BreastfeedingELFNCT00952328
Effect of Early Limited Formula Use on Breastfeeding Outcomes
A study testing Nutramigen infant formula in people with Breastfeeding, run by University of California, San Francisco at 1 site in United States.
Trial summary
The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. Read more about this study
- Who is it for?
- Ages 24 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Nutramigen infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2013
- 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 24 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants (37 to 42 weeks gestation)
- Infants who have lost 5% of their birth weight at <36 hours of age
Who cannot join
- Infants who have received formula or water
- Mothers who are producing mature milk supply
- Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco Medical Center
San Francisco, California, 94143
About this study
The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.
- Conditions
- Breastfeeding
- Being tested
- Nutramigen infant formula
- Keywords
- breastfeeding outcomes, breastfeeding self-efficacy, infant weight loss
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutramigen infant formulaDietary supplement
Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins.
| Study group | Role | What they receive |
|---|---|---|
| Limited Formula | Experimental | Participants will supplement feedings with early limited formula following nursing Receives: Dietary Supplement: Nutramigen infant formula |
| Control | No intervention | Participants are instructed to continue exclusively breastfeeding; no use of formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is infant receiving exclusively breast milk at 8 days of life?
Measured: 8 days following baseline
Secondary outcomes (1)
Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?
Measured: 1-3 months following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Valerie Flaherman, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952328
- Sponsor's protocol ID
- H49316-34032-01
- Other IDs
- 5 K12 HD052 163 Development
- Acronym
- ELF
- Status last verified
- Apr 2014
- First submitted
- 29 Jul 2009
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Limited Formula Use on Breastfeeding Outcomes
- ClinicalTrials.gov ID
- NCT00952328
- Acronym / sponsor ID
- ELF / H49316-34032-01
- Conditions
- Breastfeeding
- Keywords
- breastfeeding outcomes, breastfeeding self-efficacy, infant weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Aug 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Aug 2009 (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 aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited Formula | Experimental | Dietary Supplement: Nutramigen infant formulaParticipants will supplement feedings with early limited formula following nursing |
| Control | No intervention | –Participants are instructed to continue exclusively breastfeeding; no use of formula |
Who may qualify
- Ages
- 24 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy term infants (37 to 42 weeks gestation)
- Infants who have lost 5% of their birth weight at <36 hours of age
Key exclusion criteria (3 listed)
- Infants who have received formula or water
- Mothers who are producing mature milk supply
- Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending
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 |
|---|---|---|
| Nutramigen infant formulaInvestigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins. | Dietary supplement | Limited Formula |
Primary outcome
Is infant receiving exclusively breast milk at 8 days of life?
Time frame: 8 days following baseline
1 secondary outcome
Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?
Time frame: 1-3 months following baseline
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 Apr 2014.
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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.
Valerie Flaherman, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutramigen infant formula in people with Breastfeeding, run by University of California, San Francisco 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 Apr 2014. 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?
Is infant receiving exclusively breast milk at 8 days of life? (time frame: 8 days following baseline). 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 Apr 2014.