Status:
TERMINATED
Responsive Feeding of Infants With Expressed Milk
Lead Sponsor:
Mount Saint Vincent University
Collaborating Sponsors:
University of Prince Edward Island
Queen's University
Conditions:
Human Milk
Breastfeeding
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Nova Scotia has among the lowest breastfeeding rates in Canada, with less than one quarter of infants receiving Health Canada's recommended 6 months of exclusive breastfeeding. Compared with feeding f...
Detailed Description
See attached full protocol document for full details.
Eligibility Criteria
Inclusion
- Inclusion criteria: Mother-infant dyads are eligible to participate if:
- mother is aged 19 years or older,
- dyads currently live in the Halifax Regional Municipality in Nova Scotia,
- mother has no chronic diseases,
- the baby is a healthy singleton baby who is younger than 6 weeks of age, and is fed mother's milk directly from the breast and from a bottle,
- mother plans to exclusively feed their baby mother's own milk up to 6 months,
- mother has/had an older child whom they successfully fed mother's own milk for a minimum of 6 months,
- mother is willing to participate in three 3-day study sessions and monthly measurement sessions, and
- mother provides informed consent for herself and her infant to participate.
- Exclusion criteria: Mother-infant dyads are ineligible to participate if:
- the baby was born preterm (earlier than 37 weeks gestation),
- the baby was born outside the healthy weight range of 2,500 - 4,000 g (5lb 8oz to 8lb 13oz),
- the baby has a developmental delay diagnosed before the time of enrolment,
- the baby is currently receiving any medical treatment except for vitamin D supplementation (no more than 400 IU/day),
- the mother sought prescription medical treatment for lactation (e.g. domperidone, antibiotics, prescription nipple ointment), or
- the mother plans to move in the 6 months after starting the study.
Exclusion
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04041505
Start Date
August 15 2019
End Date
March 30 2020
Last Update
May 19 2021
Active Locations (1)
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1
MAMA Lab, Mount Saint Vincent University
Halifax, Nova Scotia, Canada, B3M2J6