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

NCT02913677 | Completed

• 1 other identifier: ZTB7915
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

feeding intolerance; minimal enteral nutrition; very low birth weight; preterm infant

Outcome Measures

Primary Outcomes (2)

• incidence of feeding intolerance

  incidence of feeding intolerance

  28 days

• time to reach full enteral feedings sustained for 72 hours.

  72 hours

Study Arms (2)

group 1

ACTIVE COMPARATOR

prolonged minimal enteral nutrition

Dietary Supplement: nutrition

group 2

PLACEBO COMPARATOR

slowly advancing enteral nutrition

Dietary Supplement: nutrition

Interventions

nutrition DIETARY_SUPPLEMENT

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 1; group 2

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Women's Health and Education Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31994953 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2016-08

Locations

TU (1)