ClinicalTrials.gg
Not yet recruitingNCT05551975Updated Jun 28, 2024

Preterm Infants Fed a Human Milk Fortifier

An interventional study of Control Product and Experimental Product 1 in Growth, sponsored by Abbott Nutrition. Not yet recruiting at 14 sites in United States. Per ClinicalTrials.gov, last updated 2024-06-28.

Sponsored by Abbott Nutrition (part of Abbott) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
321
Allocation
Randomized
Sex
All
01

Study 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).

02

Conditions studied

  • Growth
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
321 participants (estimated)

Study arms

  • Active comparator
    Control Product

    Control Human Milk Fortifier added to human milk feedings

    Other: Control Product

  • Experimental
    Product 1

    Study Human Milk Fortifier added to human milk feedings

    Other: Experimental Product 1

  • Experimental
    Product 2

    Study Human Milk Fortifier added to human milk feedings

    Other: Experimental Product 2

Interventions

  • OtherControl Product

    Fed from Study Day 1

  • OtherExperimental Product 1

    Fed from Study Day 1

  • OtherExperimental Product 2

    Fed from Study Day 1

06

What researchers measure

Primary outcomes

  1. Weight

    Weight gain per day

    Time frame: Study Day 1 to Study Day 29 or Hospital Discharge if first

Secondary outcomes

  1. Length

    Length gains per week

    Time frame: Study Day 1 to Study Day 15 and Study Day 29

  2. Length

    Attained length in cm

    Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge

  3. Head Circumference

    Head circumference gains per week

    Time frame: Study Day 1 to Study Day 15 and Study Day 29

  4. Head Circumference (HC)

    Attained HC in cm

    Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge

  5. Weight

    Attained weight in grams

    Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge

  6. Weight

    Weight gain per day

    Time frame: Study Day 1 to Study Day 15

  7. Stool Characteristics

    Percent bloody, black, watery, or hard stools

    Time frame: Study Day 1 to Study Day 29

  8. Feeding Intolerance

    Percent periods NPO, feedings withheld due to gastrointestinal intolerance

    Time frame: Study Day 1 to Study Day 29

  9. Full Enteral Feeds

    Days to achieve full enteral feeds

    Time frame: Study Day 1 to Study Day 29

Other outcomes

  1. Blood Chemistries

    Electrolytes, minerals, BUN, alkaline phosphatase

    Time frame: Study Day 1 to Study Day 29

  2. Medications

    Medication usage including frequency and reason for use

    Time frame: Study Day 1 to Study Day 29

  3. Length of Stay

    Number of days in hospital

    Time frame: From birth until Discharge, typically 60 days

  4. Stool Sample

    Characterization of microbiota, immunity

    Time frame: Study Day 1 to Study Day 29

  5. Blood Sample for Immunity/Inflammation

    Cytokines

    Time frame: Study Day 1 to Study Day 29

  6. Adverse Events

    Number of participants with adverse events (AEs) and concurrent expected events

    Time frame: Study Day 1 until Discharge, typically 60 days

07

Study locations

14 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05551975
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Sep 23, 2022
Start date
Sep 2024 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Jun 28, 2024

Study contacts

Kristen S DeLuca, MS, RDN, LDN
Contact
kristen.deluca@abbott.com
614-645-5455
Elizabeth Reverri, PhD, MS, RD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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