Breastfeeding Intervention Study

Abbott Nutrition18 sites in 1 country228 target enrollmentNovember 2013

ConditionsBreast Feeding

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Feeding
Sponsor: Abbott Nutrition
Enrollment: 228
Locations: 18
Primary Endpoint: Breastfeeding Rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

May 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Mother with singleton pregnancy at 26 to 29 weeks of gestation.
•Mother is between 20 and 35 years of age.
•Mother pre-pregnant BMI \< 25.0 kg/m
•Mother is first-time mother.
•Mother is contactable by telephone.
•Mother is non-smoker.
•Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
•Infant's birth weight was \> 2500 g.
•Infant is judged to be in good health.
•Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period.

Exclusion Criteria

•Mother is allergic or intolerant to any ingredient found in the study product.
•An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development.
•Mother has gestational diabetes and/or pre-eclampsia.
•Mother with contraindications to breastfeeding.
•Gestational weight gain is greater than 14 kg at enrollment.
•Mother had a breast surgery.
•Mother and/or newborn infant has major illness that requires intensive care admission.
•Infant has major congenital anomaly.