Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
Primary Purpose
Enteral Nutrition, Born Very Premature, Infant, Very Low Birth Weight
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
nutrition
Sponsored by
About this trial
This is an interventional other trial for Enteral Nutrition focused on measuring feeding intolerance, minimal enteral nutrition, very low birth weight, preterm infant
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
Sites / Locations
- Zekai Tahir Burak Women's Health and Education Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
group 1
group 2
Arm Description
prolonged minimal enteral nutrition
slowly advancing enteral nutrition
Outcomes
Primary Outcome Measures
incidence of feeding intolerance
incidence of feeding intolerance
time to reach full enteral feedings sustained for 72 hours.
Secondary Outcome Measures
Full Information
NCT ID
NCT02913677
First Posted
August 15, 2016
Last Updated
January 13, 2018
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02913677
Brief Title
Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Nutrition, Born Very Premature, Infant, Very Low Birth Weight
Keywords
feeding intolerance, minimal enteral nutrition, very low birth weight, preterm infant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
prolonged minimal enteral nutrition
Arm Title
group 2
Arm Type
Placebo Comparator
Arm Description
slowly advancing enteral nutrition
Intervention Type
Dietary Supplement
Intervention Name(s)
nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of feeding intolerance
Description
incidence of feeding intolerance
Time Frame
28 days
Title
time to reach full enteral feedings sustained for 72 hours.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Zekai Tahir Burak Women's Health and Education Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
31994953
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.
Results Reference
derived
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Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
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