Clinical trial NCT02313181: Early Limited Formula for Treating Lactation Concerns
Official title: Early Limited Formula for Treating Lactation Concerns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: breastfeeding
lactation
newborn
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Milton S. Hershey Medical Center
name: HRSA/Maternal and Child Health Bureau
First posted: 2014-12-09
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: Length of breastfeeding duration
timeFrame: 12 months
Secondary outcomes:
measure: State Trait Anxiety Inventory
timeFrame: 1 month
measure: Health care utilization
timeFrame: 1 month
measure: Formula use
timeFrame: 6 months
Other outcomes:
measure: Edinburg Postnatal Depression Scale
timeFrame: 1 month
measure: Breastfeeding Self-Efficacy Scale
timeFrame: 1 month
measure: Satisfaction with Quality of Care
timeFrame: 1 month
measure: Milk supply concern
timeFrame: 1 month
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: University of California, San Francisco
name: Valerie Flaherman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.