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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02313181
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : May 3, 2018
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

Study Description
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Brief 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. 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 or disease Intervention/treatment Phase
Breastfeeding Other: Early Limited Formula Other: Standard Care Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. Formula use [ Time Frame: 6 months ]
    The investigators will follow babies for 6 months to determine the volume of formula used.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Hours 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
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Valerie Flaherman, MD, MPH University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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