Recruiting
Phase 3

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT00298584

Conditions

Pain

Intensive Care, Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Percutaneous Suprapubic Aspiration

Urethral Catheterization

Study Details

Brief 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.

Conditions

Pain

Intensive Care, Neonatal

Study ID

NCT00298584

Start date

Feb, 2006

Status verified date

Aug, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Percutaneous Suprapubic Aspiration

Urethral Catheterization

Primary outcome measure

  • infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Anna Taddio, PhD

416-813-6235anna.taddio@sickkids.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Vibhuti Shah, MD

416-586-4800vshah@mtsinai.on.ca

Principal Investigator:

Vibhuti Shah, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Anna Taddio, PhD

416-813-6235anna.taddio@sickkids.ca

Principal Investigator:

Anna Taddio, PhD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Feb 23, 2007

Last verified

Aug, 2006

Keywords

  • Diagnostic techniques, urological
  • urinary catheterization
  • Aspiration
  • Neonates
  • Neonatal Intensive Care Unit
  • Infant, Newborn
  • Infant, Premature
  • Infant, Low-birth weight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2007-02-23.