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Central Venous CatheterizationNCT02939690

Umbilical Venous Catheter Insertion Depth in Neonates

A study testing UVC and Ultrasound in people with Central Venous Catheterization, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 minute to 2 weeks
Conditions the study is for
Central Venous Catheterization
What is being tested?
UVC and Ultrasound
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
Oct 2016to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 2 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Foothills Medical Center

    Calgary, Alberta, T2N 2T9

Other trials in Canada

About this study

Official title: Estimation of Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurement: A Randomized Trial

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.

Read the 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.

Being tested
UVC, Ultrasound
Keywords
Catheter, Umbilical vein, Neonate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UVCDevice

    Also called UVC insertion using birth weight based calculation

    UVC insertion depth calculated by [(3× birth weight (Kg) + 9)/2+1)]

  • UVCDevice

    Also called UVC insertion using surface measurement

    UVC insertion depth calculated by umbilicus to nipple distance-1

  • UltrasoundDevice

    Also called Ultrasound assessment of UVC

Study groups in NCT02939690
Study groupRoleWhat they receive
UVC and surface measurement formulaExperimentalUVC insertion depth = Umbilicus to nipple distance minus 1cm
Receives: Device: UVC; Device: Ultrasound
UVC and Birth weight based formulaActive comparatorUVC insertion depth=[(3× birth weight (Kg) + 9)/2+1)] cm
Receives: Device: UVC; Device: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of correctly inserted UVC at optimum catheter tip position

    Measured: within 12 hours

Secondary outcomes (2)

  1. Number of readjustment of UVC

    Measured: 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)

    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

    Measured: within 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02939690
Sponsor's protocol ID
16-1303
Status last verified
May 2018
First submitted
22 Sep 2016
Last updated
2 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Shukla H, Ferrara A. Rapid estimation of insertional length of umbilical catheters in newborns. Am J Dis Child. 1986 Aug;140(8):786-8. doi: 10.1001/archpedi.1986.02140220068034.

    PubMed 3728405

  • Gupta AO, Peesay MR, Ramasethu J. Simple measurements to place umbilical catheters using surface anatomy. J Perinatol. 2015 Jul;35(7):476-80. doi: 10.1038/jp.2014.239. Epub 2015 Jan 22.

    PubMed 25611793

  • Kieran EA, Laffan EE, O'Donnell CP. Estimating umbilical catheter insertion depth in newborns using weight or body measurement: a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jan;101(1):F10-5. doi: 10.1136/archdischild-2014-307668. Epub 2015 Aug 11.

    PubMed 26265678

  • Harabor A, Soraisham A. Rates of intracardiac umbilical venous catheter placement in neonates. J Ultrasound Med. 2014 Sep;33(9):1557-61. doi: 10.7863/ultra.33.9.1557.

    PubMed 25154935

  • Michel F, Brevaut-Malaty V, Pasquali R, Thomachot L, Vialet R, Hassid S, Nicaise C, Martin C, Panuel M. Comparison of ultrasound and X-ray in determining the position of umbilical venous catheters. Resuscitation. 2012 Jun;83(6):705-9. doi: 10.1016/j.resuscitation.2011.11.026. Epub 2011 Dec 6.

    PubMed 22155219

  • Dunn PM. Localization of the umbilical catheter by post-mortem measurement. Arch Dis Child. 1966 Feb;41(215):69-75. doi: 10.1136/adc.41.215.69. No abstract available.

    PubMed 5906629

  • Sheta A, Kamaluddeen M, Soraisham AS. Umbilical venous catheter insertion depth estimation using birth weight versus surface measurement formula: a randomized controlled trial. J Perinatol. 2020 Apr;40(4):567-572. doi: 10.1038/s41372-019-0456-0. Epub 2019 Aug 5.

    PubMed 31383945

Questions about this trial

What is this clinical trial studying?

A study testing UVC and Ultrasound in people with Central Venous Catheterization, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of correctly inserted UVC at optimum catheter tip position (time frame: within 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02939690, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.

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