Estimating Insertion Length of Umbilical Catheters in Newborn Infants

NCT03535311 | Completed

• 2 other identifiers: 18/WA/0117236837
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Insertion Length of Umbilical Catheters Umbilical catheters, inserted through the umbilical artery and vein of newborn babies at birth, are crucial in neonatal care of sick babies. They allow delivery of medication and fluids and to provide access for blood sampling and blood pressure monitoring. Incorrect positioning of the catheter tip due to under- or over-insertion length can lead to significant complications in newborn infants. Currently, several methods are used to estimate insertion length of umbilical catheters based on one of two beliefs; that the insertion length of the umbilical catheter is proportional to either the infant's birth weight or an external length measurement. Several research studies have identified that existing methods often result in incorrect positioning of umbilical catheters, with studies showing a variable range of proportions of umbilical lines being correctly or incorrectly placed. In particular, formulas for predicting umbilical venous catheter (UVC) length have been shown to be particularly unreliable. The investigators propose a new observational study which uses a novel but easy-to-measure external length measurement, the sternal notch (upper end of breast-bone) to umbilicus (upper margin of belly-button) length, along with other clinical information to develop a more reliable formula for estimating the insertion length of umbilical venous and arterial catheters to an appropriate length. Our study population will include newborn babies admitted to the neonatal unit requiring umbilical venous (UVC) and/or arterial catheterisation (UAC) over a two-year period. Demographic information will be recorded for each child and once position has been confirmed, the new external length will be measured. New formulae for estimating required insertion length will be developed using statistical (regression) analysis.

Conditions

Infant, Newborn, Diseases

Outcome Measures

Primary Outcomes (1)

• New Formula estimating insertion length of umbilical lines

  3 years

Interventions

Measurement of sternal-notch to umbilicus distance PROCEDURE

* The sternal notch to upper border of umbilicus length measurement in centimetres. * The length of the umbilical stump in centimetres. * The length of the UVC and/or UAC inserted in centimetres which will be identified using the printed markers on the catheter. The marker which is closest to the end of the umbilical stump will be the recorded value. * The length of the UVC and/or UAC in centimetres when the umbilical stump length is subtracted.

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study sample will include all neonates admitted to the neonatal unit at the University Hospital of Wales, Cardiff, who require UACs and UVCs inserted for their usual clinical care. Participants will be identified through new admissions to the neonatal unit over a two-year period. All infants who have umbilical lines inserted as part of their normal clinical care will be included into the study. Parents will be given an information leaflet explaining the background and providing details of the data collection for the study. Once they have had an opportunity to read the information and ask questions, parents will be asked for written consent for their infant to be included in the study.

You may qualify if:

• Infants admitted to the Neonatal Intensive Care Unit at the University Hospital of Wales and having umbilical arterial and/or venous lines inserted for usual clinical care.
• Have correctly sited final position of umbilical catheters as per definition (UVC between T8-9 and outside cardiac silhouette, UAC between T6-10) inserted by the clinical team for usual clinical care.
• Written informed consent from parents/guardians to participate in the study.

You may not qualify if:

• Major abdominal wall defects
• Suspected or confirmed skeletal dysplasia
• Peritonitis
• Hydrops fetalis
• Necrotising enterocolitis
• Major congenital abnormalities affecting birth-weight or external features, which makes assessment of line position difficult.
• Seriously ill infants who are not expected to survive will be excluded from the study, and their parents will not be approached. However, the number of such infants will be included in the summary statistics while reporting the study, so as to account for all line insertions during the study period (no data will be collected from such infants).

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Cardiff University: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, South Glamorgan, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Neonatal Medicine

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: May 21, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)