A Post Breastfeeding Follow-Up Study

A Post-Breastfeeding Intervention Observational 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).

Study Overview

• Status: Completed
• Conditions: Breast Feeding

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 Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Vietnam
  • Ha Nam, Vietnam
    • Binh Luc District Health Center
  • Hai Phong, Vietnam
    • An Lao District Health Center
  • Ninh Binh, Vietnam
    • Yen Mo District Health Center
  • Thai Nguyen, Vietnam
    • Phu Binh District Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study involves 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of any breastfeeding from birth	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.	32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive outcomes	Bayley Scales (BSID-III) of Infant and Toddler Development	32 months
Language/Communication outcomes	Age & Stages Questionnaire (ASQ-3)	32 months

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Dieu Huynh, M.D., Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AL08X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO