Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000074695
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
5/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a 24% sucrose solution (used for procedural pain relief) have similar analgesic properties when given to infants of substance abusing mothers, compared to matched healthy infants
Scientific title
Does a 24% sucrose solution (used for procedural pain relief) have similar analgesic properties when given to infants of substance abusing mothers, compared to matched healthy infants
Universal Trial Number (UTN)
Trial acronym
Does sucrose act differently i
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural pain 149 0
Condition category
Condition code
Alternative and Complementary Medicine 168 168 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to show that sucrose has a similar analgesic effect, when given to an infant born to a substance dependent mother, compared to a healthy matched infant. The secondary aim of this study is to objectively assess the effectiveness of sucrose with a modified pain assessment tool.
Prospective cohort study. 26 healthy term infants (control) vs 26 Infants of substance abuse mothers.
Compare the two groups response to a "heel stick" blood sample for the NSW Newborn Screening test, when both groups have been given 0.05ml of a 24 % sucrose solution (orally) throughout the procedure every 1-2 minutes.
Intervention code [1] 96 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 207 0
Modified pain assessment tool, that rates a pain response on assessment of the infants facial expression, body movement and oxygen saturation and heart rate.
Timepoint [1] 207 0
Measurements at 2 minutes before the heelstick (baseline), during the heel stick and 2 minutes after the heelstick.
Secondary outcome [1] 473 0
There is no further monitoring required after the completion of the study.
Timepoint [1] 473 0

Eligibility
Key inclusion criteria
Written infarmed consent for the NSW Newborn screening test as well as the research study. All infants must be greater than 37 weeks completed gestation.
Minimum age
37 Weeks
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Symptoms of respiratory distress, problems with glucose metabolism, feed intolerance or necrotising entero-colitis, congenital anomalies, grade three or grade four intraventricular haemorrhages.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 223 0
Self funded/Unfunded
Name [1] 223 0
Country [1] 223 0
Primary sponsor type
Individual
Name
James Rodney Marceau
Address
Country
Secondary sponsor category [1] 166 0
None
Name [1] 166 0
NIL
Address [1] 166 0
Country [1] 166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1023 0
Sydney West Area Health Service
Ethics committee address [1] 1023 0
Ethics committee country [1] 1023 0
Australia
Date submitted for ethics approval [1] 1023 0
Approval date [1] 1023 0
Ethics approval number [1] 1023 0
Ethics committee name [2] 1024 0
Human Research Ethics Committee
Ethics committee address [2] 1024 0
Ethics committee country [2] 1024 0
Australia
Date submitted for ethics approval [2] 1024 0
Approval date [2] 1024 0
Ethics approval number [2] 1024 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36176 0
Address 36176 0
Country 36176 0
Phone 36176 0
Fax 36176 0
Email 36176 0
Contact person for public queries
Name 9285 0
James Rodney Marceau
Address 9285 0
30 Glenell St
Blaxland NSW 2774
Country 9285 0
Australia
Phone 9285 0
+61 2 47392303
Fax 9285 0
Email 9285 0
[email protected]
Contact person for scientific queries
Name 213 0
James Rodney Marceau
Address 213 0
30 Glenell St
Blaxland NSW 2774
Country 213 0
Australia
Phone 213 0
+61 2 47392303
Fax 213 0
Email 213 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.