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Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Primary Purpose

Preterm Infants

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Experimental human milk fortifier
Control human milk fortifier
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infants

Eligibility Criteria

undefined - 21 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 700-1500g birth weight
  • 33 weeks or less gestational age
  • Appropriate for gestational age
  • Initiate enteral feeds of human milk by 21 days of life
  • Mother provided exclusive human milk feeds
  • Parents allow both human milk and study human milk fortifier
  • Singleton or twin birth

Exclusion Criteria:

  • Feeding preterm infant formula or non-study human milk fortifier
  • Expected at facility less than 15 days
  • Congenital anomalies/disease affecting growth and development
  • 5 minute APGAR of 4 or less
  • Steroid use
  • ECMO
  • Grade III or IV PVH/IVH
  • Mechanical ventilator dependency
  • Maternal incapacity
  • History of major surgery
  • Asphyxia
  • Confirmed NEC or sepsis
  • Use of probiotics

Sites / Locations

  • University of Alabama
  • UCSD Medical Center
  • University South Florida
  • Memorial Hospital of Southbend
  • Wesley Medical Center
  • King's County Hospital Center
  • Cohen Children's Medical Center of New York at North Shore
  • Cohen Children's Medical Center of NY at North Shore
  • Childrens Hospital Westchester Medical Center
  • University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
  • MetroHealth Medical Center
  • Toledo Children's Hospital
  • OHSU
  • Lehigh Valley Health Network
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Human Milk Fortifier

Control Human Milk Fortifier

Arm Description

Experimental human milk fortifier to be added to human milk

Control human milk fortifier to be added to human milk

Outcomes

Primary Outcome Measures

Weight gain

Secondary Outcome Measures

Anthropometric variables
Length and head circumference
GI tolerance
stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.

Full Information

First Posted
June 8, 2011
Last Updated
February 19, 2013
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01373073
Brief Title
Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Official Title
Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Human Milk Fortifier
Arm Type
Experimental
Arm Description
Experimental human milk fortifier to be added to human milk
Arm Title
Control Human Milk Fortifier
Arm Type
Active Comparator
Arm Description
Control human milk fortifier to be added to human milk
Intervention Type
Other
Intervention Name(s)
Experimental human milk fortifier
Intervention Description
Human milk fortifier to be added to human milk feedings
Intervention Type
Other
Intervention Name(s)
Control human milk fortifier
Intervention Description
Control human milk fortifier to be added to human milk
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Anthropometric variables
Description
Length and head circumference
Time Frame
29 days
Title
GI tolerance
Description
stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.
Time Frame
29 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 700-1500g birth weight 33 weeks or less gestational age Appropriate for gestational age Initiate enteral feeds of human milk by 21 days of life Mother provided exclusive human milk feeds Parents allow both human milk and study human milk fortifier Singleton or twin birth Exclusion Criteria: Feeding preterm infant formula or non-study human milk fortifier Expected at facility less than 15 days Congenital anomalies/disease affecting growth and development 5 minute APGAR of 4 or less Steroid use ECMO Grade III or IV PVH/IVH Mechanical ventilator dependency Maternal incapacity History of major surgery Asphyxia Confirmed NEC or sepsis Use of probiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget Barrett-Reis, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-7335
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8774
Country
United States
Facility Name
University South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Memorial Hospital of Southbend
City
Southbend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
King's County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Cohen Children's Medical Center of New York at North Shore
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Cohen Children's Medical Center of NY at North Shore
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Childrens Hospital Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26488118
Citation
Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010. Erratum In: J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):188-9.
Results Reference
derived

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Evaluation of a Novel Human Milk Fortifier in Preterm Infants

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