Feeding Infants in Nova Scotia: an Exploratory Analysis of Responsive Feeding With Mother's Milk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Volume of milk consumption
研究概览
简要总结
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.
详细描述
See attached full protocol document for full details.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Breastfeeding
Infant consumes mother's milk directly from the breast.
干预措施: (feeding modality) (Behavioral)
Bottle-feeding
Infant consumes mother's expressed milk from a bottle.
干预措施: (feeding modality) (Behavioral)
结局指标
主要结局
Volume of milk consumption
时间窗: 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.
次要结局
- Infant growth(Between 6 weeks and 6 months)
- Responsive feeding behaviors(Between 6 weeks and 6 months)