A Post Breastfeeding Follow-Up Study

Completed

• Conditions: Breast Feeding

• Registration Number: NCT02913638
• Lead Sponsor: Abbott Nutrition

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of any breastfeeding from birth	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 Outcome Measures

Name	Time	Method
Cognitive outcomes	32 months	Bayley Scales (BSID-III) of Infant and Toddler Development
Language/Communication outcomes	32 months	Age \& Stages Questionnaire (ASQ-3)

Trial Locations

Locations (4)

An Lao District Health Center; 🇻🇳 Hai Phong, Vietnam

Yen Mo District Health Center; 🇻🇳 Ninh Binh, Vietnam

Binh Luc District Health Center; 🇻🇳 Ha Nam, Vietnam

Phu Binh District Health Center; 🇻🇳 Thai Nguyen, Vietnam