Effect of Early Limited Formula Use on Breastfeeding Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-04-30

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.

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Detailed Description

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Limited Formula

Participants will supplement feedings with early limited formula following nursing

Group Type EXPERIMENTAL

Nutramigen infant formula

Intervention Type DIETARY_SUPPLEMENT

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.

Control

Participants are instructed to continue exclusively breastfeeding; no use of formula

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

24 Hours

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes