Early Limited Formula for Treating Lactation Concerns

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Other: Standard Care; Other: Early Limited Formula

• Registration Number: NCT02313181
• Lead Sponsor: University of California, San Francisco

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 available

Study Timeline

• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Study Start: 2015-01-07
• Primary Completion: 2017-03-30
• Study Completion: 2017-10-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Continue exclusive breastfeeding unless otherwise instructed by a health care provider
Early Limited Formula	Early Limited Formula	10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production

Primary Outcome Measures

Name	Time	Method
Length of breastfeeding duration	12 months	The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding

Secondary Outcome Measures

Name	Time	Method
State Trait Anxiety Inventory	1 month	The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory.
Health care utilization	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	6 months	The investigators will follow babies for 6 months to determine the volume of formula used.

Trial Locations

Locations (2)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States