimen to be followed in thIS will be 40ml/kg, 55ml/kg, 65ml/kg and 80ml/kg Control Intervention1: NON FLUID RESTRICTED GROUP: . Fluid regimen to be follo

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gestational, age >= 36 weeks ABG(umbilical cord or 1st postnatal hour pH = 12 meq OR i. APGAR ii. Assisted ventilation for at least 10 min after birth iii. History of acute perinatal event- intrapartum fetal distress, cord prolapse placental abruption . Above criteria in presence of moderate or severe encephalopathy by clinical examination.

Exclusion criteria

Exclusion criteria: i. Infants >6 hours of age at the time of randomization. ii. Major congenital abnormalities. iii. Maternal renal failure

Design outcomes

Primary

MeasureTime frame
1. To compare the composite outcome of death or major neurodevelopmental disability at 6 months of age between fluid restricted and non fluid restricted groups. Timepoint: Six months of life.—

Secondary

MeasureTime frame
1. To study the changes in serum electrolytes, serum osmolarity, renal and neurological clinical parameters between term asphyxiated newborns treated with fluid restriction and without fluid restriction. . 2. To correlate the parameters like change in serum sodium, change in serum osmolarity, incidence of hypoglycemia, incidence of acute kidney injury, incidence of shock and neonatal seizures to outcome. Timepoint: At six months of life.—

Countries

India

Contacts

Public ContactNishad Plakkal

JIPMER

plakkal@yahoo.com

Outcome results

None listed

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