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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
183
This group will receive enteral feeding volumes at a rate 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.
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.
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, India
Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth
Days to attain full feeds during the first 28 days after birth
Time frame: Birth to 28 days
Number of episodes of feeding intolerance
Feed intolerance will be defined as any one or more of the following a) Vomiting 3 or more in any 24 hour period, b) Any episode of blood stained or bilious vomiting, c) Abdominal girth(AG) increase \>2 cm (with pre-feed aspirate \>25%), abdominal wall erythema or tenderness, gross or occult blood in stools
Time frame: From Randomization till 28 days after birth
Incidence of Necrotising Enterocolitis
Diagnosis of necrotizing enterocolitis any stage
Time frame: From Randomization till 28 days after birth
Incidence of Sepsis
Sepsis will be defined as any one of the following in a symptomatic neonate a) Culture positive sepsis b) Sepsis screen positive, c) Strong clinical suspicion such as sclerema, shock or clinical deterioration on supportive therapy which warrants initiation of antibiotics (clinician decision)
Time frame: From randomization till 28 days after birth
Total duration of intravenous fluid usage
Duration in completed days for which infant required parenteral fluid support
Time frame: From randomization till 28 days after birth
Time of regaining birth weight
Duration in completed days required to regain birth weight
Time frame: From randomization till 28 days after birth
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Total duration of hospital stay
Duration in completed days required for treatment till discharge home or till death
Time frame: From randomization till 2 months after birth
Weight gain per kg per day at 1 month of age
The weight in grams at one month of age minus the birth weight divided by the average weight (average weight =birth weight +Weight at 1 month age divided by 2) further divided by 30
Time frame: Birth to 30 days
Extrauterine growth retardation (EUGR)
Weight of the infants at 36 weeks Postmenstrual age or at discharge (if earlier) below the 10th centile for age
Time frame: Till 36 weeks Postmenstrual age