Clinical trial NCT01119911: Blood Sampling Through Peripheral Venous Catheter in Infants
Official title: Blood Sampling Through Peripheral Venous Catheter for Selected Basic Analytes in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: Blood sampling
Venipuncture
Peripheral venous catheter
Complete blood count
Basic chemistry
Hemolysis
Peripheral venous catheter replaces venipuncture.
Peripheral venous catheter blood sampling reduces pain.
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants under 2 years of age, admitted to the Departments of Pediatrics and Pediatric Surgery, Meir Medical Center, who have a functioning peripheral venous catheter and require repeated blood sampling for diagnostic purposes.

Brief summary: We hypothesize that peripheral venous catheter used for fluid administration can replace venipuncture blood sampling for selected basic analytes and thus reduce pain in infants under 2 years of age.

Detailed description: Multiple venipunctures in hospitalized children result in physical and emotional distress. Recently, we have found that blood sampling via peripheral venous catheter used for fluid administration in children significantly reduces pain and, except for glucose, can replace venipuncture for determining complete blood count and basic chemistry analytics, including white and red blood cell counts, hemoglobin and hematocrit levels, mean corpuscular volume, mean corpuscular hemoglobin level, red blood cell distribution width, platelet count, mean platelet volume, and sodium, potassium, chloride, and urea levels (Berger-Achituv S, Budde-Schwartzman B. Ellis MH, Shenkman Z. Erez I. Blood Sampling through Peripheral Venous Catheters for Selected Basic Analytes in Children. Pediatrics. In press).

The goal of this study is to investigate whether blood sampling via peripheral venous catheter used for fluid administration can significantly reduces pain and replace venipuncture for determining complete blood count and basic chemistry analytics in infants under 2 years of age.

Eligibility criteria: Inclusion Criteria:

* Infants under 2 years of age.
* Only hemodynamically stable infants.
* Infants with peripheral venous catheter present for less than 72 hours.
* At least 20 mL of fluids have been infused intravenously at the time of blood sampling.

Exclusion Criteria:

* Infants with signs of catheter-related thrombophlebitis.

Primary outcomes:
measure: To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices.
timeFrame: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.
Secondary outcomes:
measure: Assessment of infant's mood during procedures.
timeFrame: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Sivan Berger-Achituv, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center
name: Ilan Erez, Dr
role: PRINCIPAL_INVESTIGATOR
References: