BreastfeedingELF-TLCNCT02313181
Early Limited Formula for Treating Lactation Concerns
A study testing Early Limited Formula in people with Breastfeeding, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. Read more about this study
- Who is it for?
- Ages 18 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Early Limited Formula
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2015to 1 Oct 2017
- 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 18 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
- Exclusively breastfeeding (has not received any feedings other than breast milk)
- Infant is 18-72 hours old
- Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
- English-speaking mother
Who cannot join
- Mothers or infants for whom breastfeeding is not recommended by the clinical team
- Mothers who have already begun to produce mature breast milk
- Any formula or water feeding prior to enrollment
- Infants who have already lost ≥10% of their birth weight
- Family with no active telephone number (home or cellular)
- Plan for infant adoption or foster care
- Mothers <18 years of age
- Infant receiving scoring for Narcotic Abstinence Syndrome -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
University of California, San Francisco Medical Center
San Francisco, California, 94122
About this study
This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.
- Conditions
- Breastfeeding
- Being tested
- Early Limited Formula, Standard Care
- Keywords
- breastfeeding, lactation, newborn
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Limited FormulaOther
Also called ELF
10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
Standard CareOther
Continue exclusive breastfeeding unless otherwise directed by a health care provider
| Study group | Role | What they receive |
|---|---|---|
| Early Limited Formula | Experimental | 10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production Receives: Other: Early Limited Formula |
| Standard Care | Other | Continue exclusive breastfeeding unless otherwise instructed by a health care provider Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of breastfeeding duration
The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding
Measured: 12 months
Secondary outcomes (3)
State Trait Anxiety Inventory
The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory.
Measured: 1 month
Health care utilization
The investigators will follow babies for 1 month to determine how often they were seen by an outpatient provider, inpatient provider or emergency provider.
Measured: 1 month
Formula use
The investigators will follow babies for 6 months to determine the volume of formula used.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study start7 Jan 2015
- Primary completion30 Mar 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, HRSA/Maternal and Child Health Bureau
- Responsible party
- Principal investigator, Valerie Flaherman, University of California, San Francisco
- Investigators
- Valerie Flaherman, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313181
- Sponsor's protocol ID
- R40-MC26810
- Acronym
- ELF-TLC
- Status last verified
- May 2018
- First submitted
- 5 Dec 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Flaherman VJ, Cabana MD, McCulloch CE, Paul IM. Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial. JAMA Pediatr. 2019 Aug 1;173(8):729-735. doi: 10.1001/jamapediatrics.2019.1424.
PubMed 31157878Flaherman VJ, Narayan NR, Hartigan-O'Connor D, Cabana MD, McCulloch CE, Paul IM. The Effect of Early Limited Formula on Breastfeeding, Readmission, and Intestinal Microbiota: A Randomized Clinical Trial. J Pediatr. 2018 May;196:84-90.e1. doi: 10.1016/j.jpeds.2017.12.073. Epub 2018 Mar 14.
PubMed 29550235
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Limited Formula for Treating Lactation Concerns
- ClinicalTrials.gov ID
- NCT02313181
- Acronym / sponsor ID
- ELF-TLC / R40-MC26810
- Conditions
- Breastfeeding
- Keywords
- breastfeeding, lactation, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, HRSA/Maternal and Child Health Bureau
- Study start
- 7 Jan 2015 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 9 Dec 2014 (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 randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Limited Formula | Experimental | Other: Early Limited Formula10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production |
| Standard Care | Other | Other: Standard CareContinue exclusive breastfeeding unless otherwise instructed by a health care provider |
Who may qualify
- Ages
- 18 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
- Exclusively breastfeeding (has not received any feedings other than breast milk)
- Infant is 18-72 hours old
- Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
- English-speaking mother
Key exclusion criteria (8 listed)
- Mothers or infants for whom breastfeeding is not recommended by the clinical team
- Mothers who have already begun to produce mature breast milk
- Any formula or water feeding prior to enrollment
- Infants who have already lost ≥10% of their birth weight
- Family with no active telephone number (home or cellular)
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 |
|---|---|---|
| Early Limited FormulaAlso: ELF10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production | Other | Early Limited Formula |
| Standard CareContinue exclusive breastfeeding unless otherwise directed by a health care provider | Other | Standard Care |
Primary outcome
Length of breastfeeding duration
Time frame: 12 months
The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding
3 secondary outcomes
State Trait Anxiety Inventory
Time frame: 1 month
Health care utilization
Time frame: 1 month
Formula use
Time frame: 6 months
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 3 May 2018.
- Derived from this study: PubMed 31157878Flaherman VJ, Cabana MD, McCulloch CE, Paul IM. Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial. JAMA Pediatr. 2019 Aug 1;173(8):729-735. doi: 10.1001/jamapediatrics.2019.1424.
- Derived from this study: PubMed 29550235Flaherman VJ, Narayan NR, Hartigan-O'Connor D, Cabana MD, McCulloch CE, Paul IM. The Effect of Early Limited Formula on Breastfeeding, Readmission, and Intestinal Microbiota: A Randomized Clinical Trial. J Pediatr. 2018 May;196:84-90.e1. doi: 10.1016/j.jpeds.2017.12.073. Epub 2018 Mar 14.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Limited Formula in people with Breastfeeding, run by University of California, San Francisco 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 5 inclusion and 8 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 3 May 2018. 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.
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?
Length of breastfeeding duration (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02313181, which also lists 2 linked publications.
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 3 May 2018.