A Post Breastfeeding Follow-Up Study

Breast Feeding Clinical Trial

Official title:

A Post-Breastfeeding Intervention Observational Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913638
• Other study ID #: AL08X
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: February 10, 2017
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Months to 32 Months

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding

Locations

Country	Name	City	State
Vietnam	Binh Luc District Health Center	Ha Nam
Vietnam	An Lao District Health Center	Hai Phong
Vietnam	Yen Mo District Health Center	Ninh Binh
Vietnam	Phu Binh District Health Center	Thai Nguyen

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cognitive outcomes	Bayley Scales (BSID-III) of Infant and Toddler Development	32 months
Secondary	Language/Communication outcomes	Age & Stages Questionnaire (ASQ-3)	32 months