NCT02939690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

September 22, 2016

Last Update Submit

May 1, 2018

Conditions

Central Venous Catheterization

Keywords

CatheterUmbilical veinNeonate

Outcome Measures

Primary Outcomes (1)

  • Proportion of correctly inserted UVC at optimum catheter tip position

    within 12 hours

Secondary Outcomes (2)

  • Number of readjustment of UVC

    within first 2 weeks

  • Comparison of UVC tip position between two methods based on based growth status at birth (i.e.AGA, SGA, LGA)

    within 12 hours

Study Arms (2)

UVC and surface measurement formula

EXPERIMENTAL

UVC insertion depth = Umbilicus to nipple distance minus 1cm

Device: UVCDevice: Ultrasound

UVC and Birth weight based formula

ACTIVE COMPARATOR

UVC insertion depth=\[(3× birth weight (Kg) + 9)/2+1)\] cm

Device: UVCDevice: Ultrasound

Interventions

UVCDEVICE

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

Also known as: UVC insertion using birth weight based calculation
UVC and Birth weight based formula
UltrasoundDEVICE
Also known as: Ultrasound assessment of UVC
UVC and Birth weight based formulaUVC and surface measurement formula

Eligibility Criteria

Age1 Minute - 2 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (7)

  • 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.

    PMID: 3728405RESULT

  • 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.

    PMID: 25611793RESULT

  • 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.

    PMID: 26265678RESULT

  • 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.

    PMID: 25154935RESULT

  • 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.

    PMID: 22155219RESULT

  • 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.

    PMID: 5906629RESULT

  • 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.

    PMID: 31383945DERIVED

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Amuchou S Soraisham, MD, DM,

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

September 22, 2016

First Posted

October 20, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

CA(1)