Breastfeeding Support Intervention in Jaundiced Infants

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00966719
First received: August 26, 2009
Last updated: May 22, 2013
Last verified: February 2010
  Purpose

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 Intervention
Jaundice
Breastfeeding
Other: Lactation Consultant support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
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.

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Exclusive breastfeeding at 3 months, or 3 months corrected if the infant was born prematurely. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exclusive breastfeeding at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Partial breastfeeding at three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Partial breastfeeding at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of re-hospitalization for jaundice in the first six months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of re-hospitalization for non-jaundice related causes in the first six months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of physician encounters in first 6 months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of mothers seeking breastfeeding help [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Amount and type of breastfeeding support given by child's primary physician in first six months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: October 2009
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 at the time of admission

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966719

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Catherine M Pound, MD Children's Hospital of Eastern Ontario and Research Institute
  More Information

Publications:
UNICEF-WHO. Innocenti Declaration. On the Protection, Promotion and Support of Breast-feeding. New York, NY:UNICEF;1990.
Howie PW, Forsyth JS, Ogston SA, et al. Protective effect of breastfeeding against infection. BMJ. 1990;300:11-16.

Responsible Party: Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00966719     History of Changes
Other Study ID Numbers: 09/23E
Study First Received: August 26, 2009
Last Updated: May 22, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:
Jaundice
Breastfeeding
Infants

Additional relevant MeSH terms:
Jaundice
Hyperbilirubinemia
Pathologic Processes
Signs and Symptoms
Skin Manifestations

ClinicalTrials.gov processed this record on October 30, 2014