Breastfeeding
Conditions
Keywords
breastfeeding, lactation, newborn
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.
Interventions
OTHEREarly Limited Formula
10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
OTHERStandard Care
Continue exclusive breastfeeding unless otherwise directed by a health care provider
Sponsors
Milton S. Hershey Medical Center
HRSA/Maternal and Child Health Bureau
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Hours to 72 Hours
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of breastfeeding duration | 12 months | The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health care utilization | 1 month | The investigators will follow babies for 1 month to determine how often they were seen by an outpatient provider, inpatient provider or emergency provider. |
| Formula use | 6 months | The investigators will follow babies for 6 months to determine the volume of formula used. |
| State Trait Anxiety Inventory | 1 month | The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Self-Efficacy Scale | 1 month | The investigators will follow mothers for 1 month to determine their score on the Breastfeeding Self-Efficacy Scale |
| Satisfaction with Quality of Care | 1 month | The investigators will follow mothers for 1 month to determine their score on the Satisfaction with Health Care Following Childbirth Scale |
| Milk supply concern | 1 month | The investigators will follow mothers for 1 month to determine their score on the Infant Satisfaction and Satiety Subscale |
| Edinburg Postnatal Depression Scale | 1 month | The investigators will follow mothers for 1 month to determine their score on the Edinburg Postnatal Depression Scale |
Countries
United States
Outcome results
None listed