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Interim analysis (n=40 24-hr sessions) yielded biologically implausible data. We do not deem this novel, at-home, participant-led method prudent. Study will continue with only secondary objectives; primary objective (RCT) terminated.
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| Name | Class |
|---|---|
| University of Prince Edward Island | OTHER |
| Queen's University | OTHER |
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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.
See attached full protocol document for full details.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding | Active Comparator | Infant consumes mother's milk directly from the breast. |
|
| Bottle-feeding | Experimental | Infant consumes mother's expressed milk from a bottle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (feeding modality) | Behavioral | The intervention is a change in feeding modality: in both arms, infant's will consume mother's milk. The difference in arms is the modality in which human milk is consumed: either directly from the breast, or from a bottle. |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of milk consumption | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Infant growth | 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. | Between 6 weeks and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding environment | To gain a better understanding of current infant feeding practices, including responsive feeding, among caregivers in the Halifax Regional Municipality, contextualize why women are pumping, and gain insight around how human milk is handled, stored, and prepared through open-ended one-on-one interviews with mothers. | Between 6 weeks and 6 months |
Inclusion criteria: Mother-infant dyads are eligible to participate if:
Exclusion criteria: Mother-infant dyads are ineligible to participate if:
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| Name | Affiliation | Role |
|---|---|---|
| Kyly C Whitfield, PhD | Mount Saint Vincent University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAMA Lab, Mount Saint Vincent University | Halifax | Nova Scotia | B3M2J6 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 27, 2019 | Sep 27, 2019 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001522 | Behavior, Animal |
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This is a modified, randomized cross-over study. The 'intervention' in this study is simply feeding infants using one of two modalities that are already familiar to the mother and infant: feeding mother's milk from the breast and from a bottle.
At each timepoint (6 weeks, 4 months, 6 months) infants will: be randomized using a balanced design (to control for order effect) to consume human milk from a bottle or from the breast for 24 hours; will then undergo a wash-out period in which they will be fed human milk as they usually would for 24 hours; then will complete the second 'treatment' (bottle or breast) for 24 hours. Due to the nature of the intervention, this study will not be blinded.
We aim to recruit 62 mother-infant pairs (= 124 participants in total).
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| Responsive feeding behaviors | 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. | Between 6 weeks and 6 months |