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Neonatal, Infant and Toddler Salivary Study (NITS Study)

NCT05350982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-04-28

No results posted yet for this study

Summary

Currently, the only way to analyse glucocorticoids for the screening or diagnosis of AI in young children is via plasma obtained by invasive capillary or venous blood sampling. Thus, there is an unmet need for a safe and simple salivary collection technique for use in children under the age of six years. The development of the SalivaBio offers potential for salivary collection, which is safe, easy and less-invasive than current practice. The SaliPac has been developed to offer a more tolerable and pleasant way of sampling saliva using a SalivaBio in very young children which the investigators envisage being used by parents/carers at home to sample and then post to the hospital for GC analysis.

Conditions

Interventions

DEVICE

SalivaBio +/- SaliPac

Sterile collection swab (SalivaBio), Modified dummy (SaliPac)

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2021-08-20
Completion
2021-08-20

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350982 on ClinicalTrials.gov