Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 5, 2014
First Posted Date  ICMJE December 9, 2014
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE January 7, 2015
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
Length of breastfeeding duration [ Time Frame: 12 months ]
The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
Breastfeeding duration [ Time Frame: 12 months ]
We will follow babies for 12 months to determine how long they continued breastfeeding
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • Maternal anxiety [ Time Frame: 1 month ]
    We will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory.
  • Outpatient utilization [ Time Frame: 1 month ]
    We 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 ]
    We will follow babies for 6 months to determine the volume of formula used.
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2014)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: December 5, 2014)
  • Maternal depression [ Time Frame: 1 month ]
    We will follow mothers for 1 month to determine their score on the Edinburg Postnatal Depression Scale
  • Breastfeeding Self-Efficacy [ Time Frame: 1 month ]
    We 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 ]
    We 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 ]
    We will follow mothers for 1 month to determine their score on the Infant Satisfaction and Satiety Subscale
 
Descriptive Information
Brief Title  ICMJE Early Limited Formula for Treating Lactation Concerns
Official Title  ICMJE Early Limited Formula for Treating Lactation Concerns
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Breastfeeding
Intervention  ICMJE
  • 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
  • Other: Standard Care
    Continue exclusive breastfeeding unless otherwise directed by a health care provider
Study Arms  ICMJE
  • 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
    Intervention: Other: Early Limited Formula
  • Standard Care
    Continue exclusive breastfeeding unless otherwise instructed by a health care provider
    Intervention: Other: Standard Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2014)
328
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2017
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 72 Hours   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02313181
Other Study ID Numbers  ICMJE R40-MC26810
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valerie Flaherman, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Milton S. Hershey Medical Center
  • HRSA/Maternal and Child Health Bureau
Investigators  ICMJE
Principal Investigator: Valerie Flaherman, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP