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

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05416736

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urine Specimen Collection	Procedure: The bladder stimulation technique Procedure: Steril urine bag	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled experimental designRandomized controlled experimental design

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Procedural success [During the procedure (3 minutes)]
Procedural success is defined as urine sample collection within 3 minutes (180 seconds) of starting the stimulation maneuvers.
Duration of the procedure [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Days to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nihan Korkmaz	Şişli	İstanbul	Turkey	34360

Sponsors and Collaborators

Istanbul University-Cerrahpasa

Investigators

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