A Post Breastfeeding Follow-Up Study

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

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this clinical study which is to evaluate the benefits of lactation support intervention, in conjunction with maternal nutritional supplementation during the last trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast feeding practices (primary objective), and 2) cognitive development in children within 28 months 16 days - 32 months 30 days (secondary objective).

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Detailed Description

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This is an observational study involving mothers and their child at 30 months old as a follow up to the breastfeeding intervention study that they have participated in and completed during the period from the last trimester to 12 weeks postpartum.

The assessors will be blinded to subject's treatment group assignment from the intervention phase.

There are no products given to any subject.

The primary variable is duration of any breastfeeding from birth.

Conditions

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Breast Feeding

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Mother and child pair was enrolled in and completed the breastfeeding intervention (AL08) study.
* Age of child is within the allowable window (28 months 16 days - 32 months 30 days).
* Subject's parent/Legally Acceptable Representative (LAR) is willing and able to follow study procedures.
* Subject's parent/LAR has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.