GrowthNCT05551975
Preterm Infants Fed a Human Milk Fortifier
A study testing Experimental Product 1 and Experimental Product 2 in people with Growth, run by Abbott Nutrition at 14 sites in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth
- What is being tested?
- Experimental Product 1 and Experimental Product 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites
University of New Mexico Children's Hospital
Albuquerque, New Mexico, 87106
Tufts Medical Center
Boston, Massachusetts, 02111
Duke University Medical Center
Durham, North Carolina, 27710
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
The Woman's Hospital of Texas
Houston, Texas, 77054
Children's Mercy Hospital
Kansas City, Missouri, 64108
UAMS Medical Center
Little Rock, Arkansas, 72205
North Shore University Hospital
Manhasset, New York, 11030
South Miami Hospital
Miami, Florida, 33143
WVU Medicine Children's Hospital
Morgantown, West Virginia, 26505
AdventHealth
Orlando, Florida, 32803
Banner - University Medical Center
Phoenix, Arizona, 85006
St. Luke's Baptist Hospital
San Antonio, Texas, 78229
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier
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
- Being tested
- Control Product, Experimental Product 1, Experimental Product 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control ProductOther
Fed from Study Day 1
Experimental Product 1Other
Fed from Study Day 1
Experimental Product 2Other
Fed from Study Day 1
| Study group | Role | What they receive |
|---|---|---|
| Control Product | Active comparator | Control Human Milk Fortifier added to human milk feedings Receives: Other: Control Product |
| Product 1 | Experimental | Study Human Milk Fortifier added to human milk feedings Receives: Other: Experimental Product 1 |
| Product 2 | Experimental | Study Human Milk Fortifier added to human milk feedings Receives: Other: Experimental Product 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight gain per day
Measured: Study Day 1 to Study Day 29 or Hospital Discharge if first
Secondary outcomes (9)
Length
Length gains per week
Measured: Study Day 1 to Study Day 15 and Study Day 29
Length
Attained length in cm
Measured: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Head Circumference
Head circumference gains per week
Measured: Study Day 1 to Study Day 15 and Study Day 29
Head Circumference (HC)
Attained HC in cm
Measured: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Attained weight in grams
Measured: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Weight gain per day
Measured: Study Day 1 to Study Day 15
Stool Characteristics
Percent bloody, black, watery, or hard stools
Measured: Study Day 1 to Study Day 29
Feeding Intolerance
Percent periods NPO, feedings withheld due to gastrointestinal intolerance
Measured: Study Day 1 to Study Day 29
Full Enteral Feeds
Days to achieve full enteral feeds
Measured: Study Day 1 to Study Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startSep 2024 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Reverri, PhD, MS, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551975
- Sponsor's protocol ID
- AL46
- Status last verified
- Jun 2024
- First submitted
- 1 Sep 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier
- ClinicalTrials.gov ID
- NCT05551975
- Acronym / sponsor ID
- AL46
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Product | Active comparator | Other: Control ProductControl Human Milk Fortifier added to human milk feedings |
| Product 1 | Experimental | Other: Experimental Product 1Study Human Milk Fortifier added to human milk feedings |
| Product 2 | Experimental | Other: Experimental Product 2Study Human Milk Fortifier added to human milk feedings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control ProductFed from Study Day 1 | Other | Control Product |
| Experimental Product 1Fed from Study Day 1 | Other | Product 1 |
| Experimental Product 2Fed from Study Day 1 | Other | Product 2 |
Primary outcome
Weight
Time frame: Study Day 1 to Study Day 29 or Hospital Discharge if first
Weight gain per day
9 secondary outcomes
Length
Time frame: Study Day 1 to Study Day 15 and Study Day 29
Length
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Head Circumference
Time frame: Study Day 1 to Study Day 15 and Study Day 29
Head Circumference (HC)
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Time frame: Study Day 1 to Study Day 15
Stool Characteristics
Time frame: Study Day 1 to Study Day 29
Feeding Intolerance
Time frame: Study Day 1 to Study Day 29
Full Enteral Feeds
Time frame: Study Day 1 to Study Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Reverri, PhD, MS, RD study chair
Abbott Nutrition
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Product 1 and Experimental Product 2 in people with Growth, run by Abbott Nutrition at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen S DeLuca, MS, RDN, LDN (614-645-5455, kristen.deluca@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Study Day 1 to Study Day 29 or Hospital Discharge if first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.