Effect of Early Fortification Versus Delayed Fortification of Human Milk on Anthropometric Parameters in Very Low birth Weight Infants: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier
Study Overview
Brief Summary
The current study aims to examine the effects of early fortification (initiating at 80 ml/kg/day) versus late fortification (initiating at 120 ml/kg/day) on the time taken to regain birth weight in preterm infants and weight gain velocity pattern following that along with head circumference and length increments. Understanding this could enhance nutritional protocols in the NICU, supporting the growth and development of this vulnerable population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 0.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All inborn newborn admitted in NICU with Birth weight less than 1500 grams.
Exclusion Criteria
- •Major congenital anomalies.
Outcomes
Primary Outcomes
Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier
Time Frame: Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier
Secondary Outcomes
- increase in head circumference (cm/week) and length (cm/week) till discharge.(till discharge)
- Correlation between total protein intake and time to regain birth weight in days , weight(gain velocity , head circumference cm/ week, length cm /week.)
- Incidence of NEC stage 2 or more as per modified Bell’s stage.(till discharge)
- Feed intolerance incidence(till discharge)
- All cause mortality(In hospital)(till discharge)
- Incidence of extrauterine growth restriction at discharge (number of infants with weight <(10th percentile for the index population))
- Incidence of ROP requiring treatment(Till discharge)
- BPD incidence(till discharge)
Investigators
Dr Sushil Kumar Choudhary
All India Institute of Medical sciences, Jodhpur