Preterm Infants Fed a Human Milk Fortifier

NCT05551975 | Not Yet Recruiting DMC

• 1 other identifier: AL46
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 14

Brief Summary

This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight gain per day

  Study Day 1 to Study Day 29 or Hospital Discharge if first

Secondary Outcomes (9)

• Length

  Study Day 1 to Study Day 15 and Study Day 29

• Length

  Study Day 1, 8, 15, 22, 29 and Hospital Discharge

• Head Circumference

  Study Day 1 to Study Day 15 and Study Day 29

• Head Circumference (HC)

  Study Day 1, 8, 15, 22, 29 and Hospital Discharge

• Weight

  Study Day 1, 8, 15, 22, 29 and Hospital Discharge

Other Outcomes (6)

• Blood Chemistries

  Study Day 1 to Study Day 29

• Medications

  Study Day 1 to Study Day 29

• Length of Stay

  From birth until Discharge, typically 60 days

Study Arms (3)

Control Product

ACTIVE COMPARATOR

Control Human Milk Fortifier added to human milk feedings

Other: Control Product

Product 1

EXPERIMENTAL

Study Human Milk Fortifier added to human milk feedings

Other: Experimental Product 1

Product 2

EXPERIMENTAL

Study Human Milk Fortifier added to human milk feedings

Other: Experimental Product 2

Interventions

Control Product OTHER

Fed from Study Day 1

Control Product

Experimental Product 1 OTHER

Fed from Study Day 1

Product 1

Experimental Product 2 OTHER

Fed from Study Day 1

Product 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Birth weight between 700 g-1500 g.
• ≤ 32 weeks and 0 days GA at birth.
• Participant has been classified as appropriate for GA (AGA).
• Enteral feeding of human milk must be 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 fortified with study fortifier and use of mother's own milk (when available) is prioritized.
• Parent(s) agrees to allow infant to receive both human milk and study HMF.
• Singleton or twin births only.
• Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

You may not qualify if:

• Enteral feeding of preterm infant formula or HMF for \> 7 days.
• Expected to be transferred to another facility within 30 days of randomization.
• Serious congenital abnormalities or underlying disease that may affect growth and development.
• minute APGAR ≤ 4.
• Receiving systemic steroids at time of randomization.
• Receiving probiotics at time of randomization.
• Grade Ill or IV PVH/IVH.
• Dependent on invasive ventilation at time of randomization.
• Maternal incapacity.
• Mother or infant is currently receiving treatment consistent with HIV therapy.
• Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse.
• Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant.
• 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.
• Confirmed NEC (Bell's Stage II or III).

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (14)

Banner - University Medical Center

Phoenix, Arizona, 85006, United States

Location

UAMS Medical Center

Little Rock, Arkansas, 72205, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

South Miami Hospital

Miami, Florida, 33143, United States

Location

AdventHealth

Orlando, Florida, 32803, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of New Mexico Children's Hospital

Albuquerque, New Mexico, 87106, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Woman's Hospital of Texas

Houston, Texas, 77054, United States

Location

St. Luke's Baptist Hospital

San Antonio, Texas, 78229, United States

Location

WVU Medicine Children's Hospital

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Elizabeth Reverri, PhD, MS, RD

  Abbott Nutrition

  STUDY CHAIR

Central Study Contacts

Kristen S DeLuca, MS, RDN, LDN

CONTACT

614-645-5455; kristen.deluca@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 23, 2022
• Study Start: September 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)