PainPhase 3NCT00298584
Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection
A Phase 3 study testing Percutaneous Suprapubic Aspiration and Urethral Catheterization in people with Pain and Intensive Care, Neonatal, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
The purpose of this study is to determine which of the two procedures commonly used to collect urine, percutaneous suprapubic aspiration (SPA) and urethral catheterization (UC), is less painful, and the success rates and complication rates associated with both methods. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Pain, Intensive Care, Neonatal
- What is being tested?
- Percutaneous Suprapubic Aspiration and Urethral Catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis
Who cannot join
- Clinical diagnosis of birth asphyxia or seizures
- Neurological conditions
- Congenital anomalies associated with the central nervous system, gut, or genitourinary tract
- Abdominal distension or abdominal infection/cellulitis
- Colostomy
- Inguinal hernia
Show all 9Show fewer
- Organomegaly
- Bleeding diatheses (thrombocytopenia or coagulopathy)
- Receiving analgesics or sedatives
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Vibhuti Shah, MD, 416-586-4800 ext. 4816, vshah@mtsinai.on.ca
Vibhuti Shah, MD
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Anna Taddio, PhD, 416-813-6235, anna.taddio@sickkids.ca
Anna Taddio, PhD
About this study
Official title: Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization
The purpose of this study is to determine which of the two procedures commonly used to collect urine, percutaneous suprapubic aspiration (SPA) and urethral catheterization (UC), is less painful, and the success rates and complication rates associated with both methods.
Read the detailed description
Infants hospitalized in the NICU undergo numerous invasive and painful procedures. Exposure to early repeated painful procedures has been correlated with both short-term and long-term negative sequelae, such as altered pain responses and increased sensitivity to pain (Taddio 2005). Fifty eligible infants in the NICU will be randomized to undergo urine collection by either suprapubic aspiration (SPA) or urinary catheterization (UC). Outcome measures will include pain, procedure success, and procedure duration. Pain will be measured using facial grimacing (the infant's face will be videotaped for the entire procedure), heart rate and oxygen saturation. Procedure success will be defined by the collection of about 2mL of urine (Falcao, 1999). The procedure duration in seconds for the first attempt will be calculated. Infants will be monitored during the procedure for adverse events such as apnea, bradycardia, desaturation, emesis, increased ventilatory support. Results will be extremely valuable in aiding health care providers to choose a urine collection technique that minimizes the pain and maximizes the success of the procedure.
- Conditions
- Pain, Intensive Care, Neonatal
- Being tested
- Percutaneous Suprapubic Aspiration, Urethral Catheterization
- Keywords
- Diagnostic techniques, urological, urinary catheterization, Aspiration, Neonates, Neonatal Intensive Care Unit, Infant, Newborn, Infant, Premature, Infant, Low-birth weight
- Medical subject headings
- Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Suprapubic AspirationProcedure or surgery
Urethral CatheterizationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
Secondary outcomes (3)
success rate of obtaining a sample suitable for analysis
adverse events, such as post-procedure haematuria, haemorrhage, haematoma, peritonitis, bowel perforation, abdominal wall abscess, and induction of infection, bladder perforation, urethral knots
success rate of procedure according to infant factors; gestational age and sex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Investigators
- Anna Taddio, PhD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298584
- Sponsor's protocol ID
- 1000008396
- Status last verified
- Aug 2006
- First submitted
- 28 Feb 2006
- Last updated
- 23 Feb 2007
- Results posted
- No
Publications
El-Naggar W, Yiu A, Mohamed A, Shah V, Manley J, McNamara P, Taddio A. Comparison of pain during two methods of urine collection in preterm infants. Pediatrics. 2010 Jun;125(6):1224-9. doi: 10.1542/peds.2009-3284. Epub 2010 May 17.
PubMed 20478939
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization
- ClinicalTrials.gov ID
- NCT00298584
- Acronym / sponsor ID
- 1000008396
- Conditions
- Pain, Intensive Care, Neonatal
- Keywords
- Diagnostic techniques, urological, urinary catheterization, Aspiration, Neonates, Neonatal Intensive Care Unit, Infant, Newborn, Infant, Premature, Infant, Low-birth weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Feb 2006
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine which of the two procedures commonly used to collect urine, percutaneous suprapubic aspiration (SPA) and urethral catheterization (UC), is less painful, and the success rates and complication rates associated with both methods.
Detailed description
Infants hospitalized in the NICU undergo numerous invasive and painful procedures. Exposure to early repeated painful procedures has been correlated with both short-term and long-term negative sequelae, such as altered pain responses and increased sensitivity to pain (Taddio 2005). Fifty eligible infants in the NICU will be randomized to undergo urine collection by either suprapubic aspiration (SPA) or urinary catheterization (UC). Outcome measures will include pain, procedure success, and procedure duration. Pain will be measured using facial grimacing (the infant's face will be videotaped for the entire procedure), heart rate and oxygen saturation. Procedure success will be defined by the collection of about 2mL of urine (Falcao, 1999). The procedure duration in seconds for the first attempt will be calculated. Infants will be monitored during the procedure for adverse events such as apnea, bradycardia, desaturation, emesis, increased ventilatory support. Results will be extremely valuable in aiding health care providers to choose a urine collection technique that minimizes the pain and maximizes the success of the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis
Key exclusion criteria (9 listed)
- Clinical diagnosis of birth asphyxia or seizures
- Neurological conditions
- Congenital anomalies associated with the central nervous system, gut, or genitourinary tract
- Abdominal distension or abdominal infection/cellulitis
- Colostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Suprapubic Aspiration | Procedure or surgery | – |
| Urethral Catheterization | Procedure or surgery | – |
Primary outcome
infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
3 secondary outcomes
success rate of obtaining a sample suitable for analysis
adverse events, such as post-procedure haematuria, haemorrhage, haematoma, peritonitis, bowel perforation, abdominal wall abscess, and induction of infection, bladder perforation, urethral knots
success rate of procedure according to infant factors; gestational age and sex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2007.
- Derived from this study: PubMed 20478939El-Naggar W, Yiu A, Mohamed A, Shah V, Manley J, McNamara P, Taddio A. Comparison of pain during two methods of urine collection in preterm infants. Pediatrics. 2010 Jun;125(6):1224-9. doi: 10.1542/peds.2009-3284. Epub 2010 May 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Taddio, PhD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous Suprapubic Aspiration and Urethral Catheterization in people with Pain and Intensive Care, Neonatal, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Taddio, PhD (416-813-6235, anna.taddio@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2007.