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Completed

NCT Number: NCT05416736

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

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.

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Key information

Age range

3 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nihan Korkmaz

Şişli, Istanbul, 34360, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The bladder stimulation technique

Procedure

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.

Steril urine bag

Procedure

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

Other names: Sterile urine bag

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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