Effect of Early Limited Formula Use on Breastfeeding Outcomes (ELF)

University of California San Francisco (UCSF)

Status

Completed

Conditions

Breastfeeding

Treatments

Dietary Supplement: Nutramigen infant formula

Study type

Interventional

Funder types

Other

Identifiers

NCT00952328

H49316-34032-01

5 K12 HD052 163 Development

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

24 to 48 hours old

Volunteers

Accepts Healthy Volunteers

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