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

NCT05416736 | Completed

• 1 other identifier: Nihan
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Urine Specimen Collection

Keywords

urine specimen; bladder stimulation technique; newborn; comfort; physiological parameters

Outcome Measures

Primary Outcomes (2)

• Procedural success

  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

  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 Outcomes (3)

• Comfort

  Before the procedure, at the 1st and 3rd minutes]

• Heart rate

  Before the procedure, at the 1st and 3rd minutes]

• Peripheral oxygen saturation level

  Before the procedure, at the 1st and 3rd minutes]

Study Arms (2)

Experimental Group

EXPERIMENTAL

* 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

Control Group

ACTIVE COMPARATOR

* 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

Interventions

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.

Experimental Group

Steril urine bag PROCEDURE

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

Also known as: Sterile urine bag

Control Group

Eligibility Criteria

• Age: 3 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Nihan Korkmaz

Şişli, Istanbul, 34360, Turkey (Türkiye)

Location

Related Publications (15)

• Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.

  PMID: 23172785 BACKGROUND

• Korbel L, Howell M, Spencer JD. The clinical diagnosis and management of urinary tract infections in children and adolescents. Paediatr Int Child Health. 2017 Nov;37(4):273-279. doi: 10.1080/20469047.2017.1382046. Epub 2017 Oct 5.

  PMID: 28978286 BACKGROUND

• Velasco R, Benito H, Mozun R, Trujillo JE, Merino PA, Mintegi S; Group for the Study of Febrile Infant of the RISeuP-SPERG Network. Febrile young infants with altered urinalysis at low risk for invasive bacterial infection. a Spanish Pediatric Emergency Research Network's Study. Pediatr Infect Dis J. 2015 Jan;34(1):17-21. doi: 10.1097/INF.0000000000000482.

  PMID: 25036049 BACKGROUND

• SUBCOMMITTEE ON URINARY TRACT INFECTION. Reaffirmation of AAP Clinical Practice Guideline: The Diagnosis and Management of the Initial Urinary Tract Infection in Febrile Infants and Young Children 2-24 Months of Age. Pediatrics. 2016 Dec;138(6):e20163026. doi: 10.1542/peds.2016-3026. No abstract available.

  PMID: 27940735 BACKGROUND

• Finnell SM, Carroll AE, Downs SM; Subcommittee on Urinary Tract Infection. Technical report-Diagnosis and management of an initial UTI in febrile infants and young children. Pediatrics. 2011 Sep;128(3):e749-70. doi: 10.1542/peds.2011-1332. Epub 2011 Aug 28.

  PMID: 21873694 BACKGROUND

• Kaufman J. How to... collect urine samples from young children. Arch Dis Child Educ Pract Ed. 2020 Jun;105(3):164-171. doi: 10.1136/archdischild-2019-317237. Epub 2019 Aug 23.

  PMID: 31444213 BACKGROUND

• Balighian E, Burke M. Urinary Tract Infections in Children. Pediatr Rev. 2018 Jan;39(1):3-12. doi: 10.1542/pir.2017-0007. No abstract available.

  PMID: 29292282 BACKGROUND

• Altuntas N, Tayfur AC, Kocak M, Razi HC, Akkurt S. Midstream clean-catch urine collection in newborns: a randomized controlled study. Eur J Pediatr. 2015 May;174(5):577-82. doi: 10.1007/s00431-014-2434-z. Epub 2014 Oct 17.

  PMID: 25319844 BACKGROUND

• Labrosse M, Levy A, Autmizguine J, Gravel J. Evaluation of a New Strategy for Clean-Catch Urine in Infants. Pediatrics. 2016 Sep;138(3):e20160573. doi: 10.1542/peds.2016-0573. Epub 2016 Aug 19.

  PMID: 27542848 BACKGROUND

• Crombie T, Slinger R, Barrowman NJ, McGahern C, Smith L, Chu J, McCoy K, Akiki S, Agarwal A, Plint AC. Pragmatic evaluation of a midstream urine collection technique for infants in the emergency department. CJEM. 2020 Sep;22(5):665-672. doi: 10.1017/cem.2020.31.

  PMID: 32383423 BACKGROUND

• Herreros ML, Gili P, Del Valle R, Barrios A, Pacheco M, Sanchez A. Urine collection methods for infants under 3 months of age in clinical practice. Pediatr Nephrol. 2021 Dec;36(12):3899-3904. doi: 10.1007/s00467-021-05142-4. Epub 2021 Jun 7.

  PMID: 34100109 BACKGROUND

• Kaufman J, Knight AJ, Bryant PA, Babl FE, Dalziel K. Liquid gold: the cost-effectiveness of urine sample collection methods for young precontinent children. Arch Dis Child. 2020 Mar;105(3):253-259. doi: 10.1136/archdischild-2019-317561. Epub 2019 Aug 23.

  PMID: 31444211 BACKGROUND

• Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95.

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• van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.

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• Kahraman A, Başbakkal Z, Yalaz M. Turkish Validity And Reliability Of Comfortneo Scale. International Refereed Journal of Nursing Research. 2014; 1: 1-11

  BACKGROUND

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 13, 2022
• Study Start: October 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

TU (1)