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NCT03535311
Estimating Insertion Length of Umbilical Catheters in Newborn Infants
trial testing Measurement of sternal-notch to umbilicus distance in Infant, Newborn, Diseases in 113 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | Cardiff and Vale University Health Board |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 113 |
| Start date | 21 May 2018 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Measurement of sternal-notch to umbilicus distance
Conditions studied
- Infant, Newborn, Diseases — all drugs for Infant, Newborn, Diseases →
Sponsor
Cardiff and Vale University Health Board
Who can join
Under 1 Week, any sex, with Infant, Newborn, Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03535311
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Other Cardiff and Vale University Health Board trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03535311 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cardiff and Vale University Health Board
- Last refreshed: 31 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03535311.
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