Breastfeeding Intervention Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Abbott Nutrition
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT02016586
First received: November 29, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Lactation Support
Other: Maternal Control
Other: Maternal Nutritional Supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Breastfeeding Intervention Study

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Breastfeeding Rate [ Time Frame: Week 12 postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breastfeeding Rate [ Time Frame: Week 4 postpartum ] [ Designated as safety issue: No ]
  • Lactation Assessment [ Time Frame: Week 4 postpartum ] [ Designated as safety issue: No ]
    Maternal completed questionnaire with visual analogue scales

  • Infant Anthropometrics [ Time Frame: Week 4 postpartum ] [ Designated as safety issue: No ]
    Scale weight; Length and head circumference measurement

  • Breastfeeding Rate [ Time Frame: Week 8 postpartum ] [ Designated as safety issue: No ]
  • Lactation Assessment [ Time Frame: Week 8 postpartum ] [ Designated as safety issue: No ]
    Maternal completed questionnaire with visual analogue scales

  • Lactation Assessment [ Time Frame: Week 12 postpartum ] [ Designated as safety issue: No ]
    Maternal completed questionnaire with visual analogue scales

  • Infant Anthropometrics [ Time Frame: Week 8 postpartum ] [ Designated as safety issue: No ]
    Scale weight; Length and head circumference measurement

  • Infant Anthropometrics [ Time Frame: Week 12 postpartum ] [ Designated as safety issue: No ]
    Scale weight; Length and head circumference measurement


Estimated Enrollment: 228
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Maternal Control
Standard of pre- and postnatal care
Other: Maternal Control
Standard of pre- and postnatal care
Experimental: Maternal Nutritional Supplement Other: Maternal Nutritional Supplement
maternal nutritional supplement S348S0

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016586

Contacts
Contact: Kristen DeLuca, MS, RD 614-624-5455 kristen.deluca@abbott.com
Contact: Bobbie Swearengin, RN 614-624-7182 bobbie.swearengin@abbott.com

Locations
Vietnam
Binh Luc District Health Center - An Lao Not yet recruiting
Ha Nam, Vietnam
Principal Investigator: Thoang Dang, MD         
Binh Luc District Health Center - Trang An Not yet recruiting
Ha Nam, Vietnam
Principal Investigator: Thoang Dang, MD         
Binh Luc District Health Center - Binh Nghia Not yet recruiting
Ha Nam, Vietnam
Principal Investigator: Thoang Dang, MD         
An Lao District Health Center - Quoc Tuan Not yet recruiting
Hai Phong, Vietnam
Principal Investigator: Luu Nguyen, MD         
An Lao District Health Center - Thai Son Not yet recruiting
Hai Phong, Vietnam
Principal Investigator: Luu Nguyen, MD         
An Lao District Health Center - Bat Trang Not yet recruiting
Hai Phong, Vietnam
Principal Investigator: Luu Nguyen, MD         
Yen Mo District Health Center - Yen Dong Not yet recruiting
Ninh Binh, Vietnam
Principal Investigator: Quy Ninh, MD         
Yen Mo District Health Center - Yen Hoa Not yet recruiting
Ninh Binh, Vietnam
Principal Investigator: Quy Ninh, MD         
Yen Mo District Health Center - Yen Thanh Not yet recruiting
Ninh Binh, Vietnam
Principal Investigator: Quy Ninh, MD         
Phu Binh District Health Center - Tan Khanh Not yet recruiting
Thai Nguyen, Vietnam
Principal Investigator: Thu Nguyen, MD         
Phu Binh District Health Center - Tan Kim Not yet recruiting
Thai Nguyen, Vietnam
Principal Investigator: Thu Nguyen, MD         
Phu Binh District Health Center - Kha Son Not yet recruiting
Thai Nguyen, Vietnam
Principal Investigator: Thu Nguyen, MD         
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Dieu Huynh, MD, PhD. Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02016586     History of Changes
Other Study ID Numbers: AL08
Study First Received: November 29, 2013
Last Updated: December 16, 2013
Health Authority: Vietnam: Ministry of Health

ClinicalTrials.gov processed this record on October 01, 2014