Effect of Early Limited Formula Use on Breastfeeding Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Early Limited Formula Use on Breastfeeding Outcomes

Conditions
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Breastfeeding

Intervention / Treatment
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* Dietary Supplement: Nutramigen infant formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limited Formula<br>Participants will supplement feedings with early limited formula following nursing | Dietary Supplement: Nutramigen infant formula<br>* 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.<br>|
| No Intervention: Control<br>Participants are instructed to continue exclusively breastfeeding; no use of formula | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is infant receiving exclusively breast milk at 8 days of life? |  | 8 days following baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months? |  | 1-3 months following baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breastfeeding outcomes, breastfeeding self-efficacy, infant weight loss