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NCT00952328 · ClinicalTrials.gov registry record · NA

Effect of Early Limited Formula Use on Breastfeeding Outcomes

A NA study of Breastfeeding, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT00952328 is a NA study of Breastfeeding that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 717-participant average among 28 other Breastfeeding trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00952328, a NA study of Breastfeeding, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Nutramigen infant formula

Study Locations (1)

California

  • University of California, San Francisco Medical Center - San Francisco

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2009-08
Est. Completion 2013-04
Phase NA

What the Registry Record Tells You About NCT00952328

The ClinicalTrials.gov registry entry for NCT00952328 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 717-participant average among 28 other Breastfeeding trials with a reported enrollment target (94% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breastfeeding appearing as the primary indexed condition, and to 1 intervention - of which Nutramigen infant formula is the first listed.

NCT00952328 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00952328 about?

NCT00952328 is a clinical study titled "Effect of Early Limited Formula Use on Breastfeeding Outcomes". 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 ...

What is the current status of trial NCT00952328?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2009-08. Estimated completion is 2013-04.

What conditions does trial NCT00952328 study?

This clinical trial studies the following conditions: Breastfeeding.

What interventions are being tested in trial NCT00952328?

The interventions under investigation include: Nutramigen infant formula (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00952328?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00952328 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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