Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Suprapubic Aspiration | Procedure | |||
| Urethral Catheterization | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Taddio, PhD | Contact | 416-813-6235 | anna.taddio@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G 1X5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20478939 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
Not provided
Not provided
| ID | Term |
|---|---|
| D014546 | Urinary Catheterization |
| ID | Term |
|---|---|
| D003950 | Diagnostic Techniques, Urological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D002404 | Catheterization |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| success rate of procedure according to infant factors; gestational age and sex |
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |