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N/A N=99 Randomized Single-blind Other

Breastfeeding Support Intervention in Jaundiced Infants

Jaundice · Breastfeeding

Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely — 22; 24 Participants — p=0.40

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lactation Consultant support (Other)
Age
Pediatric
Sex
All
Sponsor
Children's Hospital of Eastern Ontario
Primary completion
Jan 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
22; 24 0.40
SECONDARY
Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely
8; 6 1
SECONDARY
Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
43; 39 1
SECONDARY
Number of Participants Partially Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely
37; 31 0.78
SECONDARY
Number of Participants With an Infant Re-hospitalized for Jaundice
3; 1 0.32
SECONDARY
Number of Participants With an Infant Re-hospitalized for Non-jaundice Related Causes in the First Six Months of Life
2; 3 0.09
SECONDARY
Number of Physician Encounters in First 6 Months of Life
9.2; 9.9 0.77
SECONDARY
Number of Mothers Seeking Breastfeeding Help
11; 7 0.6

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 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.

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00966719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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