Full volume feeding in preterm babies with birth weight of 750-1250 grams
Phase 3
- Conditions
- Health Condition 1: P929- Feeding problem of newborn, unspecifiedHealth Condition 2: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2023/09/057882
- Lead Sponsor
- ady Hardinge Medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Preterm neonate with birth weight between 750- 1250 grams
2) Infants < 2 h (120 min) old (since recorded time of birth).
Exclusion Criteria
1)Antenatally diagnosed Gastrointestinal malformation
2)Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler.
3)Presence of major congenital anomalies at birth
4)Need of vasopressor support at the time of randomization
5)Requiring Positive Pressure Ventilation > 60 sec with APGAR score < 4 at 1 minute
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the time of attainment of full enteral feeds (in completed days) in preterm neonates with birth weight between 750-1250 grams started on early total enteral feeding (ETEF) as compared to those started on conventional enteral feeding (CEF)Timepoint: Daily till discharge or death
- Secondary Outcome Measures
Name Time Method 1.Magnitude of feed intolerance, Sepsis, Necrotising Enterocolitis any stage, all- cause mortalityTimepoint: Daily till discharge or death;2.Duration of intravenous fluid use (in days)Timepoint: Daily till discharge or death;3.Time in days to regain birth weight & weight gain in grams per kg per day at one month of ageTimepoint: Daily till discharge or death;4.Total duration of hospital stays (in days)Timepoint: Daily till discharge or death;5.Proportion of extrauterine growth retardationTimepoint: Daily till discharge or death