A Post Breastfeeding Follow-Up Study

Abbott

Status: Completed

Conditions: Breast Feeding

Study type: Observational

Funder types: Industry

Identifiers

NCT02913638

AL08X

Details and patient eligibility

About

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).

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 28 to 32 months old

Volunteers: Accepts Healthy Volunteers

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.