Breastfeeding Intervention Study

May 23, 2016 updated by: Abbott Nutrition
To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ha Nam, 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
      • Hai Phong, 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
      • Ninh Binh, 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
      • Thai Nguyen, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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
Lactation support in conjunction with a maternal nutritional supplement S348S0
Dietary supplement: Maternal Nutritional Supplement
S348S0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding Rate
Time Frame: Week 12 postpartum
Week 12 postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Dieu Huynh, MD, PhD., Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • AL08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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