Early Limited Formula for Treating Lactation Concerns (ELF-TLC)

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 Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: Early Limited Formula; Other: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94122
      • University of California, San Francisco Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 hours to 3 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburg Postnatal Depression Scale	The investigators will follow mothers for 1 month to determine their score on the Edinburg Postnatal Depression Scale	1 month
Breastfeeding Self-Efficacy Scale	The investigators will follow mothers for 1 month to determine their score on the Breastfeeding Self-Efficacy Scale	1 month
Satisfaction with Quality of Care	The investigators will follow mothers for 1 month to determine their score on the Satisfaction with Health Care Following Childbirth Scale	1 month
Milk supply concern	The investigators will follow mothers for 1 month to determine their score on the Infant Satisfaction and Satiety Subscale	1 month

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Milton S. Hershey Medical Center; HRSA/Maternal and Child Health Bureau

Publications and helpful links

General Publications

• Flaherman VJ, Cabana MD, McCulloch CE, Paul IM. Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial. JAMA Pediatr. 2019 Aug 1;173(8):729-735. doi: 10.1001/jamapediatrics.2019.1424. Erratum In: JAMA Pediatr. 2019 Aug 1;173(8):801.
• Flaherman VJ, Narayan NR, Hartigan-O'Connor D, Cabana MD, McCulloch CE, Paul IM. The Effect of Early Limited Formula on Breastfeeding, Readmission, and Intestinal Microbiota: A Randomized Clinical Trial. J Pediatr. 2018 May;196:84-90.e1. doi: 10.1016/j.jpeds.2017.12.073. Epub 2018 Mar 14.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2015
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: breastfeeding; lactation; newborn
• Other Study ID Numbers: R40-MC26810