Breastfeeding Intervention Study

Abbott

Status: Completed

Conditions: Breast Feeding

Treatments: Dietary Supplement: Maternal Nutritional Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02016586

AL08

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

228 participants in 2 patient groups

Control Group

No Intervention group

Description:

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.

Intervention

Experimental group

Description:

Lactation support in conjunction with a maternal nutritional supplement S348S0

Treatment:

Dietary Supplement: Maternal Nutritional Supplement