Early Limited Formula for Treating Lactation Concerns (ELF-TLC)
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ClinicalTrials.gov Identifier: NCT02313181 |
Recruitment Status :
Completed
First Posted : December 9, 2014
Last Update Posted : May 3, 2018
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Condition or disease | Intervention/treatment | Phase |
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Breastfeeding | Other: Early Limited Formula Other: Standard Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 328 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Early Limited Formula for Treating Lactation Concerns |
Actual Study Start Date : | January 7, 2015 |
Actual Primary Completion Date : | March 30, 2017 |
Actual Study Completion Date : | October 1, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Early Limited Formula
10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
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Other: Early Limited Formula
10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
Other Name: ELF |
Standard Care
Continue exclusive breastfeeding unless otherwise instructed by a health care provider
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Other: Standard Care
Continue exclusive breastfeeding unless otherwise directed by a health care provider |
- Length of breastfeeding duration [ Time Frame: 12 months ]The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding
- State Trait Anxiety Inventory [ Time Frame: 1 month ]The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory.
- Health care utilization [ Time Frame: 1 month ]The investigators will follow babies for 1 month to determine how often they were seen by an outpatient provider, inpatient provider or emergency provider.
- Formula use [ Time Frame: 6 months ]The investigators will follow babies for 6 months to determine the volume of formula used.
- Edinburg Postnatal Depression Scale [ Time Frame: 1 month ]The investigators will follow mothers for 1 month to determine their score on the Edinburg Postnatal Depression Scale
- Breastfeeding Self-Efficacy Scale [ Time Frame: 1 month ]The investigators will follow mothers for 1 month to determine their score on the Breastfeeding Self-Efficacy Scale
- Satisfaction with Quality of Care [ Time Frame: 1 month ]The investigators will follow mothers for 1 month to determine their score on the Satisfaction with Health Care Following Childbirth Scale
- Milk supply concern [ Time Frame: 1 month ]The investigators will follow mothers for 1 month to determine their score on the Infant Satisfaction and Satiety Subscale

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Ages Eligible for Study: | 18 Hours to 72 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313181
United States, California | |
University of California, San Francisco Medical Center | |
San Francisco, California, United States, 94122 | |
United States, Pennsylvania | |
Penn State Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Valerie Flaherman, MD, MPH | University of California, San Francisco |
Responsible Party: | Valerie Flaherman, Associate Professor of Pediatrics and Epidemiology and Biostatistics, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02313181 |
Other Study ID Numbers: |
R40-MC26810 |
First Posted: | December 9, 2014 Key Record Dates |
Last Update Posted: | May 3, 2018 |
Last Verified: | May 2018 |
breastfeeding lactation newborn |