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

November 10, 2022 updated by: Nihan Korkmaz, Istanbul University - Cerrahpasa (IUC)

The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urinary Tract Infection (UTI) is common in early childhood. Urinary Tract Infection (UTI) is the most common bacterial infection in febrile children younger than 3 months of age (Korbel et al., 2017; Velasco et al., 2015). A clean urine sample is required to diagnose various diseases, especially urinary tract infections (UTI) in infants. 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).

One of the non-invasive methods used to collect urine samples is the use of sterile urine collection bags (Herreros Fernández et al., 2013). This method is not an effective method due to its high false positive rate, time consuming, delayed treatment, skin irritation and high risk of contamination (Finnell et al., 2011; Kaufman et al., 2020). Therefore, sterile urine bags should be used in urinalysis instead of urine culture (Balighian & Review, 2018). Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI. However, this method is possible for children with sphincter control (Altuntas et al., 2015; Kaufman et al., 2019).

A technique was recently described that allows midstream urine specimen collection in children without sphincter control. The technique, consisting of bladder stimulation and lumbar paravertebral massage, was successful in 86% of newborns, with an average duration of 57 seconds (Herreros Fernández et al., 2013). Previous studies have evaluated the technique's success rate and processing time (Altuntas et al., 2015, Labrosse et al., 2016, Crombie et al., 2020), contamination rate (Herreros et al., 2021), and cost (Kaufman et al., 2020) examined. Examination of the effect of the technique on the comfort and physiological parameters of the newborn will contribute to more information about the technique.

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.

Study Population and Sampling The population of the research will be the newborns followed in the neonatal intensive care unit. The sample will consist of 64 (Experimental group = 32, Control group = 32) newborns who meet the inclusion criteria of the study. In calculating the sample size, Altuntaş et al. (2015) benefited from the study. Considering the success rates; The minimum number of samples to be taken was determined as 64 (Experimental group=32, Control group=32) with 95% confidence (1-α), 95% test power (1-β), w=0.453 effect size.

Randomization Infants meeting the research inclusion criteria will be divided into experimental and control groups using a computer-based program (https://www.randomizer.org).

Data Collection Method: The data will be collected by the a researcher in the unit where the study is planned to be carried out.

  • Data Collection Form: Prepared by the researcher. The form includes questions about the infant's age, weight, gender, fever, heartbeat, saturation level, Comfortneo scale score, and procedure success and duration of the procedure.
  • Comfortneo scale: Developed by Ambuel et al. (Ambuel et.al. 1992). Van Dijk et al. revised the COMFORTneo scale to measure behavior in newborns without physiological parameters (Van Dijk et. al. 2009). Turkish validity and reliability of the scale Kahraman et al. (Kahraman et. al 2014). The scale consists of 7 items: muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying. "Respiratory response" is scored in infants on mechanical ventilator, and "crying" is scored in spontaneously breathing infants. A total score is calculated over 6 items. The lowest score that can be obtained from this scale is 6, and the highest score is 30. A high score indicates that the baby is not comfortable and needs interventions to provide comfort (Kahraman et. al 2014).
  • Pulse Oximeter Device to detect infants' oxygen saturation (SPO2) and heart rate (HR)
  • Weighing Tool to determine the current weight of babies.
  • Thermometer to determine babies' body temperature

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Şişli, İstanbul, Turkey, 34360
        • Nihan Korkmaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full-term newborns aged 3-28 days
  • Collecting urine specimen
  • Being fed orally
  • Having written consent from parents

Exclusion Criteria:

  • Poor general clinical condition (respiratory distress, etc.)
  • Poor feding
  • Dehydration
  • Oliguria/anuria
  • Treatment with nephrotoxic drugs
  • Serious illnesses affecting the mobility of the baby
  • Having neurological and anatomical anomalies that may affect bladder function Any condition (meningocele, meningomyelocele etc.) that will prevent the implementation of the stimulation maneuver

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental Group
  • Newborns will be fed with formula or breast milk pumped, according to the age and weight of the baby.
  • Before the procedure, the newborn's heart rate, saturation and comfort scale score will be recorded.
  • Genital area will be cleaned.
  • Newborn will be held under the armpit by a nurse, baby boys will be held with their legs hanging down, and baby girls will be held in hip flexion position.
  • Newborn with spontaneous voiding during the period from the beginning of the research procedure until the newborn is positioned will be excluded from the study.
  • The bladder stimulation technique will be repeated sequentially for 3 minutes until micturition begins.
  • After the maneuvers are started, the newborn's heart rate and saturation comfort scale score will be recorded at the 1st and 3rd minutes.
  • The success of the procedure and the duration of the procedure will be recorded
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.
ACTIVE_COMPARATOR: Control Group
  • Newborns will be fed with formula or breast milk pumped, according to the age and weight of the baby.
  • Before the procedure, the newborn's heart rate, saturation and comfort scale score will be recorded.
  • Genital area will be cleaned.
  • Newborns will be fitted with a sterile urine bag suitable for their gender.
  • Babies who urinate spontaneously during the period until the sterile urine bag is fitted, the next feeding hour will be waited.
  • Newborn will be observed for 3 minutes. Newborn's heart rate and saturation comfort pain scale score will be recorded at the 1st and 3rd minutes.
  • The success of the procedure and the duration of the procedure will be recorded
Procedure: Steril urine bag
Steril urine bag are attached to the genital area to collect urine samples
Other Names:
  • Sterile urine bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: During the procedure (3 minutes)
Procedural success is defined as urine sample collection within 3 minutes (180 seconds) of starting the stimulation maneuvers.
During the procedure (3 minutes)
Duration of the procedure
Time Frame: During the procedure (3 minutes)
Duration of the procedure is defined as the time from the beginning of bladder stimulation to the beginning of micturition
During the procedure (3 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: Before the procedure, at the 1st and 3rd minutes]
The comfort levels of the newborns during the procedure will determined by the researcher.
Before the procedure, at the 1st and 3rd minutes]
Heart rate
Time Frame: Before the procedure, at the 1st and 3rd minutes]
The heart rate of the infants will measured with hand portable pulse oximeter
Before the procedure, at the 1st and 3rd minutes]
Peripheral oxygen saturation level
Time Frame: Before the procedure, at the 1st and 3rd minutes]
The peripheral oxygen saturation levels of the infants will measured with hand portable pulse oximeter
Before the procedure, at the 1st and 3rd minutes]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Birsen Mutlu, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Fatma Narter Kaya, Kartal Dr. Lutfi Kirdar City Hospital
  • Principal Investigator: Nihan Korkmaz, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Kadriye Şahin, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Hande Özgürü, Kartal Dr. Lutfi Kirdar City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2021

Primary Completion (ACTUAL)

September 1, 2022

Study Completion (ACTUAL)

November 1, 2022

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (ACTUAL)

June 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nihan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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