Breastfeeding Intervention Study

Breast Feeding Clinical Trial

Official title:

Breastfeeding Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016586
• Other study ID #: AL08
• Status: Completed
• Phase: N/A
• First received: November 29, 2013
• Last updated: May 23, 2016
• Start date: November 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Dietary Supplement:
• Maternal Nutritional Supplement
S348S0

Locations

Country	Name	City	State
Vietnam	Bin Luc District Health Centre- Dong Du	Ha Nam
Vietnam	Binh Luc District Health Center - An Lao	Ha Nam
Vietnam	Binh Luc District Health Center - Binh Nghia	Ha Nam
Vietnam	Binh Luc District Health Center - Trang An	Ha Nam
Vietnam	An Lao District Health Center - Bat Trang	Hai Phong
Vietnam	An Lao District Health Center - Quoc Tuan	Hai Phong
Vietnam	An Lao District Health Center - Thai Son	Hai Phong
Vietnam	An Lao District Health Centre- Quoc Trung	Hai Phong
Vietnam	An Lao District Health Centre- Truang Tho	Hai Phong
Vietnam	Yen Mo District Health Center - Yen Dong	Ninh Binh
Vietnam	Yen Mo District Health Center - Yen Hoa	Ninh Binh
Vietnam	Yen Mo District Health Center - Yen Thanh	Ninh Binh
Vietnam	Phu Binh District Health Center - Kha Son	Thai Nguyen
Vietnam	Phu Binh District Health Center - Tan Khanh	Thai Nguyen
Vietnam	Phu Binh District Health Center - Tan Kim	Thai Nguyen
Vietnam	Phu Binh District Health Centre- Tan Duc	Thai Nguyen
Vietnam	Phu Binh District Health Centre- Tan Hoa	Thai Nguyen
Vietnam	Phu Binh District Health Centre- Xuan Phuong	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	Breastfeeding Rate		Week 12 postpartum	No
Secondary	Breastfeeding Rate		Week 4 postpartum	No
Secondary	Lactation Assessment	Maternal completed questionnaire with visual analogue scales	Week 4 postpartum	No
Secondary	Infant Anthropometrics	Scale weight; Length and head circumference measurement	Week 4 postpartum	No
Secondary	Breastfeeding Rate		Week 8 postpartum	No
Secondary	Lactation Assessment	Maternal completed questionnaire with visual analogue scales	Week 8 postpartum	No
Secondary	Lactation Assessment	Maternal completed questionnaire with visual analogue scales	Week 12 postpartum	No
Secondary	Infant Anthropometrics	Scale weight; Length and head circumference measurement	Week 8 postpartum	No
Secondary	Infant Anthropometrics	Scale weight; Length and head circumference measurement	Week 12 postpartum	No