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Trial registered on ANZCTR


Registration number
ACTRN12609000712202
Ethics application status
Approved
Date submitted
13/08/2009
Date registered
18/08/2009
Date last updated
8/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preterm Infant receiving Breast Milk or Glucose for Pain Relief Study (PIMiG Pain Study): a randomised controlled trial.
Scientific title
Preterm Infant receiving Breast Milk or Glucose for Pain Relief Study (PIMiG Pain Study)
Secondary ID [1] 252184 0
New secondary ID. Please modify.
Secondary ID [2] 263004 0
Breast milk and glucose for pain relief in preterm infants: a noninferiority randomized controlled trial
Universal Trial Number (UTN)
Trial acronym
PIMiG Pain Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain in neonates related to heel lancing 243517 0
Condition category
Condition code
Alternative and Complementary Medicine 239814 239814 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Orally administered expressed breast milk (volume: 2ml), prior to a single heel lance. Heel lance will be performed by using a mechanical device in which a stylet is placed in the spring-loaded cartridge. It takes less than 30 seconds to perform the puncture and blood collection.
Intervention code [1] 241130 0
Treatment: Other
Comparator / control treatment
Orally administered 25% glucose solution (volume: 2ml), prior to a single heel lance
Control group
Active

Outcomes
Primary outcome [1] 240576 0
Premature Infant Pain Profile scores
Timepoint [1] 240576 0
30 seconds after the painful procedure
Secondary outcome [1] 257209 0
Heart rate (measured by an electrocardiogram (ECG) monitor)
Timepoint [1] 257209 0
Baseline (15 seconds before the procedure)
After the painful procedure (each 30 seconds after the procedure, during 3 minutes)

Eligibility
Key inclusion criteria
Near term neonates
Minimum age
12 Hours
Maximum age
72 Hours
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Oral fasting, alteration of swallow or gag reflexes, assisted ventilation, born to mothers who have human immunodeficiency virus (HIV) and/or C hepatitis, born to mothers users of illicit drugs, proven or suspected intracranial hemorrhage grade II or more, neonates who underwent surgery, use of analgesic or sedatives for less than 24 hours before the procedure, proven or suspected necrotizing enterocolitis

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)
Allocation concealment was achieved by using numbered opaque sealed envelopes containing intervention codes. Envelopes were exclusively accessed by research assistants and contained intervention codes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician used the Statistical Analysis System (SAS), version 8.2 to generate blocked randomization lists. Randomization was stratified according to infants’ type of feeding (e.g., breast feeding and artificial milk). Rationale for stratification was because of the published effects of breast feeding as an analgesic method for neonatal procedural pain.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Noninferiority randomised controlled trial.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1952 0
Brazil
State/province [1] 1952 0

Funding & Sponsors
Funding source category [1] 237498 0
Government body
Name [1] 237498 0
The State of Sao Paulo Research Foundation (FAPESP)
Address [1] 237498 0
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP - Brasil
Country [1] 237498 0
Brazil
Primary sponsor type
Government body
Name
The State of Sao Paulo Research Foundation (FAPESP)
Address
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP - Brasil
Country
Brazil
Secondary sponsor category [1] 236980 0
None
Name [1] 236980 0
Address [1] 236980 0
Country [1] 236980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271779 0
Comissao de Etica para Analise de Projetos de Pesquisa do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Ethics committee address [1] 271779 0
Rua Dr. Ovidio Pires de Campos, 225
Cerqueira Cesar - Sao Paulo/SP
05403-010
Ethics committee country [1] 271779 0
Brazil
Date submitted for ethics approval [1] 271779 0
01/04/2008
Approval date [1] 271779 0
18/07/2008
Ethics approval number [1] 271779 0
404/08

Summary
Brief summary
The aim of the study is to compare the use of expressed breast milk and 25% glucose as analgesic strategies for pain relief in preterm neonates. The hypothesis is that breast milk is as effective as glucose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30049 0
Address 30049 0
Country 30049 0
Phone 30049 0
Fax 30049 0
Email 30049 0
Contact person for public queries
Name 13296 0
Mariana Bueno
Address 13296 0
Rua Itapiru, 224, apto 31
Saude
Sao Paulo, SP, Brazil
04143-010
Country 13296 0
Brazil
Phone 13296 0
55 11 91367136
Fax 13296 0
Email 13296 0
mariana.bueno@usp.br
Contact person for scientific queries
Name 4224 0
Mariana Bueno
Address 4224 0
Rua Itapiru, 224, apto 31
Saude
Sao Paulo, SP, Brazil
04143-010
Country 4224 0
Brazil
Phone 4224 0
55 11 91367136
Fax 4224 0
Email 4224 0
mariana.bueno@usp.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary