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Completed

NCT Number: NCT02313181

Early Limited Formula for Treating Lactation Concerns

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco Medical Center, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Early Limited Formula

Other

10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production

Other names: ELF

Standard care

Other

Continue exclusive breastfeeding unless otherwise directed by a health care provider

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau
  • Milton S. Hershey Medical Center

Registry information

Acronym: ELF-TLC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2014
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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