Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02381834
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2015-03-03
Brief Title:
Evaluation of a Novel Midstream Urine Collection Technique for Infants in the Emergency Department
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
Evaluation of a Novel Midstream Urine Collection Technique for Infants in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinalysis and urine culture are commonly employed laboratory tests in the Emergency Department ED particularly for the purposes of investigating febrile infants in whom bacterial etiologies must be ruled out The standard of care for obtaining sterile urine specimens in this age group remains transurethral bladder catheterization an invasive procedure that is painful and has the potential for causing specimen contamination and iatrogenic urinary tract infection UTI A recent study by Herreros Fernández et al 2013 described a novel bladder stimulation technique for newborns that facilitates midstream urine collection The success rate for this procedure was 863 It remains unknown however as to whether this technique is reproducible amongst infants who present to the ED with a potentially greater severity of illness The primary objective of this study is to determine the success rate of this technique in children 90 days old in the ED
Detailed Description:
Two persons at least one trained nurse RN or physician MD andor one health care aid HCA will be required to perform the procedure one of whom will also measure the time between critical steps of the protocol using a stopwatch The technique involves a combination of fluid administration and non-invasive bladder stimulation manoeuvres that include gently finger tapping the abdomen with or without lower back massage
The first step involves bottle or breastfeeding each infant with an amount of milk that is appropriate for its weight and age Breastfed babies that have no history of poor feeding will be fed ad libitum Those that feed poorly will be encouraged to supplement the feed with either expressed breast milk or formula at the discretion of the parentguardian Formula fed infants will receive a 10 ml feed on the first day of life increasing by 10 ml per day of age to a maximum of 70 ml per feed For infants greater than 7 days old 25 mlkg will be administered per feed Babies that demonstrate mild clinical dehydration andor fail attempts at oral feeding may at the discretion of the most responsible physician MRP have a peripheral intravenous IV catheter placed and receive a fluid bolus of 09 normal saline up to a maximum of 10-20 mlkg given over 20-25 minutes Infants will not be excluded if they do not feed well
Approximately 20 minutes after the feeding or IV fluid bolus the infants genitals will be cleaned in a sterile technique using 005 chlorhexidine Non-pharmacological analgesia as achieved with a soother andor 24 sucrose will be offered to prevent or lessen crying
The second major step of the technique involves holding the infant under the axillae with their legs dangling safely above the crib mattress An RN or MD then begins bladder stimulation by gently finger tapping on the lower abdomen in the midline just above the pubic symphysis at a frequency of 100 taps per minute If this step is unsuccessful after 30 seconds the RNMD will then stimulate the lower back in the lumbar paravertebral zone by lightly massaging the area in a circular motion using both thumbs This too will be performed for a maximum of 30 seconds The two stimulation manoeuvres will be repeated in succession up to a maximum of 5 minutes or 5 cycles until micturition occurs and a midstream urine sample can be caught in a sterile container
Infants who spontaneously urinate after cleaning but prior to bladder stimulation will have their clean catch urine sent to the lab These cases will be considered successful non-invasive attempts
Infants who fail to produce urine will have further feedingfluid administration and bladder catheterization at the discretion of the MRP
The first step involves bottle or breastfeeding each infant with an amount of milk that is appropriate for its weight and age Breastfed babies that have no history of poor feeding will be fed ad libitum Those that feed poorly will be encouraged to supplement the feed with either expressed breast milk or formula at the discretion of the parentguardian Formula fed infants will receive a 10 ml feed on the first day of life increasing by 10 ml per day of age to a maximum of 70 ml per feed For infants greater than 7 days old 25 mlkg will be administered per feed Babies that demonstrate mild clinical dehydration andor fail attempts at oral feeding may at the discretion of the most responsible physician MRP have a peripheral intravenous IV catheter placed and receive a fluid bolus of 09 normal saline up to a maximum of 10-20 mlkg given over 20-25 minutes Infants will not be excluded if they do not feed well
Approximately 20 minutes after the feeding or IV fluid bolus the infants genitals will be cleaned in a sterile technique using 005 chlorhexidine Non-pharmacological analgesia as achieved with a soother andor 24 sucrose will be offered to prevent or lessen crying
The second major step of the technique involves holding the infant under the axillae with their legs dangling safely above the crib mattress An RN or MD then begins bladder stimulation by gently finger tapping on the lower abdomen in the midline just above the pubic symphysis at a frequency of 100 taps per minute If this step is unsuccessful after 30 seconds the RNMD will then stimulate the lower back in the lumbar paravertebral zone by lightly massaging the area in a circular motion using both thumbs This too will be performed for a maximum of 30 seconds The two stimulation manoeuvres will be repeated in succession up to a maximum of 5 minutes or 5 cycles until micturition occurs and a midstream urine sample can be caught in a sterile container
Infants who spontaneously urinate after cleaning but prior to bladder stimulation will have their clean catch urine sent to the lab These cases will be considered successful non-invasive attempts
Infants who fail to produce urine will have further feedingfluid administration and bladder catheterization at the discretion of the MRP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None