Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913677
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Condition or disease Intervention/treatment Phase
Enteral Nutrition Born Very Premature Infant, Very Low Birth Weight Dietary Supplement: nutrition Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
Active Comparator: group 1
prolonged minimal enteral nutrition
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.

Placebo Comparator: group 2
slowly advancing enteral nutrition
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.




Primary Outcome Measures :
  1. incidence of feeding intolerance [ Time Frame: 28 days ]
    incidence of feeding intolerance

  2. time to reach full enteral feedings sustained for 72 hours. [ Time Frame: 72 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   23 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913677


Locations
Layout table for location information
Turkey
Zekai Tahir Burak Women's Health and Education Hospital
Ankara, Turkey, 06230
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02913677    
Other Study ID Numbers: ZTB7915
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: August 2016
Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
feeding intolerance
minimal enteral nutrition
very low birth weight
preterm infant
Additional relevant MeSH terms:
Layout table for MeSH terms
Birth Weight
Body Weight