The Impact of a Breastfeeding Support Intervention on Breastfeeding Duration in Jaundiced Infants Admitted to a Tertiary Care Centre: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
研究概览
简要总结
Breastfeeding decreases the risk of many infantile infectious diseases and certain types of cancers in women. It strengthens the bond between mothers and babies and decreases the health care cost to society by making children healthier. Although it is controversial, breastfeeding has been reported to increase the risk of jaundice in the neonatal period. There is some evidence that mothers of hospitalized jaundiced infants discontinue breastfeeding early, as they feel responsible for the baby's condition.
The main objective of this study is to determine the effect of a breastfeeding intervention on breastfeeding duration in jaundiced infants. All eligible infants will be randomized to one of two groups (an intervention or a control group). Mothers of infants in the intervention group will meet with a lactation consultant during their hospital stay, and three times post hospital discharge. Lactation consultants are individuals who have received certification in breastfeeding support from an international board, ensuring safe and effective practice. Mothers of infants in the control group will receive the current standard of care, which is typically support from the nursing staff, who are often not trained in lactation support. Information will be collected on length of time that infants are fed only breast milk, future visits to health care providers, mothers' need for breastfeeding support post hospital discharge, mothers' perception of their physicians' attitudes towards breastfeeding, and mothers' experiences at the hospital, as well as feedback on the intervention. Phone follow-up will occur one week post hospital discharge, and when the child is 2, 3, 4 and 6 months old.
The results of this study will clarify the importance of offering sound breastfeeding advice to mothers of young infants hospitalized with jaundice and help determine whether there is a need for trained lactation specialists in children's hospitals. It will allow us to examine whether such an intervention can have a quantifiable impact on children's health in their first 6 months of life, as measured by physician encounters and hospitalizations. It will also allow collection of information on advice and support given to breastfeeding women by primary care physicians, potentially identifying needs for more rigorous breastfeeding training during medical training.
详细描述
1.1 Overview This study will assess the effectiveness of a breastfeeding support intervention for infants admitted to the hospital with jaundice. It will evaluate the effect of this intervention on duration of breastfeeding and health care utilization.
1.2 Study Objectives: Primary: To determine the effect of a breastfeeding support intervention on breastfeeding duration in breastfeeding infants admitted to the hospital with jaundice.
Secondary:
- To determine the rate of breastfeeding failure, defined as breastfeeding cessation before the infant turns 6 months, in mothers of jaundiced infants randomized to the control group, as compared to the rate of breastfeeding failure in the general population.
- To compare subsequent healthcare utilization between groups during their first six months of life, as determined by the number of re-hospitalizations for jaundice, hospitalizations for non-jaundice related causes, as well as physician encounters.
- To determine the number of mothers seeking breastfeeding help once discharged from the hospital and compare it between both groups.
- To determine the kind and perceived effectiveness of breastfeeding support and advice given by the infant's primary physician throughout the child's first six months of life.
2.1 Summary: Breastfeeding confers many advantages to infants, mothers, families, and society in general. There is strong evidence that human milk feeding decreases the incidence of many infectious diseases and enhances the immunologic status of the newborn. It has been associated with enhanced performance on neurocognitive development tests, and has also been shown to provide important health benefits to the mother, including a decrease in risk of breast and ovarian cancers. It should be strongly encouraged for the first six months of life, and then continued for up to 2 years and beyond, as recommended in the World Health Organization's Innocent Declaration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mothers of infants admitted during the study period with hyperbilirubinemia, breastfeeding at the time of admission (any amount of breastfeeding)
- •Mothers of infants < 1 month of age at the time of admission
排除标准
- •Mothers of infants admitted with hyperbilirubinemia who are exclusively formula-fed
- •Mothers of infants with hyperbilirubinemia of the predominantly conjugated type as this is a different disease, not associated with breastfeeding difficulties
- •Mothers of infants with anatomical abnormalities, such as cleft lip or palate, as this would interfere with breastfeeding and require more intensive intervention.
- •Mothers of neurologically impaired infants as breastfeeding may be more difficult in this population
- •Mother of infants who were admitted to the Neonatal Intensive Care Unit (NICU) after birth and never went home as they are likely to have other comorbidities affecting feeding.
- •Mothers of infants feeding via naso-gastric, naso-jejunal, or gastric tube
- •Mothers of infants > 1 month of age
- •Mothers who have had breast surgery in the past
- •Foster mothers or adoptive mothers
- •Mothers who do not understand English or French
- •Mothers of infants that are the result of multiple birth (eg twins)
结局指标
主要结局
Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
时间窗: 3 months
Exclusive breastfeeding was defined as no milk intake other than breast milk
次要结局
- Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely(3 months)
- Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely(6 months)
- Number of Participants With an Infant Re-hospitalized for Non-jaundice Related Causes in the First Six Months of Life(6 months)
- Number of Participants Partially Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely(6 months)
- Number of Participants With an Infant Re-hospitalized for Jaundice(6 months)
- Number of Physician Encounters in First 6 Months of Life(6 months)
- Number of Mothers Seeking Breastfeeding Help(6 months)
研究者
Catherine Pound
Consulting Pediatrician; Clinical Investigator, CHEO Research Institute
Children's Hospital of Eastern Ontario