Effect of Early Limited Formula Use on Breastfeeding Outcomes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00952328

Acronym

ELF

Enrollment

Registered

2009-08-06

Start date

2009-08-31

Completion date

2013-04-30

Last updated

2014-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

breastfeeding outcomes, breastfeeding self-efficacy, infant weight loss

Brief summary

The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.

Interventions

DIETARY_SUPPLEMENTNutramigen infant formula

Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

24 Hours to 48 Hours

Healthy volunteers

Yes

Inclusion criteria

* Healthy term infants (37 to 42 weeks gestation) * Infants who have lost 5% of their birth weight at \<36 hours of age

Exclusion criteria

* Infants who have received formula or water * Mothers who are producing mature milk supply * Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending

Design outcomes

Primary

Measure	Time frame
Is infant receiving exclusively breast milk at 8 days of life?	8 days following baseline

Secondary

Measure	Time frame
Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?	1-3 months following baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026