Two different fluid volumes in extremely preterm or extremely low birth weight neonates: a randomized trial

Comparison of two different initial fluid volumes in extremely preterm or extremely low birth weight neonates: a randomized trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051387

Enrollment

100

Registered

2023-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Health Condition 1: P070- Extremely low birth weight newborn

Interventions

Intervention1: TFR 100 ml/kg/day: Total fluid rate on day of life 1 will be 100 ml/kg/day including drugs, fluids and feeds Control Intervention1: TFR 80 ml/kg/day: Total fluid rate of day of life 1 w

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm babies less than or equal to 27+6 weeks, OR 2. Birth weight 3. Babies, meeting criteria 1 or 2, born outside AIIMS, if referred within 6 hours of birth

Exclusion criteria

Exclusion criteria: 1. No major cardiac, renal or surgical abnormalities 2. No chromosomal abnormalities 3. Parents opting for compassionate care in peri-viable gestation

Design outcomes

Primary

Measure	Time frame
Day of regaining birth weight between extremely premature or extremely low birth weight neonates receiving total fluid volume of 100 ml/kg/day or 80 ml/kg/day on first day of lifeTimepoint: Day of regaining birth weight between extremely premature or extremely low birth weight neonates receiving total fluid volume of 100 ml/kg/day or 80 ml/kg/day on first day of life	—

Secondary

Measure	Time frame
Incidence of hypernatremia, hyponatremia, hyperglycemia, hypoglycemia, necrotizing enterocolitis, acute kidney injuryTimepoint: Till hospital stay;Mortality till 28 daysTimepoint: 28 days of life;To compare the incidence of BPDTimepoint: At 36 weeks PMA/ hospital discharge, whichever is earlier;To compare the incidence of EUGRTimepoint: At term equivalent gestation;To compare the incidence of PDA, IVHTimepoint: Till hospital discharge;To compare the incidence of ROPTimepoint: Till complete retinal vascularization;To compare the mean weight gain, length gain and head circumference gainTimepoint: From the day of regaining birth weight till hospital discharge;To compare the urine output and urine specific gravityTimepoint: Till regaining of birth weight;To compare the weight loss nadirTimepoint: Till regaining of birth weight	—

Measure

Time frame

Incidence of hypernatremia, hyponatremia, hyperglycemia, hypoglycemia, necrotizing enterocolitis, acute kidney injuryTimepoint: Till hospital stay;Mortality till 28 daysTimepoint: 28 days of life;To compare the incidence of BPDTimepoint: At 36 weeks PMA/ hospital discharge, whichever is earlier;To compare the incidence of EUGRTimepoint: At term equivalent gestation;To compare the incidence of PDA, IVHTimepoint: Till hospital discharge;To compare the incidence of ROPTimepoint: Till complete retinal vascularization;To compare the mean weight gain, length gain and head circumference gainTimepoint: From the day of regaining birth weight till hospital discharge;To compare the urine output and urine specific gravityTimepoint: Till regaining of birth weight;To compare the weight loss nadirTimepoint: Till regaining of birth weight

—

Countries

India

Contacts

Public ContactTanushree Sahoo

AIIMS, Bhubaneswar

neonat_tanushree@aiimsbhubaneswar.edu.in09646832949

Outcome results

None listed

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