Preterm InfantsPhase 3NCT01373073
Evaluation of a Novel Human Milk Fortifier in Preterm Infants
A Phase 3 study testing Experimental human milk fortifier in people with Preterm Infants, run by Abbott Nutrition at 15 sites in United States.
Trial summary
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier. Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Experimental human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2011to Dec 2012
- Phase
- Phase 3
- 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 Up to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 700-1500g birth weight
- 33 weeks or less gestational age
- Appropriate for gestational age
- Initiate enteral feeds of human milk by 21 days of life
- Mother provided exclusive human milk feeds
- Parents allow both human milk and study human milk fortifier
- Singleton or twin birth
Who cannot join
- Feeding preterm infant formula or non-study human milk fortifier
- Expected at facility less than 15 days
- Congenital anomalies/disease affecting growth and development
- 5 minute APGAR of 4 or less
- Steroid use
- ECMO
Show all 13Show fewer
- Grade III or IV PVH/IVH
- Mechanical ventilator dependency
- Maternal incapacity
- History of major surgery
- Asphyxia
- Confirmed NEC or sepsis
- Use of probiotics
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Alabama
Birmingham, Alabama, 35249-7335
King's County Hospital Center
Brooklyn, New York, 11203
University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cohen Children's Medical Center of New York at North Shore
Manhasset, New York, 11030
Cohen Children's Medical Center of NY at North Shore
New Hyde Park, New York, 11040
OHSU
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84108
UCSD Medical Center
San Diego, California, 92103-8774
Memorial Hospital of Southbend
Southbend, Indiana, 46601
University South Florida
Tampa, Florida, 33606
Toledo Children's Hospital
Toledo, Ohio, 43606
Childrens Hospital Westchester Medical Center
Valhalla, New York, 10595
Wesley Medical Center
Wichita, Kansas, 67214
About this study
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.
- Conditions
- Preterm Infants
- Being tested
- Experimental human milk fortifier, Control human milk fortifier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental human milk fortifierOther
Human milk fortifier to be added to human milk feedings
Control human milk fortifierOther
Control human milk fortifier to be added to human milk
| Study group | Role | What they receive |
|---|---|---|
| Experimental Human Milk Fortifier | Experimental | Experimental human milk fortifier to be added to human milk Receives: Other: Experimental human milk fortifier |
| Control Human Milk Fortifier | Active comparator | Control human milk fortifier to be added to human milk Receives: Other: Control human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 29 days
Secondary outcomes (2)
Anthropometric variables
Length and head circumference
Measured: 29 days
GI tolerance
stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridget Barrett-Reis, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373073
- Sponsor's protocol ID
- AK37
- Status last verified
- Feb 2013
- First submitted
- 8 Jun 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010.
PubMed 26488118
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Human Milk Fortifier in Preterm Infants
- ClinicalTrials.gov ID
- NCT01373073
- Acronym / sponsor ID
- AK37
- Conditions
- Preterm Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jun 2011 (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 an experimental human milk fortifier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Human Milk Fortifier | Experimental | Other: Experimental human milk fortifierExperimental human milk fortifier to be added to human milk |
| Control Human Milk Fortifier | Active comparator | Other: Control human milk fortifierControl human milk fortifier to be added to human milk |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 700-1500g birth weight
- 33 weeks or less gestational age
- Appropriate for gestational age
- Initiate enteral feeds of human milk by 21 days of life
- Mother provided exclusive human milk feeds
Key exclusion criteria (13 listed)
- Feeding preterm infant formula or non-study human milk fortifier
- Expected at facility less than 15 days
- Congenital anomalies/disease affecting growth and development
- 5 minute APGAR of 4 or less
- Steroid use
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 |
|---|---|---|
| Experimental human milk fortifierHuman milk fortifier to be added to human milk feedings | Other | Experimental Human Milk Fortifier |
| Control human milk fortifierControl human milk fortifier to be added to human milk | Other | Control Human Milk Fortifier |
Primary outcome
Weight gain
Time frame: 29 days
2 secondary outcomes
Anthropometric variables
Time frame: 29 days
GI tolerance
Time frame: 29 days
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 20 Feb 2013.
- Derived from this study: PubMed 26488118Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010.
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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 study chair
Abbott Nutrition
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental human milk fortifier in people with Preterm Infants, run by Abbott Nutrition at 15 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 29 days). 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 NCT01373073, which also lists 1 linked publication.
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 20 Feb 2013.