Effect of Early Limited Formula Use on Breastfeeding Outcomes (ELF)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breastfeeding |
Dietary Supplement: Nutramigen infant formula |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Early Limited Formula Use on Breastfeeding Outcomes |
- Is infant receiving exclusively breast milk at 8 days of life? [ Time Frame: 8 days following baseline ] [ Designated as safety issue: No ]
- Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months? [ Time Frame: 1-3 months following baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Limited Formula
Participants will supplement feedings with early limited formula following nursing
|
Dietary Supplement: Nutramigen infant formula
Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins.
|
|
No Intervention: Control
Participants are instructed to continue exclusively breastfeeding; no use of formula
|
Eligibility| Ages Eligible for Study: | up to 48 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 CBC and blood tests pending
Contacts and Locations| United States, California | |
| University of California, San Francisco Medical Center | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Valerie Flaherman, MD, MPH | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00952328 History of Changes |
| Other Study ID Numbers: | H49316-34032-01, 5 K12 HD052 163 Development |
| Study First Received: | July 29, 2009 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
breastfeeding outcomes breastfeeding self-efficacy infant weight loss |
ClinicalTrials.gov processed this record on May 16, 2013