Preterm Infants Fed a Human Milk Fortifier

Growth Clinical Trial

Official title:

Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05551975
• Other study ID #: AL46
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: January 2028

Study information

• Verified date: March 2024
• Source: Abbott Nutrition
• Contact: Kristen S DeLuca, MS, RDN, LDN
• Phone: 614-645-5455
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 321
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Control Product
Fed from Study Day 1
• Experimental Product 1
Fed from Study Day 1
• Experimental Product 2
Fed from Study Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Chemistries	Electrolytes, minerals, BUN, alkaline phosphatase	Study Day 1 to Study Day 29
Other	Medications	Medication usage including frequency and reason for use	Study Day 1 to Study Day 29
Other	Length of Stay	Number of days in hospital	From birth until Discharge, typically 60 days
Other	Stool Sample	Characterization of microbiota, immunity	Study Day 1 to Study Day 29
Other	Blood Sample for Immunity/Inflammation	Cytokines	Study Day 1 to Study Day 29
Other	Adverse Events	Number of participants with adverse events (AEs) and concurrent expected events	Study Day 1 until Discharge, typically 60 days
Primary	Weight	Weight gain per day	Study Day 1 to Study Day 29 or Hospital Discharge if first
Secondary	Length	Length gains per week	Study Day 1 to Study Day 15 and Study Day 29
Secondary	Length	Attained length in cm	Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Secondary	Head Circumference	Head circumference gains per week	Study Day 1 to Study Day 15 and Study Day 29
Secondary	Head Circumference (HC)	Attained HC in cm	Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Secondary	Weight	Attained weight in grams	Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Secondary	Weight	Weight gain per day	Study Day 1 to Study Day 15
Secondary	Stool Characteristics	Percent bloody, black, watery, or hard stools	Study Day 1 to Study Day 29
Secondary	Feeding Intolerance	Percent periods NPO, feedings withheld due to gastrointestinal intolerance	Study Day 1 to Study Day 29
Secondary	Full Enteral Feeds	Days to achieve full enteral feeds	Study Day 1 to Study Day 29