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

NCT00298584 | Unknown Phase 3

• 1 other identifier: 1000008396
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Percutaneous Suprapubic Aspiration PROCEDURE

Urethral Catheterization PROCEDURE

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 20478939 DERIVED

MeSH Terms

Conditions

Pain; Premature Birth

Interventions

Urinary Catheterization

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Anna Taddio, PhD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Taddio, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 2, 2006
• Study Start: February 1, 2006
• Last Updated: February 23, 2007

Record last verified: 2006-08

Locations

CA (2)