Premature InfantsNCT00681018
Feeding Study in Premature Infants
A study testing Liquid human milk fortifier and Powder human milk fortifier in people with Premature Infants, run by Mead Johnson Nutrition at 14 sites in United States.
Trial summary
To evaluate weight gain of preterm infants fed fortified human milk. Read more about this study
- Who is it for?
- Ages Up to 40 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Infants
- What is being tested?
- Liquid human milk fortifier and Powder human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2008to Aug 2010
- 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 Up to 40 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- premature infant
- birth weight less than/equal to 1250 g
- exclusively breast fed
Who cannot join
- metabolic or chronic disease
- major surgery
- ventilator dependent
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Fairfax Hospital
Falls Church, Virginia, 22046
Pitt County Memorial Hospital
Greenville, North Carolina, 27834
University of Florida
Jacksonville, Florida, 32207
University of Florida
Jacksonville, Florida, 32209
Queen's Hospital
Jamaica, New York, 11432
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital
Omaha, Nebraska, 68114
Advocate Lutheran General Children's Hospital
Park Ridge, Illinois, 60068
Plantation General Hospital
Plantation, Florida, 33317
Virginia Commonwealth University
Richmond, Virginia, 23298
All Children's Hospital
St. Petersburg, Florida, 33701
SEAHEC
Wilmington, North Carolina, 28402
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
To evaluate weight gain of preterm infants fed fortified human milk.
- Conditions
- Premature Infants
- Being tested
- Liquid human milk fortifier, Powder human milk fortifier
- Keywords
- premature, infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid human milk fortifierOther
Also called No other names -- experimental product
Liquid human milk fortifier added to human milk
Powder human milk fortifierOther
Also called Enfamil Human Milk Fortifier
Powder human milk fortifier added to human milk
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Liquid human milk fortifier Receives: Other: Liquid human milk fortifier |
| 2 | Active comparator | Powder human milk fortifier Receives: Other: Powder human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 28 days
Secondary outcomes (1)
Feeding tolerance
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carol Lynn Berseth, MD, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681018
- Sponsor's protocol ID
- 3379-1
- Status last verified
- Aug 2010
- First submitted
- 15 May 2008
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Study in Premature Infants
- ClinicalTrials.gov ID
- NCT00681018
- Acronym / sponsor ID
- 3379-1
- Conditions
- Premature Infants
- Keywords
- premature, infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 May 2008 (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.
To evaluate weight gain of preterm infants fed fortified human milk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Liquid human milk fortifierLiquid human milk fortifier |
| 2 | Active comparator | Other: Powder human milk fortifierPowder human milk fortifier |
Who may qualify
- Ages
- Up to 40 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- premature infant
- birth weight less than/equal to 1250 g
- exclusively breast fed
Key exclusion criteria (3 listed)
- metabolic or chronic disease
- major surgery
- ventilator dependent
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 |
|---|---|---|
| Liquid human milk fortifierAlso: No other names -- experimental productLiquid human milk fortifier added to human milk | Other | 1 |
| Powder human milk fortifierAlso: Enfamil Human Milk FortifierPowder human milk fortifier added to human milk | Other | 2 |
Primary outcome
Weight gain
Time frame: 28 days
1 secondary outcome
Feeding tolerance
Time frame: 28 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 31 Aug 2010.
Related trials for Premature Infants
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Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
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The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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.
Carol Lynn Berseth, MD study director
Mead Johnson 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 Liquid human milk fortifier and Powder human milk fortifier in people with Premature Infants, run by Mead Johnson 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 3 inclusion and 3 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 31 Aug 2010. 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?
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: 28 days). 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 31 Aug 2010.