Breastfeeding Support Intervention in Jaundiced Infants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00966719|
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : March 28, 2019
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Jaundice Breastfeeding||Other: Lactation Consultant support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||April 2013|
Active Comparator: Lactation Consultant
In hospital meeting with lactation consultant
1 to 3 follow up visits at weekly intervals with lactation consultant
Other: Lactation Consultant support
Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice.
Other Name: Breastfeeding support
No Intervention: current treatment for jaundice
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
- Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely [ Time Frame: 3 months ]Exclusive breastfeeding was defined as no milk intake other than breast milk
- Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely [ Time Frame: 6 months ]Exclusive breastfeeding was defined as no milk intake other than breast milk
- Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely [ Time Frame: 3 months ]Partial breastfeeding was defined as any feeding of breast milk
- Number of Participants Partially Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely [ Time Frame: 6 months ]Partial breastfeeding was defined as any amount of feeding breast milk
- Number of Participants With an Infant Re-hospitalized for Jaundice [ Time Frame: 6 months ]
- Number of Participants With an Infant Re-hospitalized 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966719
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H8L1|
|Principal Investigator:||Catherine M Pound, MD||Children's Hospital of Eastern Ontario and Research Institute|