A study to determine the efficacy of restricted fluid administration in improving health of babies who have brain injury due to less oxygen during birth.

Fluid restriction for term infants with hypoxic- ischaemic encephalopathy following perinatal asphyxia-a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008156

Enrollment

210

Registered

2017-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: 3- Administration Health Condition 2: null- Neonates with perinatal asphyxia Health Condition 3: P039- Newborn affected by complication of labor and delivery, unspecified

Interventions

Intervention1: restricted fluid: newborn will be given less amount of total intravenous fluids during the first 6 days in ml/Kg/day 45 60 75 90 105 120 The total duration of intervention is 6 days.

Eligibility

Inclusion criteria

Inclusion criteria: neonate with perinatal asphyxia

Exclusion criteria

Exclusion criteria: neonate with congenital malformation

Design outcomes

Primary

Measure	Time frame
PRIMARY OUTCOME: Neonatal mortality or severe neurodevelopmental disability at discharge. Timepoint: at discharge.	—

Secondary

Measure	Time frame
1)electrolyte disturbances 2)Urine output1ml/kg/h during the first three days of life. 3)Abnormal renal function after the first 24 hours of life as a reflection of the asphyxia insult . 4)Seizures requiring anticonvulsants: detection of seizures based on either clinical grounds,detection by electroencephalogram, or by treatment of seizures with antiepilectic treatment. 5) CT or MRI changes consistent with asphyxia Timepoint: electrolytes on day 1 and day 2 urine output on day 1,2 and 3 Renal function on day 2 seizures during admission(day 1-7) MRI at discharge	—

Measure

Time frame

1)electrolyte disturbances 2)Urine output1ml/kg/h during the first three days of life. 3)Abnormal renal function after the first 24 hours of life as a reflection of the asphyxia insult . 4)Seizures requiring anticonvulsants: detection of seizures based on either clinical grounds,detection by electroencephalogram, or by treatment of seizures with antiepilectic treatment. 5) CT or MRI changes consistent with asphyxia Timepoint: electrolytes on day 1 and day 2 urine output on day 1,2 and 3 Renal function on day 2 seizures during admission(day 1-7) MRI at discharge

—

Countries

India

Contacts

Public ContactDr Anitha Ananthan

Seth G.S.Medical College and KEM hospital Mumbai

ani.gem81@gmail.com9769660870

Outcome results

None listed

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