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Completed

NCT Number: NCT02913638

A Post Breastfeeding Follow-Up Study

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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Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Age range

28 month–32 month

Sex eligibility

All sexes

Study type

Observational

Primary location

An Lao District Health Center, Haiphong, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Child has a diagnosis of developmental disorders e.g. cerebral palsy that require medical intervention prior to enrollment in this study.

Treatment and study plan

Primary outcomes

  1. Duration of any breastfeeding from birth

    Time frame: 32 months

    The primary variable, which is the duration of any breastfeeding from birth, will be assessed in all mothers recruited for this study. A questionnaire will be used to capture information on the age of the child (in months/weeks) in which the mother stopped breastfeeding. This information will be used to derive any breastfeeding duration from birth onwards.

Secondary outcomes

  1. Cognitive outcomes

    Time frame: 32 months

    Bayley Scales (BSID-III) of Infant and Toddler Development

  2. Language/Communication outcomes

    Time frame: 32 months

    Age & Stages Questionnaire (ASQ-3)

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

A Post-Breastfeeding Intervention Observational Follow-Up Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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