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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00298584
First received: February 28, 2006
Last updated: February 22, 2007
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Pain
Intensive Care, Neonatal
Procedure: Percutaneous Suprapubic Aspiration
Procedure: Urethral Catheterization
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection for Diagnosis of Infection: Suprapubic Aspiration and Urinary Catheterization

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298584

Contacts
Contact: Anna Taddio, PhD 416-813-6235 anna.taddio@sickkids.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Vibhuti Shah, MD    416-586-4800 ext 4816    vshah@mtsinai.on.ca   
Principal Investigator: Vibhuti Shah, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Anna Taddio, PhD    416-813-6235    anna.taddio@sickkids.ca   
Principal Investigator: Anna Taddio, PhD         
Sub-Investigator: Patrick McNamara, MD         
Sub-Investigator: Walid El Naggar, MD         
Sub-Investigator: Jennifer Manley, BA         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00298584     History of Changes
Other Study ID Numbers: 1000008396
Study First Received: February 28, 2006
Last Updated: February 22, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Diagnostic techniques, urological
urinary catheterization
Aspiration
Neonates
Neonatal Intensive Care Unit
Infant, Newborn
Infant, Premature
Infant, Low-birth weight

ClinicalTrials.gov processed this record on November 25, 2014