Breastfeeding Support Intervention in Jaundiced Infants

NCT00966719 | Completed Results

• 1 other identifier: 09/23E
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Jaundice; Breastfeeding

Keywords

Jaundice; Breastfeeding; Infants

Outcome Measures

Primary Outcomes (1)

• Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely

  Exclusive breastfeeding was defined as no milk intake other than breast milk

  3 months

Secondary Outcomes (7)

• Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely

  6 months

• Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely

  3 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 Participants With an Infant Re-hospitalized for Non-jaundice Related Causes in the First Six Months of Life

  6 months

Study Arms (2)

Lactation Consultant

ACTIVE COMPARATOR

In hospital meeting with lactation consultant 1 to 3 follow up visits at weekly intervals with lactation consultant

Other: Lactation Consultant support

current treatment for jaundice

NO INTERVENTION

Babies will receive current standard of care for jaundice (IV fluids and phototherapy)

Interventions

Lactation Consultant support OTHER

Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice.

Also known as: Breastfeeding support

Lactation Consultant

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

Location

Related Publications (45)

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  PMID: 25747308 DERIVED

MeSH Terms

Conditions

Jaundice; Breast Feeding

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Feeding Behavior; Behavior

Limitations and Caveats

Difficult recruitment Large CI around our risk ratio (0.56 to 1.24) for primary outcome women with a strong desire to breastfeed more likely to enrol (breastfeeding proportions in control much higher than in general population).

Results Point of Contact

• Title: Dr Catherine Pound
• Organization: Children's Hospital of Eastern Ontario

cpound@cheo.on.ca

613-737-7600

Study Officials

• Catherine M Pound, MD

  Children's Hospital of Eastern Ontario and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consulting Pediatrician; Clinical Investigator, CHEO Research Institute

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 17, 2019
• Results First Posted: March 28, 2019

Record last verified: 2019-04

Locations

CA (1)