Growth
Conditions
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).
Interventions
OTHERControl Product
Fed from Study Day 1
OTHERExperimental Product 1
Fed from Study Day 1
OTHERExperimental Product 2
Fed from Study Day 1
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Study Day 1 to Study Day 29 or Hospital Discharge if first | Weight gain per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head Circumference | Study Day 1 to Study Day 15 and Study Day 29 | Head circumference gains per week |
| Length | Study Day 1 to Study Day 15 and Study Day 29 | Length gains per week |
| Head Circumference (HC) | Study Day 1, 8, 15, 22, 29 and Hospital Discharge | Attained HC in cm |
| Weight | Study Day 1, 8, 15, 22, 29 and Hospital Discharge | Attained weight in grams |
| Stool Characteristics | Study Day 1 to Study Day 29 | Percent bloody, black, watery, or hard stools |
| Feeding Intolerance | Study Day 1 to Study Day 29 | Percent periods NPO, feedings withheld due to gastrointestinal intolerance |
| Full Enteral Feeds | Study Day 1 to Study Day 29 | Days to achieve full enteral feeds |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | From birth until Discharge, typically 60 days | Number of days in hospital |
| Stool Sample | Study Day 1 to Study Day 29 | Characterization of microbiota, immunity |
| Blood Sample for Immunity/Inflammation | Study Day 1 to Study Day 29 | Cytokines |
| Adverse Events | Study Day 1 until Discharge, typically 60 days | Number of participants with adverse events (AEs) and concurrent expected events |
| Medications | Study Day 1 to Study Day 29 | Medication usage including frequency and reason for use |
| Blood Chemistries | Study Day 1 to Study Day 29 | Electrolytes, minerals, BUN, alkaline phosphatase |
Countries
United States
Contacts
Primary ContactKristen S DeLuca, MS, RDN, LDN
Outcome results
None listed