NCT05350982

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 7, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

November 25, 2021

Last Update Submit

April 21, 2022

Conditions

Adrenal Insufficiency

Keywords

Salivary collectionSalivary cortisolSalivary cortisone

Outcome Measures

Primary Outcomes (1)

  • To determine whether the SalivaBio ± SaliPac can be used to collect 1mL (optimal volume) of saliva from children aged five years and under in two minutes or under.

    Salivary volume will be quantified by measuring change in mass of swab at start of collection compared to the end

    2 minutes

Secondary Outcomes (2)

  • To assess whether the SalivaBio ± SaliPac supports collection of 0.2ml saliva (minimum volume required for analysis of salivary GC) in two minutes or under.

    2 minutes

  • To determine the acceptability of the SalivaBio ± SaliPac in participants (neonates, infants and toddlers) through parental opinion using a parental questionnaire ranked from 1-10 with 10 being the most acceptable to the parent

    Within 10 minutes of sample collection

Study Arms (2)

Hospital Arm

Participants will be recruited to use the SalivaBio +/- SaliPac in a hospital setting. They will be provided with collecting instructions and will be guided by a member of the research team.

Device: SalivaBio +/- SaliPac

Stimulated Home Arm

10 participants will be randomly selected by a random number generator. This arm will also be conducted in the Hospital, and the collection using a SalivaBio +/- SaliPac will still be observed by a member of the research team. These participants will receive the same information as those in the Hospital Arm, but will receive minimal input. This is to establish whether the collection instructions provided would be suitable to use in the home environment.

Device: SalivaBio +/- SaliPac

Interventions

SalivaBio +/- SaliPacDEVICE

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

Hospital ArmStimulated Home Arm

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 5 and under

You may qualify if:

  • Patients attending Sheffield Children's Hospital Emergency Department, outpatients or a current inpatient
  • Patients attending the hospital for any reason but well enough to participate in the study (determined by the clinical care team)
  • Siblings of patients if appropriate
  • Individuals of any sex
  • Aged 5 years or under
  • Informed consent from parent(s)/carer(s)

You may not qualify if:

  • Aged 6 years or above
  • Mouth pathologies e.g., ulcers, infection, abscesses, injury or pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Location

Related Publications (1)

  • Tonge JJ, Keevil BG, Craig JN, Whitaker MJ, Ross RJ, Elder CJ. Salivary Steroid Collection in Children Under Conditions Replicating Home Sampling. J Clin Endocrinol Metab. 2022 Nov 23;107(11):3128-3136. doi: 10.1210/clinem/dgac419.

    PMID: 35961299DERIVED

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

April 28, 2022

Study Start

June 7, 2021

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

GB(1)