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Trial registered on ANZCTR


Registration number
ACTRN12611000268943
Ethics application status
Not yet submitted
Date submitted
11/02/2011
Date registered
14/03/2011
Date last updated
14/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Breast Milk vs. Sucrose as Analgesia for Painful Procedures in the Neonatal Unit
Scientific title
For babies admitted to our special care baby unit and undergoing one or more painful procedures, is oral breast milk, when compared to sucrose, as good at reducing pain when measured with the Premature Infant Pain Profile.
Secondary ID [1] 253591 0
Nil
Universal Trial Number (UTN)
U1111-1119-4184
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 261146 0
Condition category
Condition code
Anaesthesiology 259303 259303 0 0
Pain management
Reproductive Health and Childbirth 259515 259515 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1ml of oral breast milk given as one dose immediately prior to painful procedures.
Each baby will receive one dose per painful procedure during their admission.
Intervention code [1] 258013 0
Treatment: Other
Intervention code [2] 264208 0
Prevention
Comparator / control treatment
0.2ml of 66% sucrose solution given as one dose orally immediately prior to painful procedures.
Each baby will receive one dose per painful procedure during their admission.
Control group
Active

Outcomes
Primary outcome [1] 262108 0
Pain score, using the Premature Infant Pain Profile.
Timepoint [1] 262108 0
60 seconds from commencement of procedure.
Secondary outcome [1] 273170 0
Successful exclusive breastfeeding on discharge from the neonatal unit, as observed and recorded in the baby's clinical notes.
Timepoint [1] 273170 0
On discharge from the neonatal unit, on average 4 weeks after admission.

Eligibility
Key inclusion criteria
Admission to the Special Care Baby Unit at Waitakere Hospital, and undergoing at least one painful procedure during admission.
Admission criteria to the neonatal unit include prematurity >32 but <36 weeks, weight <2000g, sepsis, hypoglycamia, respiratory distress or clinical instability requiring admission.
Minimum age
No limit
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mother's breast milk not available for administration.
Medically not stable enough to tolerate oral analgesia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Families will be approached early in their baby's stay by the medical or nursing staff in the unit, the study discussed and consent obtained.
When a painful procedure is carried out, a nurse not involved in the care of the child will retrieve a sealed envelope from the drug room to allocate the baby to either breast milk or sucrose. They will then administer the solution without other staff or family being aware of the solution used.
The babies themselves are not blinded because of the difference in taste between sucrose solution and breast milk.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Envelopes will be assigned a random number associated with breast milk or sucrose solution via a spreadsheet.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Each individual baby will receive the same substance for each painful procedure during their stay.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3177 0
New Zealand
State/province [1] 3177 0
Auckland

Funding & Sponsors
Funding source category [1] 258478 0
Self funded/Unfunded
Name [1] 258478 0
Dr Steve Heap
Country [1] 258478 0
New Zealand
Primary sponsor type
Hospital
Name
Waitakere Hospital
Address
Lincoln Road
Henderson
Auckland
0610
Country
New Zealand
Secondary sponsor category [1] 257619 0
None
Name [1] 257619 0
Address [1] 257619 0
Country [1] 257619 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260455 0
Northern X Health and Disability Ethics Committee
Ethics committee address [1] 260455 0
Private Bag 92-522
Wellesley St
Auckland
1141
Ethics committee country [1] 260455 0
New Zealand
Date submitted for ethics approval [1] 260455 0
20/02/2011
Approval date [1] 260455 0
Ethics approval number [1] 260455 0

Summary
Brief summary
Giving babies either a sugar solution or breast milk into their mouth is well known to reduce pain during blood tests or other painful procedures.
No studies have compared the effectiveness of these two methods in the premature babies of a neonatal unit, who unfortunately often have to undergo a number of painful procedures during their stay. Currently in our unit we use both solutions, and this study aims to formally record which babies are receiving which solution and “score” their pain using monitoring of heart rate, oxygen levels, and facial expressions. Each baby will be randomly assigned one of the two solutions, and a nurse who does not know which solution has been given will calculate the pain score during the procedure.
We hope to provide good evidence for both our own and other neonatal units so that we can give the safest, most effective pain relief to our premature babies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32199 0
Address 32199 0
Country 32199 0
Phone 32199 0
Fax 32199 0
Email 32199 0
Contact person for public queries
Name 15446 0
Dr Steve Heap
Address 15446 0
Rangitira Unit
Waitakere Hospital
Lincoln Road
Henderson
Auckland
0610
Country 15446 0
New Zealand
Phone 15446 0
(0064) (9) 839 0000
Fax 15446 0
Email 15446 0
[email protected]
Contact person for scientific queries
Name 6374 0
Dr Steve Heap
Address 6374 0
Rangitira Unit
Waitakere Hospital
Lincoln Road
Henderson
Auckland
0610
Country 6374 0
New Zealand
Phone 6374 0
(0064) (9) 839 0000
Fax 6374 0
Email 6374 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
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