Very Low Birth Weight InfantsPhase 1NCT02731092
Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
A Phase 1 study testing Lactoferrin in people with Very Low Birth Weight Infants, run by University of Virginia at 2 sites in United States.
Trial summary
To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Very Low Birth Weight Infants
- What is being tested?
- Lactoferrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Mar 2017
- Phase
- Phase 1
- 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 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- < 15 days of age and receiving enteral feedings
- < 1500 grams birth weight
- <37 weeks gestation
Who cannot join
- Congenital bowel obstruction ( esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
- Known necrotizing enterocolitis or bowel perforation
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Virginia Neonatal Intensive Care Unit
Charlottesville, Virginia, 22908
David Kaufman, MD, 434-924-9114, Dak4r@virginia.edu
David Kaufman, MD
- Recruiting
University of Virginia HealthSystem
Charlottesville, Virginia, 22932
David A Kaufman, MD, 434-924-5428, dak4r@virginia.edu
About this study
To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
Read the detailed description
Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
- Lactoferrin related adverse events and serious adverse events
- Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
- Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
- Examine lactoferrin levels in saliva, urine, plasma and stool
- Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
- Conditions
- Very Low Birth Weight Infants
- Being tested
- Lactoferrin
- Keywords
- lactoferrin, very low birth weight infants, preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDietary supplement
Also called Bioferrin® 2000
Bovine Lactoferrin 100 mg/ml dissolved in sterile water
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin 100 mg/kg | Experimental | 100 mg/kg enteral administration daily for 30 days Receives: Dietary Supplement: Lactoferrin |
| Lactoferrin 200 mg/kg | Experimental | 200 mg/kg enteral administration daily for 30 days Receives: Dietary Supplement: Lactoferrin |
| Lactoferrin 300 mg/kg | Experimental | 300 mg/kg enteral administration daily for 30 days Receives: Dietary Supplement: Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definitely related study solution serious adverse event
Measured: 30 days while receiving study solution
Secondary outcomes (2)
Number of infants reaching 120 ml/kg of enteral feeds
Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution
Measured: 30 days while receiving study solution
Number of days not receiving any feedings after lactoferrin administration
Number of days not receiving any feedings after lactoferrin administration begun
Measured: 30 days while receiving study solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, David A Kaufman, University of Virginia
- Investigators
- David A Kaufman, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731092
- Sponsor's protocol ID
- IRB-HSR 18130
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: At UVA and MTA with outside institutions
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02731092
- Acronym / sponsor ID
- IRB-HSR 18130
- Conditions
- Very Low Birth Weight Infants
- Keywords
- lactoferrin, very low birth weight infants, preterm infants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Apr 2016 (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 the safety and tolerability of three different lactoferrin doses in preterm infants
Detailed description
Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
- Lactoferrin related adverse events and serious adverse events
- Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
- Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
- Examine lactoferrin levels in saliva, urine, plasma and stool
- Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin 100 mg/kg | Experimental | Dietary Supplement: Lactoferrin100 mg/kg enteral administration daily for 30 days |
| Lactoferrin 200 mg/kg | Experimental | Dietary Supplement: Lactoferrin200 mg/kg enteral administration daily for 30 days |
| Lactoferrin 300 mg/kg | Experimental | Dietary Supplement: Lactoferrin300 mg/kg enteral administration daily for 30 days |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- < 15 days of age and receiving enteral feedings
- < 1500 grams birth weight
- <37 weeks gestation
Key exclusion criteria (2 listed)
- Congenital bowel obstruction ( esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
- Known necrotizing enterocolitis or bowel perforation
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 |
|---|---|---|
| LactoferrinAlso: Bioferrin® 2000Bovine Lactoferrin 100 mg/ml dissolved in sterile water | Dietary supplement | Lactoferrin 100 mg/kg, Lactoferrin 200 mg/kg, Lactoferrin 300 mg/kg |
Primary outcome
Definitely related study solution serious adverse event
Time frame: 30 days while receiving study solution
2 secondary outcomes
Number of infants reaching 120 ml/kg of enteral feeds
Time frame: 30 days while receiving study solution
Number of days not receiving any feedings after lactoferrin administration
Time frame: 30 days while receiving study solution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Individual participant dataSharing planned: Yes. At UVA and MTA with outside institutions
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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.
David A Kaufman, MD principal investigator
University of Virginia School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactoferrin in people with Very Low Birth Weight Infants, run by University of Virginia at 2 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 2 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: status not confirmed, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David A Kaufman, MD (4349245428, dak4r@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definitely related study solution serious adverse event (time frame: 30 days while receiving study solution). 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 19 Apr 2016.