Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Neonates Between 27 to 32 Weeks of Gestation: A Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Very Preterm Maturity of Infant
- Sponsor
- Lady Hardinge Medical College
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF).
Detailed Description
Enrolled participants will be randomly assigned to one of two study groups: 1) early total enteral feeding (ETEF) or 2) conventional enteral feeding (CEF). Regardless of study group assignment, mother's own breast milk (MOM) is the feed of choice and donor human milk is being offered if the MOM is not enough to complete the intervention as assigned Intervention group: Feeds will be initiated with a target volume of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5. Control group: This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.
Investigators
Sushma Nangia, M.D.
Dr Sushma Nangia, Director Professor & Head, Neonatology
Lady Hardinge Medical College
Eligibility Criteria
Inclusion Criteria
- •Preterm neonate with gestational age of 27-32 weeks
Exclusion Criteria
- •Antenatally diagnosed GI malformation
- •Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler.
- •Presence of major congenital anomalies at birth
- •Need of vasopressor support at the time of randomization
- •Requiring Positive Pressure Ventilation \> 60 sec with APGAR score \< 4 at 1 minute
Outcomes
Primary Outcomes
Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth
Time Frame: Birth to 28 days
Days to attain full feeds during the first 28 days after birth
Secondary Outcomes
- Number of episodes of feeding intolerance(From Randomization till 28 days after birth)
- Incidence of Sepsis(From randomization till 28 days after birth)
- Incidence of Necrotising Enterocolitis(From Randomization till 28 days after birth)
- Time of regaining birth weight(From randomization till 28 days after birth)
- Weight gain per kg per day at 1 month of age(Birth to 30 days)
- Total duration of intravenous fluid usage(From randomization till 28 days after birth)
- Total duration of hospital stay(From randomization till 2 months after birth)
- Extrauterine growth retardation (EUGR)(Till 36 weeks Postmenstrual age)