Blood Sampling Through Peripheral Venous Catheter in Infants

Blood Sampling Through Peripheral Venous Catheter for Selected Basic Analytes in Infants

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: Blood sampling from peripheral venous catheter.

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Erez Ilan, MD; Phone Number: 972-9-7472344; Email: erezi@clalit.org.il

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Recruiting
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices.	Comparisons of complete blood count (including white and red blood cells, hemoglobin, hematocrit, mean corpuscular volume and hemoglobin, red cell distribution width, platelets, mean platelet volume) and basic chemistry indices (including sodium, potassium, glucose, chloride, urea) will be performed and hemolysis will be documented.	Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of infant's mood during procedures.	The investigator will record infant's mood (calm, distressed/crying, crying vigorously) during blood sampling from peripheral venous catheter and direct venipuncture.	Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Sivan Berger-Achituv, MD, Meir Medical Center; Principal Investigator: Ilan Erez, Dr, Meir Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion: December 7, 2022
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (Estimate): May 10, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2012
• Last Update Submitted That Met QC Criteria: March 16, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• 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.
• Other Study ID Numbers: MMC10086-09CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No