Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913638
Other study ID # AL08X
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04487418 - Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Enrolling by invitation NCT02687685 - Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH) N/A
Completed NCT03033459 - Prenatal Lactation-Focused Motivational Interviewing N/A
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Not yet recruiting NCT05846828 - Cognitive Functions in Breastfed Preschool Children
Completed NCT05944471 - The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk N/A
Completed NCT05629403 - Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
Completed NCT04024865 - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting NCT05560750 - Lingual Frenulum in Newborn Infants (LINNE) N/A
Completed NCT03232762 - Effects of Diet on Pregnancy Outcome and Child Obesity N/A
Recruiting NCT02186613 - Telephone Support From Primary Care for Breastfeeding Mothers N/A
Completed NCT01687634 - Home Visiting for Low Income, Pregnant Women N/A
Completed NCT01459991 - The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women N/A
Completed NCT03574766 - Meditation for NICU Moms N/A
Recruiting NCT03945474 - Osteopathic Manipulation in Breastfed Newborns N/A
Recruiting NCT06107933 - Developmental Impacts of Microplastics Exposure in Early Life
Not yet recruiting NCT05059574 - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies N/A
Completed NCT04578925 - Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents N/A
Enrolling by invitation NCT03337893 - Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases N/A