Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:

Enteral Nutrition Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913677
• Other study ID #: ZTB7915
• Status: Completed
• Phase: N/A
• First received: August 15, 2016
• Last updated: January 13, 2018
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2016
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Born Very Premature
• Enteral Nutrition
• Infant, Very Low Birth Weight

Intervention

Dietary Supplement:
• nutrition
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.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Women's Health and Education Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of feeding intolerance	incidence of feeding intolerance	28 days
Primary	time to reach full enteral feedings sustained for 72 hours.		72 hours