Back to resultsEarly Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants (ENACT+)
Primary Purpose
Prematurity, Light-For-Dates, Enteral Feeding Intolerance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early HMF
Delayed HMF
Sponsored by
About this trial
This is an interventional prevention trial for Prematurity
Eligibility Criteria
Inclusion Criteria:
- Gestational age 29 to 33 weeks of gestation
- Birth weight < 1800 g
- Postnatal age < 96 hours
Exclusion Criteria:
- Small for gestational age (<5th percentile)
- Major congenital/chromosomal anomalies
- Terminal illness needing withhold or limit support
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early human milk fortification (HMF) group
Delayed human milk fortification (HMF) group
Arm Description
A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.
A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.
Outcomes
Primary Outcome Measures
Fat-free mass(FFM)-for-age Z-score
Estimated by air displacement plethysmography
Secondary Outcome Measures
Fecal microbiome composition
Determined by 16S RNA sequencing of bacteria in stool samples
Growth - Weight
Measured weekly in grams and z scores as part of routine care
Growth - Length
Measured weekly in cm and z scores as part of routine care
Growth - Head circumference
Measured weekly in cm and z scores as part of routine care
Growth rate
Weight gain in g/kg/day
Number of participants with postnatal growth faltering
Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2
Number of participants with diagnosis of necrotizing enterocolitis
Diagnosis of necrotizing enterocolitis stage 2 or 3
Number of participants with diagnosis of intestinal perforation
Diagnosis of intestinal perforation
Death
Death prior to postnatal day 60
Duration of hospital stay in days
From day of admission to day of hospital discharge to home
Full Information
NCT ID
NCT05525585
First Posted
August 29, 2022
Last Updated
September 28, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Mead Johnson Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT05525585
Brief Title
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Acronym
ENACT+
Official Title
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Mead Johnson Nutrition
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Light-For-Dates, Enteral Feeding Intolerance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early human milk fortification (HMF) group
Arm Type
Experimental
Arm Description
A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.
Arm Title
Delayed human milk fortification (HMF) group
Arm Type
Active Comparator
Arm Description
A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.
Intervention Type
Dietary Supplement
Intervention Name(s)
Early HMF
Intervention Description
Mom's milk or donor milk will be fortified between postnatal day 4 and 7
Intervention Type
Dietary Supplement
Intervention Name(s)
Delayed HMF
Intervention Description
Mom's milk or donor milk will be fortified between postnatal day 10 and 14
Primary Outcome Measure Information:
Title
Fat-free mass(FFM)-for-age Z-score
Description
Estimated by air displacement plethysmography
Time Frame
Postnatal day 14 to 21
Secondary Outcome Measure Information:
Title
Fecal microbiome composition
Description
Determined by 16S RNA sequencing of bacteria in stool samples
Time Frame
Birth to 36 weeks postmenstrual age
Title
Growth - Weight
Description
Measured weekly in grams and z scores as part of routine care
Time Frame
Birth to 36 weeks postmenstrual age or hospital discharge
Title
Growth - Length
Description
Measured weekly in cm and z scores as part of routine care
Time Frame
Birth to 36 weeks postmenstrual age or hospital discharge
Title
Growth - Head circumference
Description
Measured weekly in cm and z scores as part of routine care
Time Frame
Birth to 36 weeks postmenstrual age or hospital discharge
Title
Growth rate
Description
Weight gain in g/kg/day
Time Frame
Birth to 36 weeks postmenstrual age or hospital discharge
Title
Number of participants with postnatal growth faltering
Description
Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2
Time Frame
Birth to 36 weeks postmenstrual age or hospital discharge
Title
Number of participants with diagnosis of necrotizing enterocolitis
Description
Diagnosis of necrotizing enterocolitis stage 2 or 3
Time Frame
Birth to 60 days or discharge
Title
Number of participants with diagnosis of intestinal perforation
Description
Diagnosis of intestinal perforation
Time Frame
Birth to 10 days
Title
Death
Description
Death prior to postnatal day 60
Time Frame
Birth to 60 days
Title
Duration of hospital stay in days
Description
From day of admission to day of hospital discharge to home
Time Frame
Birth to 60 days or discharge, whichever occurs first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age 29 to 33 weeks of gestation
Birth weight < 1800 g
Postnatal age < 96 hours
Exclusion Criteria:
Small for gestational age (<5th percentile)
Major congenital/chromosomal anomalies
Terminal illness needing withhold or limit support
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel A. Salas, MD, MSPH
Phone
205-934-4680
Email
asalas@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel A. Salas, MD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel A. Salas, MD, MSPH
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
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