Clinical trial NCT02016586: Breastfeeding Intervention Study
Official title: Breastfeeding Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 228
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Breastfeeding Rate
timeFrame: Week 12 postpartum
Secondary outcomes:
measure: Breastfeeding Rate
timeFrame: Week 4 postpartum
measure: Lactation Assessment
timeFrame: Week 4 postpartum
measure: Infant Anthropometrics
timeFrame: Week 4 postpartum
measure: Breastfeeding Rate
timeFrame: Week 8 postpartum
measure: Lactation Assessment
timeFrame: Week 8 postpartum
measure: Lactation Assessment
timeFrame: Week 12 postpartum
measure: Infant Anthropometrics
timeFrame: Week 8 postpartum
measure: Infant Anthropometrics
timeFrame: Week 12 postpartum
Other outcomes:
Locations:
city: Ha Nam
country: Vietnam
facility: Bin Luc District Health Centre- Dong Du
city: Ha Nam
country: Vietnam
facility: Binh Luc District Health Center - An Lao
city: Ha Nam
country: Vietnam
facility: Binh Luc District Health Center - Binh Nghia
city: Ha Nam
country: Vietnam
facility: Binh Luc District Health Center - Trang An
city: Hai Phong
country: Vietnam
facility: An Lao District Health Center - Bat Trang
city: Hai Phong
country: Vietnam
facility: An Lao District Health Center - Quoc Tuan
city: Hai Phong
country: Vietnam
facility: An Lao District Health Center - Thai Son
city: Hai Phong
country: Vietnam
facility: An Lao District Health Centre- Quoc Trung
city: Hai Phong
country: Vietnam
facility: An Lao District Health Centre- Truang Tho
city: Ninh Binh
country: Vietnam
facility: Yen Mo District Health Center - Yen Dong
city: Ninh Binh
country: Vietnam
facility: Yen Mo District Health Center - Yen Hoa
city: Ninh Binh
country: Vietnam
facility: Yen Mo District Health Center - Yen Thanh
city: Thai Nguyen
country: Vietnam
facility: Phu Binh District Health Center - Kha Son
city: Thai Nguyen
country: Vietnam
facility: Phu Binh District Health Center - Tan Khanh
city: Thai Nguyen
country: Vietnam
facility: Phu Binh District Health Center - Tan Kim
city: Thai Nguyen
country: Vietnam
facility: Phu Binh District Health Centre- Tan Duc
city: Thai Nguyen
country: Vietnam
facility: Phu Binh District Health Centre- Tan Hoa
city: Thai Nguyen
country: Vietnam
facility: Phu Binh District Health Centre- Xuan Phuong
Study officials:
affiliation: Abbott Nutrition
name: Dieu Huynh, MD, PhD.
role: STUDY_CHAIR
References:
citation: Tran NT, Nguyen LT, Berde Y, Low YL, Tey SL, Huynh DTT. Maternal nutritional adequacy and gestational weight gain and their associations with birth outcomes among Vietnamese women. BMC Pregnancy Childbirth. 2019 Dec 4;19(1):468. doi: 10.1186/s12884-019-2643-6.