Evaluation of Human Milk Fortifiers in Preterm Infants

Evaluation of Two Human Milk Fortifiers in Preterm Infants

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.

Study Overview

• Status: Completed
• Conditions: Infant Growth
• Intervention / Treatment: Other: Human Milk Fortifier A; Other: Human Milk Fortifier B

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama Children's and Women's Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Banner - University Medical Center Phoenix
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8064
      • Yale University
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Miami, Florida, United States, 33143
      • South Miami Hospital
    • Saint Petersburg, Florida, United States, 33701
      • All Children's Hospital / Johns Hopkins
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • Manhasset, New York, United States, 11030
      • Cohen Children's Medical Center of NY at North Shore
    • New Hyde Park, New York, United States, 11040
      • Cohen Children's Medical Center of NY
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
  • Texas
    • Edinburg, Texas, United States, 78539
      • Doctors Hospital at Renaissance/Women's Hospital at Renaissance
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
    • Fort Worth, Texas, United States, 76104
      • Texas Health and Education Institute
    • San Antonio, Texas, United States, 78258
      • North Central Baptist Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • Wheaton Franciscan Heathcare Inc.- St. Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Birth weight of 700 g-1500 g.
• ≤ 32 weeks and 0 days GA at birth.
• Appropriate for GA (AGA).
• Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).
• Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.
• Parent(s) agrees to allow infant to receive both human milk and HMF.
• Singleton or twin births only.

Exclusion Criteria:

• Enteral feeding of preterm infant formula or HMF for > 7 days.
• Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
• Serious congenital abnormalities or underlying disease that may affect growth and development.
• 5 minute APGAR ≤ 4.
• Steroids used at the time of randomization.
• Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
• Mechanical ventilator dependence.
• Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
• Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
• Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).
• Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
• Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
• Participation in another study that has not been approved as a concomitant study by AN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Study Human Milk Fortifier A; Acidified processing method.	Other: Human Milk Fortifier A; Acidified concentrated liquid human milk fortifier
EXPERIMENTAL: Study Human Milk Fortifier B; Non-acidified processing method.	Other: Human Milk Fortifier B; Non-acidified concentrated liquid human milk fortifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain	scale measurement g/kg/d	Study Day 1 to Study Day 29 (or discharge, whichever happens first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Tolerance	healthcare professional completed questionnaire	Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Length	measured cm/wk	Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Head Circumference	measured cm/wk	Study Day 1 to Study Day 29 (or discharge, whichever happens first)

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Bridget Barrett-Reis, PhD, RD, Abbott Nutrition

Publications and helpful links

General Publications

• Paul M, Partridge J, Barrett-Reis B, Ahmad KA, Machiraju P, Jayapalan H, Schanler RJ. Metabolic Acidosis in Preterm Infants is Associated with a Longer Length of Stay in the Neonatal Intensive Care Unit. Pharmacoecon Open. 2020 Sep;4(3):541-547. doi: 10.1007/s41669-020-00194-y.
• Schanler RJ, Groh-Wargo SL, Barrett-Reis B, White RD, Ahmad KA, Oliver J, Baggs G, Williams L, Adamkin D. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018 Nov;202:31-37.e2. doi: 10.1016/j.jpeds.2018.07.005. Epub 2018 Sep 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2014
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (ESTIMATE): December 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AL16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED