Infant GrowthNCT02307760
Evaluation of Human Milk Fortifiers in Preterm Infants
A study testing Human Milk Fortifier A and Human Milk Fortifier B in people with Infant Growth, run by Abbott Nutrition at 18 sites in United States.
Trial summary
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant Growth
- What is being tested?
- Human Milk Fortifier A and Human Milk Fortifier B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 18 sitesUnited States
- Study dates
- Dec 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 of 700 g-1500 g.
- ≤ 32 weeks and 0 days GA at birth.
- Appropriate for GA (AGA).
- Enteral feeding of human milk 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 the plan is that it will be fortified.
- Parent(s) agrees to allow infant to receive both human milk and HMF.
- Singleton or twin births only.
Who cannot join
- Enteral feeding of preterm infant formula or HMF for > 7 days.
- Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
- Serious congenital abnormalities or underlying disease that may affect growth and development.
- 5 minute APGAR ≤ 4.
- Steroids used at the time of randomization.
- Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
Show all 13Show fewer
- Mechanical ventilator dependence.
- Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
- 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 (24).
- Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
MetroHealth Medical Center
Cleveland, Ohio, 44109
Duke University Medical Center
Durham, North Carolina, 27710
Doctors Hospital at Renaissance/Women's Hospital at Renaissance
Edinburg, Texas, 78539
Cook Children's Medical Center
Fort Worth, Texas, 76104
Texas Health and Education Institute
Fort Worth, Texas, 76104
University of Louisville
Louisville, Kentucky, 40202
Cohen Children's Medical Center of NY at North Shore
Manhasset, New York, 11030
South Miami Hospital
Miami, Florida, 33143
Wheaton Franciscan Heathcare Inc.- St. Joseph
Milwaukee, Wisconsin, 53210
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, 36604
Yale University
New Haven, Connecticut, 06520-8064
Cohen Children's Medical Center of NY
New Hyde Park, New York, 11040
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85014
North Central Baptist Hospital
San Antonio, Texas, 78258
Memorial Hospital of South Bend
South Bend, Indiana, 46601
All Children's Hospital / Johns Hopkins
St. Petersburg, Florida, 33701
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Evaluation of Two Human Milk Fortifiers in Preterm Infants
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
- Conditions
- Infant Growth
- Being tested
- Human Milk Fortifier A, Human Milk Fortifier B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Milk Fortifier AOther
Acidified concentrated liquid human milk fortifier
Human Milk Fortifier BOther
Non-acidified concentrated liquid human milk fortifier
| Study group | Role | What they receive |
|---|---|---|
| Study Human Milk Fortifier A | Active comparator | Acidified processing method. Receives: Other: Human Milk Fortifier A |
| Study Human Milk Fortifier B | Experimental | Non-acidified processing method. Receives: Other: Human Milk Fortifier B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
scale measurement g/kg/d
Measured: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Secondary outcomes (3)
Gastrointestinal Tolerance
healthcare professional completed questionnaire
Measured: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Length
measured cm/wk
Measured: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Head Circumference
measured cm/wk
Measured: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant 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
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridget Barrett-Reis, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307760
- Sponsor's protocol ID
- AL16
- Status last verified
- May 2017
- First submitted
- 1 Dec 2014
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Paul M, Partridge J, Barrett-Reis B, Ahmad KA, Machiraju P, Jayapalan H, Schanler RJ. Metabolic Acidosis in Preterm Infants is Associated with a Longer Length of Stay in the Neonatal Intensive Care Unit. Pharmacoecon Open. 2020 Sep;4(3):541-547. doi: 10.1007/s41669-020-00194-y.
PubMed 31975350Schanler RJ, Groh-Wargo SL, Barrett-Reis B, White RD, Ahmad KA, Oliver J, Baggs G, Williams L, Adamkin D. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018 Nov;202:31-37.e2. doi: 10.1016/j.jpeds.2018.07.005. Epub 2018 Sep 5.
PubMed 30195561
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Human Milk Fortifiers in Preterm Infants
- ClinicalTrials.gov ID
- NCT02307760
- Acronym / sponsor ID
- AL16
- Conditions
- Infant Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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.
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Human Milk Fortifier A | Active comparator | Other: Human Milk Fortifier AAcidified processing method. |
| Study Human Milk Fortifier B | Experimental | Other: Human Milk Fortifier BNon-acidified processing method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Birth weight of 700 g-1500 g.
- ≤ 32 weeks and 0 days GA at birth.
- Appropriate for GA (AGA).
- Enteral feeding of human milk 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 the plan is that it will be fortified.
Key exclusion criteria (13 listed)
- Enteral feeding of preterm infant formula or HMF for > 7 days.
- Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
- Serious congenital abnormalities or underlying disease that may affect growth and development.
- 5 minute APGAR ≤ 4.
- Steroids used at the 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 |
|---|---|---|
| Human Milk Fortifier AAcidified concentrated liquid human milk fortifier | Other | Study Human Milk Fortifier A |
| Human Milk Fortifier BNon-acidified concentrated liquid human milk fortifier | Other | Study Human Milk Fortifier B |
Primary outcome
Weight Gain
Time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
scale measurement g/kg/d
3 secondary outcomes
Gastrointestinal Tolerance
Time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Length
Time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Head Circumference
Time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 31975350Paul M, Partridge J, Barrett-Reis B, Ahmad KA, Machiraju P, Jayapalan H, Schanler RJ. Metabolic Acidosis in Preterm Infants is Associated with a Longer Length of Stay in the Neonatal Intensive Care Unit. Pharmacoecon Open. 2020 Sep;4(3):541-547. doi: 10.1007/s41669-020-00194-y.
- Derived from this study: PubMed 30195561Schanler RJ, Groh-Wargo SL, Barrett-Reis B, White RD, Ahmad KA, Oliver J, Baggs G, Williams L, Adamkin D. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018 Nov;202:31-37.e2. doi: 10.1016/j.jpeds.2018.07.005. Epub 2018 Sep 5.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Bridget Barrett-Reis, PhD, RD study chair
Abbott Nutrition
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk Fortifier A and Human Milk Fortifier B in people with Infant Growth, run by Abbott Nutrition at 18 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Gain (time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307760, which also lists 2 linked publications.
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 11 May 2017.