Early Limited Formula for Treating Lactation Concerns

Status:	Completed
Conditions:	Healthy Studies
Therapuetic Areas:	Other
Healthy:	No
Age Range:	Any
Updated:	5/5/2018
Start Date:	January 7, 2015
End Date:	October 1, 2017

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.

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 -

We found this trial at

sites

University of California, San Francisco Medical Center

505 Parnassus Ave
San Francisco, California 94143

(415) 476-1000