Status:
COMPLETED
Early Limited Formula for Treating Lactation Concerns
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Milton S. Hershey Medical Center
HRSA/Maternal and Child Health Bureau
Conditions:
Breastfeeding
Eligibility:
All Genders
18-72 years
Phase:
NA
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 strat...
Eligibility Criteria
Inclusion
- Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
- Exclusively breastfeeding (has not received any feedings other than breast milk)
- Infant is 18-72 hours old
- Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
- English-speaking mother
Exclusion
- Mothers or infants for whom breastfeeding is not recommended by the clinical team
- Mothers who have already begun to produce mature breast milk
- Any formula or water feeding prior to enrollment
- Infants who have already lost ≥10% of their birth weight
- Family with no active telephone number (home or cellular)
- Plan for infant adoption or foster care
- Mothers \<18 years of age
- Infant receiving scoring for Narcotic Abstinence Syndrome -
Key Trial Info
Start Date :
January 7 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT02313181
Start Date
January 7 2015
End Date
October 1 2017
Last Update
May 3 2018
Active Locations (2)
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1
University of California, San Francisco Medical Center
San Francisco, California, United States, 94122
2
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033