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Early Limited Formula for Treating Lactation Concerns (ELF-TLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
Valerie Flaherman, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02313181
First received: December 5, 2014
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Breastfeeding
Other: Early Limited Formula
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Early Limited Formula for Treating Lactation Concerns

Resource links provided by NLM:


Further study details as provided by Valerie Flaherman, University of California, San Francisco:

Primary Outcome Measures:
  • Length of breastfeeding duration [ Time Frame: 12 months ]
    The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Enrollment: 328
Study Start Date: December 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other: Standard Care
Continue exclusive breastfeeding unless otherwise directed by a health care provider

  Eligibility

Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
  2. Exclusively breastfeeding (has not received any feedings other than breast milk)
  3. Infant is 18-72 hours old
  4. Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
  5. English-speaking mother

Exclusion Criteria:

  1. Mothers or infants for whom breastfeeding is not recommended by the clinical team
  2. Mothers who have already begun to produce mature breast milk
  3. Any formula or water feeding prior to enrollment
  4. Infants who have already lost ≥10% of their birth weight
  5. Family with no active telephone number (home or cellular)
  6. Plan for infant adoption or foster care
  7. Mothers <18 years of age
  8. Infant receiving scoring for Narcotic Abstinence Syndrome -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02313181

Locations
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
Sponsors and Collaborators
University of California, San Francisco
Milton S. Hershey Medical Center
HRSA/Maternal and Child Health Bureau
Investigators
Principal Investigator: Valerie Flaherman, MD, MPH University of California, San Francisco
  More Information

Responsible Party: Valerie Flaherman, Associate Professor of Pediatrics and Epidemiology and Biostatistics, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02313181     History of Changes
Other Study ID Numbers: R40-MC26810
Study First Received: December 5, 2014
Last Updated: February 16, 2017

Keywords provided by Valerie Flaherman, University of California, San Francisco:
breastfeeding
lactation
newborn

ClinicalTrials.gov processed this record on May 25, 2017