Early Limited Formula for Treating Lactation Concerns

University of California, San Francisco328 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

328

Conditions

Breastfeeding

Interventions

Early Limited FormulaOTHER

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

Standard CareOTHER

Continue exclusive breastfeeding unless otherwise directed by a health care provider

Eligibility

Sex: ALLMin age: 18 HoursMax age: 72 HoursHealthy volunteers:

Medical Language ↔ Plain English

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 -

Locations (2)

University of California, San Francisco Medical Center

San Francisco, California, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Length of breastfeeding duration

The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding

Time frame: 12 months

Secondary Outcomes

State Trait Anxiety Inventory

The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory.

Time frame: 1 month

Health care utilization

The investigators will follow babies for 1 month to determine how often they were seen by an outpatient provider, inpatient provider or emergency provider.

Time frame: 1 month

Formula use

The investigators will follow babies for 6 months to determine the volume of formula used.

Time frame: 6 months

Data from ClinicalTrials.gov

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