Clinical trial NCT05551975: Preterm Infants Fed a Human Milk Fortifier
Official title: Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Growth
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 5-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).
* Confirmed current sepsis.
* 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.
* Participant has an allergy or intolerance to any ingredient in study fortifier.

Primary outcomes:
measure: Weight
timeFrame: Study Day 1 to Study Day 29 or Hospital Discharge if first
Secondary outcomes:
measure: Length
timeFrame: Study Day 1 to Study Day 15 and Study Day 29
measure: Length
timeFrame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
measure: Head Circumference
timeFrame: Study Day 1 to Study Day 15 and Study Day 29
measure: Head Circumference (HC)
timeFrame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
measure: Weight
timeFrame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
measure: Weight
timeFrame: Study Day 1 to Study Day 15
measure: Stool Characteristics
timeFrame: Study Day 1 to Study Day 29
measure: Feeding Intolerance
timeFrame: Study Day 1 to Study Day 29
measure: Full Enteral Feeds
timeFrame: Study Day 1 to Study Day 29
Other outcomes:
measure: Blood Chemistries
timeFrame: Study Day 1 to Study Day 29
measure: Medications
timeFrame: Study Day 1 to Study Day 29
measure: Length of Stay
timeFrame: From birth until Discharge, typically 60 days
measure: Stool Sample
timeFrame: Study Day 1 to Study Day 29
measure: Blood Sample for Immunity/Inflammation
timeFrame: Study Day 1 to Study Day 29
measure: Adverse Events
timeFrame: Study Day 1 until Discharge, typically 60 days
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center
state: Arizona
city: Little Rock
country: United States
facility: UAMS Medical Center
state: Arkansas
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Children's Hospital
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: San Antonio
country: United States
facility: St. Luke's Baptist Hospital
state: Texas
city: Morgantown
country: United States
facility: WVU Medicine Children's Hospital
state: West Virginia
Study officials:
affiliation: Abbott Nutrition
name: Elizabeth Reverri, PhD, MS, RD
role: STUDY_CHAIR
References: