Evaluation of a Novel Human Milk Fortifier in Preterm Infants

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

Study Overview

• Status: Completed
• Conditions: Preterm Infants
• Intervention / Treatment: Other: Experimental human milk fortifier; Other: Control human milk fortifier

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249-7335
      • University of Alabama
  • California
    • San Diego, California, United States, 92103-8774
      • UCSD Medical Center
  • Florida
    • Tampa, Florida, United States, 33606
      • University South Florida
  • Indiana
    • Southbend, Indiana, United States, 46601
      • Memorial Hospital of Southbend
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center
  • New York
    • Brooklyn, New York, United States, 11203
      • King's County Hospital Center
    • Manhasset, New York, United States, 11030
      • Cohen Children's Medical Center of New York at North Shore
    • New Hyde Park, New York, United States, 11040
      • Cohen Children's Medical Center of NY at North Shore
    • Valhalla, New York, United States, 10595
      • Childrens Hospital Westchester Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
    • Toledo, Ohio, United States, 43606
      • Toledo Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Human Milk Fortifier; Experimental human milk fortifier to be added to human milk	Other: Experimental human milk fortifier; Human milk fortifier to be added to human milk feedings
Active Comparator: Control Human Milk Fortifier; Control human milk fortifier to be added to human milk	Other: Control human milk fortifier; Control human milk fortifier to be added to human milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight gain	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric variables	Length and head circumference	29 days
GI tolerance	stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.	29 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 19, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: AK37