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Pain in two methods of sterile urine collection in neonates

Comparison of Pain in suprapubic aspiration and transurethral catheterization two methods of sterile urine collection in neonates: A Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT138812183512N1
Enrollment
90
Registered
2012-02-12
Start date
2011-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatal urinary tract infection. neonatal urinary tract infection

Interventions

Intervention 1: In the intervention group transurethral catheterization is performed in patients who require urine culture in a sterile and standard manner.The neonates are monitored in the NICU for h
Diagnosis
In the intervention group transurethral catheterization is performed in patients who require urine culture in a sterile and standard manner.The neonates are monitored in the NICU for heart rate & oxyg
In the cotrol group suprapubic aspiration is performed in patients who require urine culture in a sterile and standard manner.The neonates are monitored in the NICU for heart rate & oxygen saturation

Sponsors

Mazandaran University of Medical Siences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: In this study we include infants ,0-2 months of age ,of both sexes , admitted to NICU or neonatal ward of Bu-Ali hospital who need a urine sample for microbiological studies. The exclusion criteria were the clinical diagnosis of seizure, asphyxia, decreased level of consciousness, congenital anomalies in central nervous system, genitourinary and gastrointestinal tracts, presence of abdominal distention, abdominal wall cellulites, colostomy, inguinal hernia, organomegaly, any hemorrhagic disorder and the patients who had received sedative or hypnotic drugs.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Feeling of pain in the neonate. Timepoint: from 30 seconds of starting the procedures, during it and till 30 seconds after the end of the procedures. Method of measurement: Premature Infant Pain Profile scale.

Secondary

MeasureTime frame
The success rates in urine sampling. Timepoint: after sampling. Method of measurement: obtaining 2 ml. of urine for analysis.;Duration of procedures. Timepoint: during the procedures. Method of measurement: with a stop watch in seconds.;Contamination rate of urine sample. Timepoint: 48-72 hour after sampling. Method of measurement: urine culture.;Adverse events. Timepoint: till 2 weeks after procedures. Method of measurement: physical exam for : abdominal wall abscess, hematuria , peritonitis ,intestinal perforation,hemmorhage, bladder perforation, hematoma,.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Nakhshab

Mazandaran University of Medical Siences

mnakhshab@mazums.ac.ir pegahch@yahoo.com+98 15 1321 0853

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026