Effect of Early Limited Formula Use on Breastfeeding Outcomes

Breastfeeding Clinical Trial

— ELF  

Official title:

Effect of Early Limited Formula Use on Breastfeeding Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952328
• Other study ID #: H49316-34032-01
• Secondary ID: 5 K12 HD052 163
• Status: Completed
• Phase: N/A
• First received: July 29, 2009
• Last updated: April 9, 2014
• Start date: August 2009
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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 complete blood count and blood tests pending

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is infant receiving exclusively breast milk at 8 days of life?		8 days following baseline	No
Secondary	Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?		1-3 months following baseline	No