A Post-Breastfeeding Intervention Observational Follow-Up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 196
- Locations
- 4
- Primary Endpoint
- Duration of any breastfeeding from birth
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 28 Months to 32 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Duration of any breastfeeding from birth
Time Frame: 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 Outcomes
- Cognitive outcomes(32 months)
- Language/Communication outcomes(32 months)