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Umbilical Venous Catheter Insertion Depth in Neonates

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ClinicalTrials.gov Identifier: NCT02939690
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Amuchou Soraisham, University of Calgary

Brief Summary:
In this randomized clinical study, neonates who require umbilical venous catheter (UVC) insertion as part of their routine care at anytime during their NICU admission will be randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth (umbilicus to the nipple in cm minus 1 (UN - 1) or birth weight based formula ([(3× birth weight (Kg) + 9)/2+1)]. UVC will be inserted under sterile condition as per unit protocol. To verify the UVC tip position, a thoracoabdominal radiograph will be taken. In addition, the investigators will do a ultrasound of the heart to assess the exact location of the catheter tips as soon as possible but within 6 hours of insertion.

Condition or disease Intervention/treatment Phase
Central Venous Catheterization Device: UVC Device: Ultrasound Not Applicable

Detailed Description:

Background:

The ideal position of UVC) tip to minimize complications is just outside the heart at the junction of inferior vena cava and right atrium. UVC related complications are mainly due to catheter malposition. Accurate prediction of insertion length of UVC as well as confirmation of the position after insertion by radiograph or with ultrasound is very important to avoid complications. UVC malposition with subsequent re-positioning exposes these fragile infants to unnecessary handling, further radiologic exposure and increasing risk of infection.

The commonly used formulas to estimate the depth of umbilical catheter include Dunn's shoulder to umbilical length graph and a birth weight based formula proposed by Shukla and Ferrara in 1986. In Calgary, the most commonly used method for estimation of UVC insertion length is the birth weight based formula (i.e. UVC insertion length = (3 x birth weight + 9)/2 +1). The success rate of achieving the optimum position of catheter tip using this formula ranges from 31-40%. A recent retrospective study reported the use of different surface markers for calculating UVC insertion depth. A distance from base of umbilicus to nipple distance (UN)-1 cm provided the best and most accurate insertion depth of UVC. This formula had accuracy rate of 84% compared with 57% accuracy rate with birth weight based formula.

The objectives of our study are:

  1. To compare accuracy rate between UVC insertion length estimated by using two formula (i.e. umbilicus to the nipple distance in cm minus 1 (UN - 1) and Shukla's birth weight based formula ([(3× birth weight (Kg) + 9)/2+1)] in achieving optimum UVC tip position
  2. To compare the accuracy rate of UVC tip position between two methods based on growth status of neonates

Methods:

This is a randomized clinical study. All infants who require UVC insertion as part of their routine care at anytime during their hospital admission are eligible for the study. Infants with hydrops fetalis, abdominal wall defects, congenital diaphragmatic hernia and/or major structural heart disease will be excluded from the study.

When a newborn baby needs UVC central line insertion, neonate will be randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth. UVC will be inserted under sterile condition as per unit protocol. To verify the UVC tip position, a thoracoabdominal radiograph will be taken. In addition,the investigators will do a ultrasound of the the heart to assess the exact location of the catheter tips as soon as possible but within 6 hours of insertion.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Estimation of Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurement: A Randomized Trial
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UVC and surface measurement formula
UVC insertion depth = Umbilicus to nipple distance minus 1cm
Device: UVC
UVC insertion depth calculated by umbilicus to nipple distance-1
Other Name: UVC insertion using surface measurement

Device: Ultrasound
Other Name: Ultrasound assessment of UVC

Active Comparator: UVC and Birth weight based formula
UVC insertion depth=[(3× birth weight (Kg) + 9)/2+1)] cm
Device: UVC
UVC insertion depth calculated by [(3× birth weight (Kg) + 9)/2+1)]
Other Name: UVC insertion using birth weight based calculation

Device: Ultrasound
Other Name: Ultrasound assessment of UVC




Primary Outcome Measures :
  1. Proportion of correctly inserted UVC at optimum catheter tip position [ Time Frame: within 12 hours ]

Secondary Outcome Measures :
  1. Number of readjustment of UVC [ Time Frame: within first 2 weeks ]
  2. Comparison of UVC tip position between two methods based on based growth status at birth (i.e.AGA, SGA, LGA) [ Time Frame: within 12 hours ]
    AGA: appropriate for gestational age (i.e birth weight between 10th and 90th percentile for gestational age); SGA: Small for gestational age (i.e. birth weight <10th percetile for gestational age); LGA: large for gestational age (i.e.birth weight >90th percentile for gestational age) using Fentons growth chart for preterm infants and WHO growth chart for term infants



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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All infants who require UVC insertion as part of their routine care at anytime during their NICU admission

Exclusion Criteria:

  • Infants with hydrops fetalis, infants with abdominal wall defects, congenital diaphragmatic hernia and major structural heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939690


Locations
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Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Amuchou S Soraisham, MD, DM, University of Calgary

Publications of Results:
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Responsible Party: Amuchou Soraisham, Associate Professor of Pediatrics, University of Calgary
ClinicalTrials.gov Identifier: NCT02939690     History of Changes
Other Study ID Numbers: 16-1303
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Amuchou Soraisham, University of Calgary:
Catheter
Umbilical vein
Neonate