Breastfeeding Support Intervention in Jaundiced Infants
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ClinicalTrials.gov Identifier: NCT00966719 |
Recruitment Status :
Completed
First Posted : August 27, 2009
Results First Posted : March 28, 2019
Last Update Posted : April 17, 2019
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Sponsor:
Children's Hospital of Eastern Ontario
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Catherine Pound, Children's Hospital of Eastern Ontario
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Other |
Conditions |
Jaundice Breastfeeding |
Intervention |
Other: Lactation Consultant support |
Enrollment | 99 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Lactation Consultant | Current Treatment for Jaundice |
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In hospital meeting with lactation consultant 1 to 3 follow up visits at weekly intervals with lactation consultant 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. |
Babies will receive current standard of care for jaundice (IV fluids and phototherapy) |
Period Title: Overall Study | ||
Started | 50 | 49 |
Completed | 44 | 38 |
Not Completed | 6 | 11 |
Reason Not Completed | ||
Lost to Follow-up | 6 | 11 |
Baseline Characteristics
Arm/Group Title | Lactation Consultant | Current Treatment for Jaundice | Total | |
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In hospital meeting with lactation consultant 1 to 3 follow up visits at weekly intervals with lactation consultant 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. |
Babies will receive current standard of care for jaundice (IV fluids and phototherapy) | Total of all reporting groups | |
Overall Number of Baseline Participants | 50 | 49 | 99 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
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15-20 years | Number Analyzed | 50 participants | 49 participants | 99 participants |
2 | 0 | 2 | ||
21-25 years | Number Analyzed | 50 participants | 49 participants | 99 participants |
6 | 9 | 15 | ||
26-30 years | Number Analyzed | 50 participants | 49 participants | 99 participants |
11 | 13 | 24 | ||
31-35 years | Number Analyzed | 50 participants | 49 participants | 99 participants |
23 | 18 | 41 | ||
36-40 years | Number Analyzed | 50 participants | 49 participants | 99 participants |
6 | 7 | 13 | ||
>40 years | Number Analyzed | 50 participants | 49 participants | 99 participants |
2 | 2 | 4 | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 49 participants | 99 participants | |
Female |
50 100.0%
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49 100.0%
|
99 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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language
Measure Type: Number Unit of measure: Participants |
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English | Number Analyzed | 50 participants | 49 participants | 99 participants |
50 | 43 | 93 | ||
French | Number Analyzed | 50 participants | 49 participants | 99 participants |
0 | 6 | 49 | ||
highest level of education completed
Measure Type: Count of Participants Unit of measure: Participants |
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Completed high school | Number Analyzed | 50 participants | 49 participants | 99 participants |
4 8.0%
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4 8.2%
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8 8.1%
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Vocational / technical training (post high school) | Number Analyzed | 50 participants | 49 participants | 99 participants |
13 26.0%
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13 26.5%
|
26 26.3%
|
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Some university training | Number Analyzed | 50 participants | 49 participants | 99 participants |
5 10.0%
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4 8.2%
|
9 9.1%
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Completed university | Number Analyzed | 50 participants | 49 participants | 99 participants |
28 56.0%
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28 57.1%
|
56 56.6%
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combined household income
Measure Type: Count of Participants Unit of measure: Participants |
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Under $30,000 | Number Analyzed | 50 participants | 49 participants | 99 participants |
4 8.0%
|
7 14.3%
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11 11.1%
|
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$30,000 - $69,000 | Number Analyzed | 50 participants | 49 participants | 99 participants |
8 16.0%
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9 18.4%
|
17 17.2%
|
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$70,000 - $100,000 | Number Analyzed | 50 participants | 49 participants | 99 participants |
10 20.0%
|
12 24.5%
|
22 22.2%
|
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Above $100,000 | Number Analyzed | 50 participants | 49 participants | 99 participants |
21 42.0%
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18 36.7%
|
39 39.4%
|
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Declined to answer | Number Analyzed | 50 participants | 49 participants | 99 participants |
6 12.0%
|
2 4.1%
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8 8.1%
|
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mother smokes at home
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 50 participants | 49 participants | 99 participants | |
1 2.0%
|
0 0.0%
|
1 1.0%
|
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marital status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 49 participants | 99 participants | |
marries / common-law |
45 90.0%
|
47 95.9%
|
92 92.9%
|
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single |
5 10.0%
|
1 2.0%
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6 6.1%
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unknown |
0 0.0%
|
1 2.0%
|
1 1.0%
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number of prior children
Measure Type: Count of Participants Unit of measure: Participants |
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none | Number Analyzed | 50 participants | 49 participants | 99 participants |
22 44.0%
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31 63.3%
|
53 53.5%
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1 | Number Analyzed | 50 participants | 49 participants | 99 participants |
22 44.0%
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14 28.6%
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36 36.4%
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>1 | Number Analyzed | 50 participants | 49 participants | 99 participants |
6 12.0%
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8 16.3%
|
14 14.1%
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number of prior breastfed children
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 49 participants | 99 participants | |
0 |
24 48.0%
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31 63.3%
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55 55.6%
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1 |
23 46.0%
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15 30.6%
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38 38.4%
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>1 |
3 6.0%
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3 6.1%
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6 6.1%
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received breastfeeding support with prior infants
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 49 participants | 99 participants | |
14 28.0%
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15 30.6%
|
29 29.3%
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infant received formula prior to hospitalization
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 49 participants | 99 participants | |
27 54.0%
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22 44.9%
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49 49.5%
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received medical care from:
Measure Type: Number Unit of measure: Participants |
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obstetrician | Number Analyzed | 50 participants | 49 participants | 99 participants |
32 | 29 | 61 | ||
family physician | Number Analyzed | 50 participants | 49 participants | 99 participants |
29 | 21 | 50 | ||
midwife | Number Analyzed | 50 participants | 49 participants | 99 participants |
8 | 15 | 23 | ||
no prenatal care | Number Analyzed | 50 participants | 49 participants | 99 participants |
3 | 0 | 3 | ||
attended prenatal classes
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 49 participants | 99 participants | |
17 34.0%
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21 42.9%
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38 38.4%
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planning to return to work before child is 1 year of age
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | 49 participants | 99 participants | |
10 20.0%
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12 24.5%
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22 22.2%
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Outcome Measures
Adverse Events
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).
More Information
Results Point of Contact
Name/Title: | Dr Catherine Pound |
Organization: | Children's Hospital of Eastern Ontario |
Phone: | 613-737-7600 |
EMail: | cpound@cheo.on.ca |
Publications:
UNICEF-WHO. Innocenti Declaration. On the Protection, Promotion and Support of Breast-feeding. New York, NY:UNICEF;1990.
Canadian Paediatric Society, Dietitians of Canada and Health Canada. Nutrition for Healthy Term Infants. 1998. Ottawa: Minister of Public Works and Government Services, 1998
Health Canada. Exclusive Breastfeeding Duration: 2004 Health Canada Recommendation. Ottawa, 2004. www.hc-sc.gc.ca/hpfb-dgpsa/onpp-bppn/exclusive_breastfeeding_duration_e.html
World Health Organization. Global Strategy for Infant and Young Child Feeding, The Optimal Duration of Exclusive Breastfeeding. Geneva, 2001. www.who.int/gb/ebwha/pdf_files/WHA54/ea54id4.pdf
City of Ottawa, Ottawa Public Health. Infant Care Survey 2005
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Catherine Pound, Children's Hospital of Eastern Ontario |
ClinicalTrials.gov Identifier: | NCT00966719 |
Other Study ID Numbers: |
09/23E |
First Submitted: | August 26, 2009 |
First Posted: | August 27, 2009 |
Results First Submitted: | April 26, 2018 |
Results First Posted: | March 28, 2019 |
Last Update Posted: | April 17, 2019 |