Trial Outcomes & Findings for Breastfeeding Support Intervention in Jaundiced Infants (NCT NCT00966719)
NCT ID: NCT00966719
Last Updated: 2019-04-17
Results Overview
Exclusive breastfeeding was defined as no milk intake other than breast milk
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
3 months
Results posted on
2019-04-17
Participant Flow
Participant milestones
| Measure |
Lactation Consultant
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.
|
Current Treatment for Jaundice
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
COMPLETED
|
44
|
38
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
| Measure |
Lactation Consultant
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.
|
Current Treatment for Jaundice
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lactation Consultant
n=50 Participants
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.
|
Current Treatment for Jaundice
n=49 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15-20 years
|
2 participants
n=50 Participants
|
0 participants
n=49 Participants
|
2 participants
n=99 Participants
|
|
Age, Customized
21-25 years
|
6 participants
n=50 Participants
|
9 participants
n=49 Participants
|
15 participants
n=99 Participants
|
|
Age, Customized
26-30 years
|
11 participants
n=50 Participants
|
13 participants
n=49 Participants
|
24 participants
n=99 Participants
|
|
Age, Customized
31-35 years
|
23 participants
n=50 Participants
|
18 participants
n=49 Participants
|
41 participants
n=99 Participants
|
|
Age, Customized
36-40 years
|
6 participants
n=50 Participants
|
7 participants
n=49 Participants
|
13 participants
n=99 Participants
|
|
Age, Customized
>40 years
|
2 participants
n=50 Participants
|
2 participants
n=49 Participants
|
4 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
49 Participants
n=49 Participants
|
99 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=99 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
language
English
|
50 participants
n=50 Participants
|
43 participants
n=49 Participants
|
93 participants
n=99 Participants
|
|
language
French
|
0 participants
n=50 Participants
|
6 participants
n=49 Participants
|
49 participants
n=99 Participants
|
|
highest level of education completed
Completed high school
|
4 Participants
n=50 Participants
|
4 Participants
n=49 Participants
|
8 Participants
n=99 Participants
|
|
highest level of education completed
Vocational / technical training (post high school)
|
13 Participants
n=50 Participants
|
13 Participants
n=49 Participants
|
26 Participants
n=99 Participants
|
|
highest level of education completed
Some university training
|
5 Participants
n=50 Participants
|
4 Participants
n=49 Participants
|
9 Participants
n=99 Participants
|
|
highest level of education completed
Completed university
|
28 Participants
n=50 Participants
|
28 Participants
n=49 Participants
|
56 Participants
n=99 Participants
|
|
combined household income
Under $30,000
|
4 Participants
n=50 Participants
|
7 Participants
n=49 Participants
|
11 Participants
n=99 Participants
|
|
combined household income
$30,000 - $69,000
|
8 Participants
n=50 Participants
|
9 Participants
n=49 Participants
|
17 Participants
n=99 Participants
|
|
combined household income
$70,000 - $100,000
|
10 Participants
n=50 Participants
|
12 Participants
n=49 Participants
|
22 Participants
n=99 Participants
|
|
combined household income
Above $100,000
|
21 Participants
n=50 Participants
|
18 Participants
n=49 Participants
|
39 Participants
n=99 Participants
|
|
combined household income
Declined to answer
|
6 Participants
n=50 Participants
|
2 Participants
n=49 Participants
|
8 Participants
n=99 Participants
|
|
mother smokes at home
|
1 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=99 Participants
|
|
marital status
marries / common-law
|
45 Participants
n=50 Participants
|
47 Participants
n=49 Participants
|
92 Participants
n=99 Participants
|
|
marital status
single
|
5 Participants
n=50 Participants
|
1 Participants
n=49 Participants
|
6 Participants
n=99 Participants
|
|
marital status
unknown
|
0 Participants
n=50 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=99 Participants
|
|
number of prior children
none
|
22 Participants
n=50 Participants
|
31 Participants
n=49 Participants
|
53 Participants
n=99 Participants
|
|
number of prior children
1
|
22 Participants
n=50 Participants
|
14 Participants
n=49 Participants
|
36 Participants
n=99 Participants
|
|
number of prior children
>1
|
6 Participants
n=50 Participants
|
8 Participants
n=49 Participants
|
14 Participants
n=99 Participants
|
|
number of prior breastfed children
0
|
24 Participants
n=50 Participants
|
31 Participants
n=49 Participants
|
55 Participants
n=99 Participants
|
|
number of prior breastfed children
1
|
23 Participants
n=50 Participants
|
15 Participants
n=49 Participants
|
38 Participants
n=99 Participants
|
|
number of prior breastfed children
>1
|
3 Participants
n=50 Participants
|
3 Participants
n=49 Participants
|
6 Participants
n=99 Participants
|
|
received breastfeeding support with prior infants
|
14 Participants
n=50 Participants
|
15 Participants
n=49 Participants
|
29 Participants
n=99 Participants
|
|
infant received formula prior to hospitalization
|
27 Participants
n=50 Participants
|
22 Participants
n=49 Participants
|
49 Participants
n=99 Participants
|
|
received medical care from:
obstetrician
|
32 participants
n=50 Participants
|
29 participants
n=49 Participants
|
61 participants
n=99 Participants
|
|
received medical care from:
family physician
|
29 participants
n=50 Participants
|
21 participants
n=49 Participants
|
50 participants
n=99 Participants
|
|
received medical care from:
midwife
|
8 participants
n=50 Participants
|
15 participants
n=49 Participants
|
23 participants
n=99 Participants
|
|
received medical care from:
no prenatal care
|
3 participants
n=50 Participants
|
0 participants
n=49 Participants
|
3 participants
n=99 Participants
|
|
attended prenatal classes
|
17 Participants
n=50 Participants
|
21 Participants
n=49 Participants
|
38 Participants
n=99 Participants
|
|
planning to return to work before child is 1 year of age
|
10 Participants
n=50 Participants
|
12 Participants
n=49 Participants
|
22 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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
Exclusive breastfeeding was defined as no milk intake other than breast milk
Outcome measures
| Measure |
Lactation Consultant
n=45 Participants
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.
|
Current Treatment for Jaundice
n=41 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
Exclusive breastfeeding was defined as no milk intake other than breast milk
Outcome measures
| Measure |
Lactation Consultant
n=44 Participants
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.
|
Current Treatment for Jaundice
n=38 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPartial breastfeeding was defined as any feeding of breast milk
Outcome measures
| Measure |
Lactation Consultant
n=45 Participants
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.
|
Current Treatment for Jaundice
n=41 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely
|
43 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
Partial breastfeeding was defined as any amount of feeding breast milk
Outcome measures
| Measure |
Lactation Consultant
n=44 Participants
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.
|
Current Treatment for Jaundice
n=38 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Participants Partially Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely
|
37 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Lactation Consultant
n=50 Participants
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.
|
Current Treatment for Jaundice
n=49 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Participants With an Infant Re-hospitalized for Jaundice
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Lactation Consultant
n=50 Participants
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.
|
Current Treatment for Jaundice
n=49 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Participants With an Infant Re-hospitalized for Non-jaundice Related Causes in the First Six Months of Life
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Lactation Consultant
n=50 Participants
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.
|
Current Treatment for Jaundice
n=49 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Physician Encounters in First 6 Months of Life
|
9.2 physician encounters
Interval 6.0 to 12.0
|
9.9 physician encounters
Interval 6.3 to 12.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
Outcome measures
| Measure |
Lactation Consultant
n=44 Participants
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.
|
Current Treatment for Jaundice
n=38 Participants
Babies will receive current standard of care for jaundice (IV fluids and phototherapy)
|
|---|---|---|
|
Number of Mothers Seeking Breastfeeding Help
|
11 Participants
|
7 Participants
|
Adverse Events
Lactation Consultant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Current Treatment for Jaundice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Catherine Pound
Children's Hospital of Eastern Ontario
Phone: 613-737-7600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place