Breastfeeding Intervention Study

Study Overview
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Brief Summary
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To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.

Detailed Description
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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.

Official Title
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Breastfeeding Intervention Study

Conditions
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Breast Feeding

Intervention / Treatment
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* Dietary Supplement: Maternal Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mother with singleton pregnancy at 26 to 29 weeks of gestation. Mother is between 20 and 35 years of age. Mother pre-pregnant BMI < 25.0 kg/m2. Mother is first-time mother. Mother is contactable by telephone. Mother is non-smoker. Infant is a singleton from a full term birth with a gestational age of 37-42 weeks. Infant's birth weight was > 2500 g. Infant is judged to be in good health. Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period. Exclusion Criteria: Mother is allergic or intolerant to any ingredient found in the study product. An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development. Mother has gestational diabetes and/or pre-eclampsia. Mother with contraindications to breastfeeding. Gestational weight gain is greater than 14 kg at enrollment. Mother had a breast surgery. Mother and/or newborn infant has major illness that requires intensive care admission. Infant has major congenital anomaly.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Subjects in the control group will continue to take the prenatal supplement primarily consisting of folic acid (400 mcg), elemental iron (60 mg) and will receive breastfeeding advice during prenatal visits. | |
| Experimental: Intervention<br>Lactation support in conjunction with a maternal nutritional supplement S348S0 | Dietary Supplement: Maternal Nutritional Supplement<br>* S348S0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding Rate |  | Week 12 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding Rate |  | Week 4 postpartum | 
| Lactation Assessment | Maternal completed questionnaire with visual analogue scales | Week 4 postpartum | 
| Infant Anthropometrics | Scale weight; Length and head circumference measurement | Week 4 postpartum | 
| Breastfeeding Rate |  | Week 8 postpartum | 
| Lactation Assessment | Maternal completed questionnaire with visual analogue scales | Week 8 postpartum | 
| Lactation Assessment | Maternal completed questionnaire with visual analogue scales | Week 12 postpartum | 
| Infant Anthropometrics | Scale weight; Length and head circumference measurement | Week 8 postpartum | 
| Infant Anthropometrics | Scale weight; Length and head circumference measurement | Week 12 postpartum |