Clinical Trial: Breastfeeding Support Intervention in Jaundiced Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Impact of a Breastfeeding Support Intervention on Breastfeeding Duration in Jaundiced Infants Admitted to a Tertiary Care Centre: a Randomized Controlled Trial.

Brief Summary:

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

Detailed Summary:

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
Sponsor: Children's Hospital of Eastern Ontario

Current Primary Outcome: Exclusive breastfeeding at 3 months, or 3 months corrected if the infant was born prematurely. [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Exclusive breastfeeding at six months [ Time Frame: 6 months ]
  • Partial breastfeeding at three months [ Time Frame: 3 months ]
  • Partial breastfeeding at six months [ Time Frame: 6 months ]
  • Number of re-hospitalization for jaundice in the first six months of life [ Time Frame: 6 months ]
  • Number of re-hospitalization for non-jaundice related causes in the first six months of life [ Time Frame: 6 months ]
  • Number of physician encounters in first 6 months of life [ Time Frame: 6 months ]
  • Number of mothers seeking breastfeeding help [ Time Frame: 6 months ]
  • Amount and type of breastfeeding support given by child's primary physician in first six months of life [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Eastern Ontario

Dates:
Date Received: August 26, 2009
Date Started: October 2009
Date Completion:
Last Updated: January 28, 2016
Last Verified: January 2016