Responsive Feeding of Infants With Expressed Milk
- Conditions
- BreastfeedingFeeding BehaviorHuman Milk
- Interventions
- Behavioral: (feeding modality)
- Registration Number
- NCT04041505
- Lead Sponsor
- Mount Saint Vincent University
- 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 formula, breastfeeding has been linked with a number of health advantages, including fewer infections, higher IQ, and a lowered risk of obesity later in life.
How infants consume human milk is changing. Pumping milk has grown in popularity in recent years because some mothers may feel stigmatized breastfeeding, especially in public, but also because it allows other caregivers to help with feeding. Although pumped human milk is considered equal to breastfeeding, there is very little research in this area, especially around responsive feeding and later health outcomes. Since pumped milk is fed from a bottle, the health benefits may be lost (for instance, this may impact a baby's ability to understand if s/he is hungry or full).
The primary aim of this study is to determine if the volume of human milk an infant consumes differs if they consume milk from a bottle versus the breast. The investigators will conduct a cross-over trial in which 62 mother-infant pairs will be randomized to feed at the breast or from a bottle for 24 hours, have a 24 hour wash-out period, and then 'cross-over' to another 24 hour session with the opposite 'treatment.' The volume of milk consumed at each feed within the 24 hour window (via indirect weighing, or weighing the baby before and after eating) will be recorded to determine if there are differences in milk consumption. Mother-infant pairs will complete this 3-day study three times, at 6 weeks, 4 months, and 6 months.
Information from this study will help to better understand current infant feeding practices in Nova Scotia, and the potential role this plays in future health outcomes. Evidence from this study may help to identify means of improving feeding practices and promoting human milk as the main food for Nova Scotian infants, setting them on a path for the best start in life.
- Detailed Description
See attached full protocol document for full details.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Breastfeeding (feeding modality) Infant consumes mother's milk directly from the breast. Bottle-feeding (feeding modality) Infant consumes mother's expressed milk from a bottle.
- Primary Outcome Measures
Name Time Method Volume of milk consumption 24 hours To assess if the volume of human milk consumed by infants differs by feeding modality (bottle feeding human milk versus breastfeeding), assessed as overall milk volume consumed over 24 hours, measured by indirect weighs at each feed during a 24-hour period.
- Secondary Outcome Measures
Name Time Method Responsive feeding behaviors Between 6 weeks and 6 months To objectively assess responsiveness of infant feeding practices, both at the breast and during bottle-feeding of human milk, by video-recording feeding sessions in participant's homes.
Infant growth Between 6 weeks and 6 months To determine whether change in infant anthropometric measurements (length in cm, weight in kg, head circumference in cm) and growth rates (weight-for-age \[WAZ\], length-for-age \[LAZ\], weight-for-length \[WLZ\], BMI-for-age z-scores \[BAZ\]; all computed as z-scores) differ by self-reported usual feeding modality among infants exclusively consuming human milk.
Trial Locations
- Locations (1)
MAMA Lab, Mount Saint Vincent University
🇨🇦Halifax, Nova Scotia, Canada