Clinical trial NCT02913677: Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Born Very Premature
Infant, Very Low Birth Weight
Keywords: feeding intolerance
minimal enteral nutrition
very low birth weight
preterm infant
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 199
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those \<1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.

Detailed description: Background: Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those \<1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.

Aim: To assess the effects of two different feeding strategies in very low birth weight preterm infants with birth weight ≤1250 gr and gestational age ≤32 weeks on the incidence of feeding intolerance and time to reach full enteral feedings.

Study design: prospective randomized controlled trial comparing the effects of prolonged minimal enteral nutrition (MEN) with progressive advancing enteral feedings.

Primary outcomes: incidence of feeding intolerance and time to reach full enteral feedings sustained for 72 hours.

Secondary outcomes: incidence of NEC, sepsis, duration of hospitalization Methods: a total of 200 preterm infants with gestational age ≤32 weeks and birthweight ≤1250 gr were randomly allocated to one of the 2 feeding strategies.

Group 1-) Feeding was started in the first 48 hours. Fed with 10-15 ml/kg/d MEN for 5 days and than feed volumes were advanced by 20-25 ml/kg/d until 150ml/kg/d feed volume was achieved.

Group 2-) Feeding was started in the first 48 hours with a volume of 10-15 ml/kg/d and advanced with daily increments of 20-25 ml/kg/d until 150 ml/kg/d feed volume was achieved.

MEN was withheld when the infant developped NEC or when there was bilious emesis or gross blood in stool.

Feeding intolerance was defined as; Bilious emesis or gastric residuals Grossly bloody stools, Abdominal tenderness or discoloration, Gastric residuals in ≥%50 of previous feed volume Emesis ≥3 times in 8 hours period Clinical or radiological evidence of NEC When feeding intolerance was developped feeds were withheld in both groups until the problem was resolved and resumed feed volume where withheld.

In the study unit parenteral nutrition was started on the first day of birth. Parenteral nutrition volume was decreased as the enteral feeds increased. Breast milk was the first choice for enteral nutrition if available but if not preterm formulas were used. When 100ml/kg/d enteral feed volume was achieved breast milk was fortified with Euprotin as a standard procedure.

Eligibility criteria: Inclusion Criteria:

* gestational age≤32 weeks and birthweight ≤1250 gr, and \<48 hours postnatal age

Exclusion Criteria:

* Major congenital and/or chromosomal anomaly, Cyanotic congenital heart disease, Asphyxiated birth with pH \<7.0 and base deficit ≥16mmol/l Severe cardiopulmonary compromise or multiorgan failure Twin-twin transfusion, Those died in postnatal 5 days of age

Primary outcomes:
measure: incidence of feeding intolerance
timeFrame: 28 days
measure: time to reach full enteral feedings sustained for 72 hours.
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Women's Health and Education Hospital
Study officials:
References:
citation: Bozkurt O, Alyamac Dizdar E, Bidev D, Sari FN, Uras N, Oguz SS. Prolonged minimal enteral nutrition versus early feeding advancements in preterm infants with birth weight </=1250 g: a prospective randomized trial. J Matern Fetal Neonatal Med. 2022 Jan;35(2):341-347. doi: 10.1080/14767058.2020.1716723. Epub 2020 Jan 29.