Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000164695
Ethics application status
Approved
Date submitted
5/02/2014
Date registered
11/02/2014
Date last updated
11/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of oral sucrose in newborns exposed to painful stimuli
Scientific title
Efficacy of 24% oral sucrose in the prevention and treatment of pain in Neonatal Intensive Care Unit
Secondary ID [1] 284026 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain
 291072 0
Condition category
Condition code
Anaesthesiology 291414 291414 0 0
Pain management
Reproductive Health and Childbirth 291456 291456 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: 24% sucrose oral solution was administered during capillary and arterial blood sample taking, directly by a disposable plastic vial at dosage of 1.5 ml for newborns with more than 3 kg and 1 ml for newborns with a birth weight less than 3 kg
Intervention code [1] 288716 0
Treatment: Other
Intervention code [2] 288749 0
Prevention
Comparator / control treatment
Arm 2: sterile water was administered directly by a disposable plastic vial during capillary and arterial blood sample taking
Control group
Placebo

Outcomes
Primary outcome [1] 291406 0
Effects of 24% sucrose solution and non nutritive sucking on pain perception during capillary and arterial blood sample taking.
Skin conductance algesimeters was used to monitor pain.
Timepoint [1] 291406 0
Skin conductance activity was measured for 3 min before, during, and for 3 min after the intervention.
Secondary outcome [1] 306691 0
To assess how preterm newborn infants react to potential painful and how this response changes with different postnatal age
Timepoint [1] 306691 0
Skin conductance activity was measured for 3 min before, during, and for 3 min after the intervention. Heart rate, respiratory rate, oxygen saturation were assessed by pulse oximetry during the procedure.

Eligibility
Key inclusion criteria
All infants admitted to the Unit of Neonatal Intensive Care of Monaldi Hospital, Naples, Italy.
Minimum age
No limit
Maximum age
1 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Newborns receiving muscle relaxants and those with impaired skin integrity, which precluded applying additional tape or monitoring devices to the skin.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers were used to assign patients to the two treatment arms
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data were collected in a specific designed database and analysed with statistical analysis performed employing the Software Package for the Social Sciences (SPSS for Windows, version 15.0, SPSS Inc, Chicago, Ill). The Pearson chi square test was used to evaluate the difference in prevalences. A Kruskal–Wallis test was used to assess differences between means and inter-group comparisons. Correlations were determined by Pearson correlation. A p-value of < 0.01 was considered statistically significant.
We estimated a sample size of 56 patients, based on the following assumptions: (1) a two-sided t-student test of statistical significance, (3) a probability of type I error associated with the two-sided test of 0.01 and (4) a probability of type II error associated with the test of 0.2 (ie, the power of the test is 80%).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2013
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
31/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 5804 0
Italy
State/province [1] 5804 0

Funding & Sponsors
Funding source category [1] 288663 0
Hospital
Name [1] 288663 0
Monaldi Hospital
Country [1] 288663 0
Italy
Primary sponsor type
Hospital
Name
Monaldi Hospital
Address
Via Leonardo Bianchi- 80131- Naples
Country
Italy
Secondary sponsor category [1] 287371 0
None
Name [1] 287371 0
Address [1] 287371 0
Country [1] 287371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290513 0
Comitato Etico Monaldi
Ethics committee address [1] 290513 0
Via Leonardo Bianchi – 80131 Naples
Ethics committee country [1] 290513 0
Italy
Date submitted for ethics approval [1] 290513 0
08/04/2013
Approval date [1] 290513 0
22/04/2013
Ethics approval number [1] 290513 0
CMSA235AIT06

Summary
Brief summary
This study is aimed to investigate, using skin conductance algesimeters index monitor pain, the effects of 24% sucrose solution and non nutritive sucking on pain perception during capillary and arterial blood sample taking.
Skin conductance algesimeters reflects the sympathetic nervous system influenced by changes in emotions which releases the acetyl choline that acts on muscarine receptors, causing a subsequent burst of sweat and increased skin conductance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45998 0
Dr Annalisa Passariello
Address 45998 0
Via S. Pansini 5-80100-Naples. University of Naples “Federico II”.
Country 45998 0
Italy
Phone 45998 0
+39 3395077349
Fax 45998 0
Email 45998 0
[email protected]
Contact person for public queries
Name 45999 0
Mr Giuseppe Esposito
Address 45999 0
Pzza Vanvitelli 44-80129-Naples. University of Naples “Federico II”.
Country 45999 0
Italy
Phone 45999 0
+39 3333795886
Fax 45999 0
Email 45999 0
[email protected]
Contact person for scientific queries
Name 46000 0
Dr Gianluca Terrin
Address 46000 0
Via di Grotta Rossa 1015/1039 - 00185 Roma. Sapienza University of Rome.
Country 46000 0
Italy
Phone 46000 0
+39 0633774698
Fax 46000 0
Email 46000 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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Documents added automatically
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