Study to Compare Continuous Feeding with Bolus Feeding in Preterm Infants Equal to Or Less Than 1250 Grams
Phase 3
- Conditions
- Health Condition 1: P071- Other low birth weight newborn
- Registration Number
- CTRI/2023/12/060524
- Lead Sponsor
- AIIMS Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inborn infants between 600 and less than or equal to 1250 gram birth weight with the decision to start enteral feeding within 96 hours of birth
Exclusion Criteria
i)Major congenital malformations or suspected/proven syndromic infants
ii)Antenatally diagnosed surgical conditions prohibiting the start of enteral feed
iii)Suspected or confirmed gastrointestinal obstruction
iv)Severe perinatal asphyxia (Apgar < 3 at birth)
v)Less than 600 gram birth weight
vi)No reasonable chance of survival
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to reach full feed (150 ml/kg/day for at least 48 hours) between the continuous followed by intermittent feeding group and the intermittent feeding group in less than or equal to 1250 gram infants.Timepoint: Day of life at which the enrolled infant achieves 150 ml/kg/day feed or more (for at least 48 hours)
- Secondary Outcome Measures
Name Time Method 1.Incidence of feed intolerance <br/ ><br>2.Incidence of necrotizing enterocolitis stage 2 or more <br/ ><br>3.Time to regain birth weight <br/ ><br>4.All cause mortality(In hospital) <br/ ><br>5.Anthropometry at discharge (Weight, length, Occipitofrontal circumference) <br/ ><br>6.Duration of hospital stay(in days) <br/ ><br>7.Incidence of Bronchopulmonary dysplasia <br/ ><br>8.PDA requiring medical and or surgical treatment <br/ ><br>9.ROP any stage <br/ ><br>10.ROP requiring Laser or Anti VEGF or both <br/ ><br>11.IVH any grade and severe grade ( grade 3 and grade 3 with parenchymal extension) <br/ ><br>12.Incidence of Periventricular leukomalacia <br/ ><br>13.Episodes of Culture positive sepsis <br/ ><br>14.Episodes of Culture negative sepsis <br/ ><br>15.Survival without major morbidity <br/ ><br>Timepoint: till diacharge or death of the enrolled infant