Breast Feeding
Conditions
Brief summary
To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.
Detailed description
This study aims to evaluate the benefits of a lactation support intervention model combining a maternal nutritional supplementation starting at 8 weeks before delivery to 12 weeks postpartum and a lactation support intervention consisting of 1 prenatal and 3 postnatal sessions on exclusive breastfeeding rate.
Interventions
DIETARY_SUPPLEMENTMaternal Nutritional Supplement
S348S0
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Mother with singleton pregnancy at 26 to 29 weeks of gestation. 2. Mother is between 20 and 35 years of age. 3. Mother pre-pregnant BMI \< 25.0 kg/m2. 4. Mother is first-time mother. 5. Mother is contactable by telephone. 6. Mother is non-smoker. 7. Infant is a singleton from a full term birth with a gestational age of 37-42 weeks. 8. Infant's birth weight was \> 2500 g. 9. Infant is judged to be in good health. 10. Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period.
Exclusion criteria
1. Mother is allergic or intolerant to any ingredient found in the study product. 2. An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development. 3. Mother has gestational diabetes and/or pre-eclampsia. 4. Mother with contraindications to breastfeeding. 5. Gestational weight gain is greater than 14 kg at enrollment. 6. Mother had a breast surgery. 7. Mother and/or newborn infant has major illness that requires intensive care admission. 8. Infant has major congenital anomaly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breastfeeding Rate | Week 12 postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Rate | Week 4 postpartum | — |
| Lactation Assessment | Week 4 postpartum | Maternal completed questionnaire with visual analogue scales |
| Infant Anthropometrics | Week 4 postpartum | Scale weight; Length and head circumference measurement |
Countries
Vietnam
Outcome results
None listed