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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
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Catherine Pound, Children's Hospital of Eastern Ontario

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Other
Conditions Jaundice
Breastfeeding
Intervention Other: Lactation Consultant support
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description

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
Arm/Group Title Lactation Consultant Current Treatment for Jaundice Total
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
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
Number Analyzed 50 participants 49 participants 99 participants
Female
50
 100.0%
49
 100.0%
99
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
language  
Measure Type: Number
Unit of measure:  Participants
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
Completed high school Number Analyzed 50 participants 49 participants 99 participants
4
   8.0%
4
   8.2%
8
   8.1%
Vocational / technical training (post high school) Number Analyzed 50 participants 49 participants 99 participants
13
  26.0%
13
  26.5%
26
  26.3%
Some university training Number Analyzed 50 participants 49 participants 99 participants
5
  10.0%
4
   8.2%
9
   9.1%
Completed university Number Analyzed 50 participants 49 participants 99 participants
28
  56.0%
28
  57.1%
56
  56.6%
combined household income  
Measure Type: Count of Participants
Unit of measure:  Participants
Under $30,000 Number Analyzed 50 participants 49 participants 99 participants
4
   8.0%
7
  14.3%
11
  11.1%
$30,000 - $69,000 Number Analyzed 50 participants 49 participants 99 participants
8
  16.0%
9
  18.4%
17
  17.2%
$70,000 - $100,000 Number Analyzed 50 participants 49 participants 99 participants
10
  20.0%
12
  24.5%
22
  22.2%
Above $100,000 Number Analyzed 50 participants 49 participants 99 participants
21
  42.0%
18
  36.7%
39
  39.4%
Declined to answer Number Analyzed 50 participants 49 participants 99 participants
6
  12.0%
2
   4.1%
8
   8.1%
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%
marital status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
marries / common-law
45
  90.0%
47
  95.9%
92
  92.9%
single
5
  10.0%
1
   2.0%
6
   6.1%
unknown
0
   0.0%
1
   2.0%
1
   1.0%
number of prior children  
Measure Type: Count of Participants
Unit of measure:  Participants
none Number Analyzed 50 participants 49 participants 99 participants
22
  44.0%
31
  63.3%
53
  53.5%
1 Number Analyzed 50 participants 49 participants 99 participants
22
  44.0%
14
  28.6%
36
  36.4%
>1 Number Analyzed 50 participants 49 participants 99 participants
6
  12.0%
8
  16.3%
14
  14.1%
number of prior breastfed children  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
0
24
  48.0%
31
  63.3%
55
  55.6%
1
23
  46.0%
15
  30.6%
38
  38.4%
>1
3
   6.0%
3
   6.1%
6
   6.1%
received breastfeeding support with prior infants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
14
  28.0%
15
  30.6%
29
  29.3%
infant received formula prior to hospitalization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
27
  54.0%
22
  44.9%
49
  49.5%
received medical care from:  
Measure Type: Number
Unit of measure:  Participants
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
Number Analyzed 50 participants 49 participants 99 participants
17
  34.0%
21
  42.9%
38
  38.4%
planning to return to work before child is 1 year of age  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
10
  20.0%
12
  24.5%
22
  22.2%
1.Primary Outcome
Title Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
Hide Description Exclusive breastfeeding was defined as no milk intake other than breast milk
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description

50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module

49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module

Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 45 41
Measure Type: Count of Participants
Unit of Measure: Participants
22
  48.9%
24
  58.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.56 to 1.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely
Hide Description Exclusive breastfeeding was defined as no milk intake other than breast milk
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module

49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module

Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 44 38
Measure Type: Count of Participants
Unit of Measure: Participants
8
  18.2%
6
  15.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.44 to 3.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
Hide Description Partial breastfeeding was defined as any feeding of breast milk
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 45 41
Measure Type: Count of Participants
Unit of Measure: Participants
43
  95.6%
39
  95.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1
Confidence Interval (2-Sided) 95%
0.91 to 1.10
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Partially Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely
Hide Description Partial breastfeeding was defined as any amount of feeding breast milk
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module

49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module

Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 44 38
Measure Type: Count of Participants
Unit of Measure: Participants
37
  84.1%
31
  81.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.85 to 1.26
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With an Infant Re-hospitalized for Jaundice
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 50 49
Measure Type: Count of Participants
Unit of Measure: Participants
3
   6.0%
1
   2.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.94
Confidence Interval (2-Sided) 95%
0.32 to 27.30
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With an Infant Re-hospitalized for Non-jaundice Related Causes in the First Six Months of Life
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 50 49
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.0%
3
   6.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.95 to 2.38
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Physician Encounters in First 6 Months of Life
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 50 49
Mean (Inter-Quartile Range)
Unit of Measure: physician encounters
9.2
(6 to 12)
9.9
(6.3 to 12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.83 to 1.27
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Mothers Seeking Breastfeeding Help
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module

49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module

Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description:

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)
Overall Number of Participants Analyzed 44 38
Measure Type: Count of Participants
Unit of Measure: Participants
11
  25.0%
7
  18.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactation Consultant, Current Treatment for Jaundice
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.58 to 3.15
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lactation Consultant Current Treatment for Jaundice
Hide Arm/Group Description

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)
All-Cause Mortality
Lactation Consultant Current Treatment for Jaundice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Lactation Consultant Current Treatment for Jaundice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/49 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactation Consultant Current Treatment for Jaundice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/49 (0.00%) 
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).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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
Layout table for additonal information
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