Infant, Very Low Birth WeightNCT00760942
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
A study testing Similac special care 30 and Similac human milk fortifier in people with Infant, Very Low Birth Weight, run by University of Oklahoma at 1 site in United States.
Trial summary
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 10 weeks
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- Similac special care 30 and Similac human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Sep 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 1 day to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants between 500 and 1499 grams of birthweight, receiving mother's milk.
Who cannot join
- Infants with major congenital anomalies and previous history of gastrointestinal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neonatal Intensive Care Unit/Children's Hospital
Oklahoma City, Oklahoma, 73104
About this study
Official title: Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
- Conditions
- Infant, Very Low Birth Weight
- Being tested
- Similac special care 30, Similac human milk fortifier
- Keywords
- Low birth weight, neonates, premature infants, nutrition, human milk fortification, Infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Similac special care 30Dietary supplement
Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.
Similac human milk fortifierDietary supplement
Powdered human milk fortifier.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Liquid human milk fortifier Receives: Dietary Supplement: Similac special care 30 |
| 2 | Active comparator | Powdered human milk fortifier Receives: Dietary Supplement: Similac human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.
Measured: 2 - 6 weeks
Secondary outcomes (1)
Hospital stay and feeding intolerance
Measured: 2-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Willeitner, M.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760942
- Sponsor's protocol ID
- 14132
- Status last verified
- Dec 2013
- First submitted
- 24 Sep 2008
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants
- ClinicalTrials.gov ID
- NCT00760942
- Acronym / sponsor ID
- 14132
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- Low birth weight, neonates, premature infants, nutrition, human milk fortification, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Sep 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.
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Similac special care 30Liquid human milk fortifier |
| 2 | Active comparator | Dietary Supplement: Similac human milk fortifierPowdered human milk fortifier |
Who may qualify
- Ages
- 1 day to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants between 500 and 1499 grams of birthweight, receiving mother's milk.
Key exclusion criteria (1 listed)
- Infants with major congenital anomalies and previous history of gastrointestinal disease.
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 |
|---|---|---|
| Similac special care 30Liquid pre-term formula 30Kcals/oz. used as human milk fortifier. | Dietary supplement | 1 |
| Similac human milk fortifierPowdered human milk fortifier. | Dietary supplement | 2 |
Primary outcome
The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.
Time frame: 2 - 6 weeks
1 secondary outcome
Hospital stay and feeding intolerance
Time frame: 2-6 weeks
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 10 Dec 2013.
Related trials for Infant, Very Low Birth Weight
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Recruiting
Donor Breast Milk 2
Iron Deficiency Anemia
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.
Andrea Willeitner, M.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Similac special care 30 and Similac human milk fortifier in people with Infant, Very Low Birth Weight, run by University of Oklahoma at 1 site 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 1 inclusion and 1 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily. (time frame: 2 - 6 weeks). 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 10 Dec 2013.