The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns

NCT05416736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-11-14

No results posted yet for this study

Summary

Urine specimen are necessary to diagnose various diseases in infants, especially urinary tract infections (UTI). Various non-invasive and invasive clinical interventions have been described for urine specimen collection. These; suprapubic aspiration, urinary catheterization, sterile urine collection bag and clean-caught urine (Herreros Fernández et al., 2013). For the diagnosis of UTI, it is recommended to collect urine samples by suprapubic aspiration (SPA) and urinary catheterization methods. However, these techniques are invasive and painful (Roberts et al. 2016). Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI. But this method is possible for children with sphincter control. A technique was recently described that allows midstream urine specimen collection in children without sphincter control. This technique consists of bladder stimulation and lumbar paravertebral massage. The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success, procedure time, physiological parameters and comfort in urine specimen collection in newborns.

Conditions

  • Urine Specimen Collection

Interventions

PROCEDURE

The bladder stimulation technique

The bladder stimulation technique consists of two consecutive maneuvers. In the first maneuver, the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, circular massage is applied to the paravertebral region for 30 seconds. The two stimulation maneuvers will be repeated alternately for 3 minutes (180 seconds) until micturition begins. Maneuvers will be performed by the researcher. Infants in both groups will be held under the armpit by a parent, male infants will be held in the drooping legs, and female infants will be held in the hip flexion position.

PROCEDURE

Steril urine bag

Steril urine bag are attached to the genital area to collect urine samples

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Fatma Narter Kaya · Kartal Dr. Lütfi Kirdar City Hospital

  • Birsen Mutlu · Istanbul University - Cerrahpasa

  • Nihan Korkmaz · Istanbul University - Cerrahpasa

  • Kadriye Şahin · Istanbul University - Cerrahpasa

  • Hande Özgürü · Kartal Dr. Lütfi Kirdar City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-09-01
Completion
2022-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416736 on ClinicalTrials.gov