Early Limited Formula for Treating Lactation Concerns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-07

Study Completion Date

2017-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Limited Formula

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

Group Type EXPERIMENTAL

Early Limited Formula

Intervention Type OTHER

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

Standard Care

Continue exclusive breastfeeding unless otherwise instructed by a health care provider

Group Type OTHER

Standard Care

Intervention Type OTHER

Continue exclusive breastfeeding unless otherwise directed by a health care provider

Interventions

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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 Type OTHER

Standard Care

Continue exclusive breastfeeding unless otherwise directed by a health care provider

Intervention Type OTHER

Other Intervention Names

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ELF

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes