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Urine Collection Methods for Infant Pain Management

Phase 3
Waitlist Available
Led By Anna Taddio, PhD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare two ways of collecting urine to see which is less painful and has fewer complications.

Who is the study for?
This trial is for infants in the NICU who need urine tests. It's not for those with bleeding disorders, on painkillers or sedatives, with neurological issues, certain birth defects, colostomy, enlarged organs, hernia, swollen belly or infections there, or diagnosed with birth asphyxia or seizures.Check my eligibility
What is being tested?
The study compares two ways to get urine from babies: a needle through the tummy (SPA) and a tube into the bladder (UC). It looks at which hurts less and checks success and complication rates of both methods.See study design
What are the potential side effects?
Possible side effects include discomfort during collection and potential complications like infection at the site where urine is collected. The exact side effects will depend on which method is used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
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 obtaining a sample suitable for analysis
success rate of procedure according to infant factors; gestational age and sex

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
683 Previous Clinical Trials
6,944,956 Total Patients Enrolled
Anna Taddio, PhDPrincipal InvestigatorThe Hospital for Sick Children, Toronto Canada
16 Previous Clinical Trials
18,630 Total Patients Enrolled

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT00298584 — Phase 3
Neonatal Intensive Care Unit (NICU) Research Study Groups:
Neonatal Intensive Care Unit (NICU) Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT00298584 — Phase 3
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT00298584 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults the only age group welcome to participate in this research?

"This study includes infants that are as young as one day old, and no older than six months old."

Answered by AI

Is there a high risk of serious side effects for people who undergo this treatment?

"The safety of this treatment is estimated to be a 3. This is due to the fact that this is a Phase 3 trial, which suggests that not only is there some data supporting efficacy, but also multiple rounds of data supporting safety."

Answered by AI

Are there any open positions for this clinical trial?

"This particular trial is not recruiting patients currently, as noted on clinicaltrials.gov. This study was originally posted on February 1st, 2006 and was last updated on February 22nd, 2007. There are, however, other trials 366 other studies that are actively recruiting."

Answered by AI
~3 spots leftby Mar 2025