Early Limited Formula for Treating Lactation Concerns

Study Overview
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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.

Official Title
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Early Limited Formula for Treating Lactation Concerns

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: Early Limited Formula
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Limited Formula<br>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<br>* 10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production<br>* Other names: ELF;|
| Other: Standard Care<br>Continue exclusive breastfeeding unless otherwise instructed by a health care provider | Other: Standard Care<br>* Continue exclusive breastfeeding unless otherwise directed by a health care provider<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of breastfeeding duration | The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Trait Anxiety Inventory | The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory. | 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. | 1 month | 
| Formula use | The investigators will follow babies for 6 months to determine the volume of formula used. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breastfeeding, lactation, newborn