Infant, Very Low Birth WeightNCT00601081
Human Milk Fortifier and Cytokine Profile
An observational study of Infant, Very Low Birth Weight, run by Christiana Care Health Services at 1 site in United States.
Trial summary
This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant, Very Low Birth Weight
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jun 2008
- Phase
- Observational
- 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 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants hospitalized in the newborn intensive care unit.
Who may be able to join
- Infants born weighing less than 1500 grams
- exclusive breast milk feedings with intention to fortify with human milk fortifier
Who cannot join
- positive blood culture
- history of necrotizing enterocolitis
- significant lung disease at the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier
This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.
Read the detailed description
In very low birth weight (VLBW) infants and preterm infants human milk fortifier (HMF) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. It is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. Cytokines, marker of immune function, can be found in blood, stool, and breast milk. This study involves collection of blood and stool samples to monitor cytokines. The purpose of this study is to understand whether human milk fortifier alters infants' cytokines.
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- Very low birth weight infants, HMF, immune system function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine profile pre and post initiation of HMF
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJun 2008
- Study completionJun 2008
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert G. Locke, DO, Principal investigator, Christiana HospitalChristopher T. Hsu, MD, Principal investigator, Christiana Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601081
- Sponsor's protocol ID
- 27127
- Status last verified
- May 2017
- First submitted
- 15 Jan 2008
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier
- ClinicalTrials.gov ID
- NCT00601081
- Acronym / sponsor ID
- 27127
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- Very low birth weight infants, HMF, immune system function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Jan 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 is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.
Detailed description
In very low birth weight (VLBW) infants and preterm infants human milk fortifier (HMF) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. It is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. Cytokines, marker of immune function, can be found in blood, stool, and breast milk. This study involves collection of blood and stool samples to monitor cytokines. The purpose of this study is to understand whether human milk fortifier alters infants' cytokines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Very low birth weight and preterm infants who will likely receive fortification of breast milk with HMF |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants hospitalized in the newborn intensive care unit.
Key inclusion criteria (2 listed)
- Infants born weighing less than 1500 grams
- exclusive breast milk feedings with intention to fortify with human milk fortifier
Key exclusion criteria (3 listed)
- positive blood culture
- history of necrotizing enterocolitis
- significant lung disease at the start of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cytokine profile pre and post initiation of HMF
Time frame: up to 14 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 10 May 2017.
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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.
Robert G. Locke, DO principal investigator
Christiana Hospital
Christopher T. Hsu, MD principal investigator
Christiana Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Very Low Birth Weight, run by Christiana Care Health Services 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 2 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 10 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 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?
Cytokine profile pre and post initiation of HMF (time frame: up to 14 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 10 May 2017.