Breastfeeding Intervention Study

Not Applicable

Completed

• Conditions: Breast Feeding
• Interventions: Dietary Supplement: Maternal Nutritional Supplement

• Registration Number: NCT02016586
• Lead Sponsor: Abbott Nutrition

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Maternal Nutritional Supplement	Lactation support in conjunction with a maternal nutritional supplement S348S0

Primary Outcome Measures

Name	Time	Method
Breastfeeding Rate	Week 12 postpartum

Secondary Outcome Measures

Name	Time	Method
Breastfeeding Rate	Week 8 postpartum
Lactation Assessment	Week 12 postpartum	Maternal completed questionnaire with visual analogue scales
Infant Anthropometrics	Week 12 postpartum	Scale weight; Length and head circumference measurement

Trial Locations

Locations (18)

Binh Luc District Health Center - An Lao; 🇻🇳 Ha Nam, Vietnam

An Lao District Health Center - Quoc Tuan; 🇻🇳 Hai Phong, Vietnam

Phu Binh District Health Center - Tan Khanh; 🇻🇳 Thai Nguyen, Vietnam

An Lao District Health Center - Bat Trang; 🇻🇳 Hai Phong, Vietnam

An Lao District Health Centre- Truang Tho; 🇻🇳 Hai Phong, Vietnam

Yen Mo District Health Center - Yen Thanh; 🇻🇳 Ninh Binh, Vietnam

Binh Luc District Health Center - Binh Nghia; 🇻🇳 Ha Nam, Vietnam

Phu Binh District Health Center - Kha Son; 🇻🇳 Thai Nguyen, Vietnam

Phu Binh District Health Center - Tan Kim; 🇻🇳 Thai Nguyen, Vietnam

An Lao District Health Center - Thai Son; 🇻🇳 Hai Phong, Vietnam

Yen Mo District Health Center - Yen Hoa; 🇻🇳 Ninh Binh, Vietnam

An Lao District Health Centre- Quoc Trung; 🇻🇳 Hai Phong, Vietnam

Phu Binh District Health Centre- Tan Duc; 🇻🇳 Thai Nguyen, Vietnam

Bin Luc District Health Centre- Dong Du; 🇻🇳 Ha Nam, Vietnam

Binh Luc District Health Center - Trang An; 🇻🇳 Ha Nam, Vietnam

Yen Mo District Health Center - Yen Dong; 🇻🇳 Ninh Binh, Vietnam

Phu Binh District Health Centre- Xuan Phuong; 🇻🇳 Thai Nguyen, Vietnam

Phu Binh District Health Centre- Tan Hoa; 🇻🇳 Thai Nguyen, Vietnam