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Point-of-care diagnostic test for neonatal infection

Development of a rapid and cost-effective Point-of-Care diagnostic test for the detection of Ureaplasma infection among premature neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
ISRCTN
Registry ID
ISRCTN17907106
Enrollment
100
Registered
2019-08-09
Start date
2019-10-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial infection in ventilated preterm neonates Infections and Infestations Bacterial infection in ventilated preterm neonates

Interventions

As part of routine care, ventilator tubes are cleared of mucus which can build up over time. It is this waste material, which we will use to assess the feasibility of the new device to detect Ureaplas

Sponsors

Cardiff Metropolitan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Babies born between 25 and 30 weeks gestational age

Exclusion criteria

Exclusion criteria: 1. Parents of any baby which are deemed not to have the capacity to consent 2. Parents of any baby who cannot speak English or Welsh 3. Baby receiving palliative care 4. Parents are under the age of 16 years 5. Baby under a care order 6. Any other reason that the clinical lead feels it may be inappropriate.

Design outcomes

Primary

MeasureTime frame
1. Sensitivity of the new diagnostic device - estimates of the new diagnostic device positive rate in comparison with qPCR methods currently used. 2. Specificity of the new diagnostic device - estimates of the new diagnostic device negative rate in comparison with qPCR methods currently used. 3. Estimate of the positive predictive and negative predictive value of the new diagnostic device as other basic measures of diagnostic accuracy given their relationship to sensitivity and specificity through disease prevalence .

Secondary

MeasureTime frame
Relationship between qPCR copy numbers and the new diagnostic device values obtained using regression analysis

Countries

United Kingdom, Wales

Contacts

Public ContactMichael Beeton
mbeeton@cardiffmet.ac.uk+442920205557

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026