A Post Breastfeeding Follow-Up Study

NCT02913638 | Completed

• 1 other identifier: AL08X
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 4

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).

Conditions

Breast Feeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cognitive outcomes

  32 months

• Language/Communication outcomes

  32 months

Eligibility Criteria

• Age: 28 Months - 32 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (4)

An Lao District Health Center

Haiphong, Vietnam

Location

Binh Luc District Health Center

Hà Nam, Vietnam

Location

Yen Mo District Health Center

Ninh Bình, Vietnam

Location

Phu Binh District Health Center

Thái Nguyên, Vietnam

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Dieu Huynh, M.D.

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (4)