Two different fluid volumes in extremely preterm or extremely low birth weight neonates: a randomized trial
Phase 3
- Conditions
- Health Condition 1: P070- Extremely low birth weight newborn
- Registration Number
- CTRI/2023/04/051387
- Lead Sponsor
- ICU AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Preterm babies less than or equal to 27+6 weeks, OR
2. Birth weight < 1000 g
3. Babies, meeting criteria 1 or 2, born outside AIIMS, if referred within 6 hours of birth
Exclusion Criteria
1. No major cardiac, renal or surgical abnormalities
2. No chromosomal abnormalities
3. Parents opting for compassionate care in peri-viable gestation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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