Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization

Conditions
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Pain, Intensive Care, Neonatal

Intervention / Treatment
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* Procedure: Percutaneous Suprapubic Aspiration
* Procedure: Urethral Catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis Exclusion Criteria: 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 Organomegaly Bleeding diatheses (thrombocytopenia or coagulopathy) Receiving analgesics or sedatives

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous Suprapubic Aspiration|nan|
|Procedure: Urethral Catheterization|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| success rate of procedure according to infant factors; gestational age and sex |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic techniques, urological, urinary catheterization, Aspiration, Neonates, Neonatal Intensive Care Unit, Infant, Newborn, Infant, Premature, Infant, Low-birth weight