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OpenTrials
Completed

NCT Number: NCT00952328

Effect of Early Limited Formula Use on Breastfeeding Outcomes

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

24 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutramigen infant formula

Dietary Supplement

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.

Primary outcomes

  1. Is infant receiving exclusively breast milk at 8 days of life?

    Time frame: 8 days following baseline

Secondary outcomes

  1. Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?

    Time frame: 1-3 months following baseline

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Stanford University

Registry information

Acronym: ELF

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Aug 6, 2009
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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