NCT02313181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

January 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

December 5, 2014

Last Update Submit

May 1, 2018

Conditions

Breastfeeding

Keywords

breastfeedinglactationnewborn

Outcome Measures

Primary Outcomes (1)

  • Length of breastfeeding duration

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

    12 months

Secondary Outcomes (3)

  • State Trait Anxiety Inventory

    1 month

  • Health care utilization

    1 month

  • Formula use

    6 months

Other Outcomes (4)

  • Edinburg Postnatal Depression Scale

    1 month

  • Breastfeeding Self-Efficacy Scale

    1 month

  • Satisfaction with Quality of Care

    1 month

  • +1 more other outcomes

Study Arms (2)

Early Limited Formula

EXPERIMENTAL

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

Standard Care

OTHER

Continue exclusive breastfeeding unless otherwise instructed by a health care provider

Other: Standard Care

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

Also known as: ELF
Early Limited Formula
Standard CareOTHER

Continue exclusive breastfeeding unless otherwise directed by a health care provider

Standard Care

Eligibility Criteria

Age18 Hours - 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco Medical Center

San Francisco, California, 94122, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

  • 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.

    PMID: 31157878DERIVED

  • 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.

    PMID: 29550235DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Valerie Flaherman, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Epidemiology and Biostatistics

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 9, 2014

Study Start

January 7, 2015

Primary Completion

March 30, 2017

Study Completion

October 1, 2017

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

US(2)