Adrenal InsufficiencyNITSNCT05350982
Neonatal, Infant and Toddler Salivary Study (NITS Study)
An observational study of Adrenal Insufficiency, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- SalivaBio +/- SaliPac
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2021to 20 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 5 and under
Who may be able to join
- 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)
Who cannot join
- Aged 6 years or above
- Mouth pathologies e.g., ulcers, infection, abscesses, injury or pain
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: A Prospective Feasibility Study of a Novel Salivary Collection Technique for the Measurement of Salivary Cortisol and Cortisone in Neonates, Infants and Toddlers
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.
Read the detailed description
The adrenal glands sit above the kidneys and are part of the body's endocrine system. They produce a number of different steroid hormones; those involved in metabolism (glucocorticoids, principally cortisol and its more inactive form, cortisone), salt and water balance (aldosterone) and sex steroids (oestrogen and testosterone). Measurement of steroids, in particular glucocorticoids, in saliva rather than blood samples, is gaining popularity as it offers a non-invasive collection technique, enabling sampling in outpatients, the community or the home environment, and therefore an improved patient experience.
Adrenal insufficiency (AI) describes the inability of the body to produce adequate levels of the vital stress hormone, cortisol. It is associated with considerable mortality and morbidity. There are numerous causes, both in adults and children. The commonest cause in children is AI secondary to steroid medication prescribed for inflammatory conditions such as arthritis and asthma. AI is usually permanent but, especially in those patients taking steroid medication, it may not be, and repeated testing may be required. Testing for AI requires measurement of cortisol. Cortisol levels change during the day (highest soon after waking) and increase in response to stress. There is a lack of data on what constitutes a normal cortisol level under different conditions in children, especially babies and very young children. The investigators would like to use salivary glucocorticoid sampling to study normal responses in children, in order to be able to better define what is abnormal, to ensure appropriate and safe management of children at risk of AI in the future. The current salivary collection techniques (SCT) require active patient participation, present a potential choking hazard, and are therefore unsuitable for very young children. The investigators have been working on a SCT suitable for neonates, infants, and toddlers. Our novel SCT uses a salivary steroid swab encased in a pacifier/dummy (SaliPac) and will enable study of normal adrenal gland function at different ages and under different conditions and disease states from which the investigators will construct normal reference ranges. The final step in the validation of the novel SCT is this patient study where usability, patient tolerability and carer acceptability will be examined.
- Conditions
- Adrenal Insufficiency
- Being tested
- SalivaBio +/- SaliPac
- Keywords
- Salivary collection, Salivary cortisol, Salivary cortisone
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalivaBio +/- SaliPacDevice
Sterile collection swab (SalivaBio), Modified dummy (SaliPac)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: SalivaBio +/- SaliPac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Salivary volume will be quantified by measuring change in mass of swab at start of collection compared to the end
Measured: 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
Assessed through the use of parent/carer questionnaires
Measured: Within 10 minutes of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start7 Jun 2021
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350982
- Sponsor's protocol ID
- SCH-2596
- Acronym
- NITS
- Status last verified
- Apr 2022
- First submitted
- 25 Nov 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35961299
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study of a Novel Salivary Collection Technique for the Measurement of Salivary Cortisol and Cortisone in Neonates, Infants and Toddlers
- ClinicalTrials.gov ID
- NCT05350982
- Acronym / sponsor ID
- NITS / SCH-2596
- Conditions
- Adrenal Insufficiency
- Keywords
- Salivary collection, Salivary cortisol, Salivary cortisone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The adrenal glands sit above the kidneys and are part of the body's endocrine system. They produce a number of different steroid hormones; those involved in metabolism (glucocorticoids, principally cortisol and its more inactive form, cortisone), salt and water balance (aldosterone) and sex steroids (oestrogen and testosterone). Measurement of steroids, in particular glucocorticoids, in saliva rather than blood samples, is gaining popularity as it offers a non-invasive collection technique, enabling sampling in outpatients, the community or the home environment, and therefore an improved patient experience.
Adrenal insufficiency (AI) describes the inability of the body to produce adequate levels of the vital stress hormone, cortisol. It is associated with considerable mortality and morbidity. There are numerous causes, both in adults and children. The commonest cause in children is AI secondary to steroid medication prescribed for inflammatory conditions such as arthritis and asthma. AI is usually permanent but, especially in those patients taking steroid medication, it may not be, and repeated testing may be required. Testing for AI requires measurement of cortisol. Cortisol levels change during the day (highest soon after waking) and increase in response to stress. There is a lack of data on what constitutes a normal cortisol level under different conditions in children, especially babies and very young children. The investigators would like to use salivary glucocorticoid sampling to study normal responses in children, in order to be able to better define what is abnormal, to ensure appropriate and safe management of children at risk of AI in the future. The current salivary collection techniques (SCT) require active patient participation, present a potential choking hazard, and are therefore unsuitable for very young children. The investigators have been working on a SCT suitable for neonates, infants, and toddlers. Our novel SCT uses a salivary steroid swab encased in a pacifier/dummy (SaliPac) and will enable study of normal adrenal gland function at different ages and under different conditions and disease states from which the investigators will construct normal reference ranges. The final step in the validation of the novel SCT is this patient study where usability, patient tolerability and carer acceptability will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital Arm | – | Device: SalivaBio +/- SaliPacParticipants 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. |
| Stimulated Home Arm | – | Device: SalivaBio +/- SaliPac10 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. |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 5 and under
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Aged 6 years or above
- Mouth pathologies e.g., ulcers, infection, abscesses, injury or pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalivaBio +/- SaliPacSterile collection swab (SalivaBio), Modified dummy (SaliPac) | Device | Hospital Arm, Stimulated Home Arm |
Primary outcome
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.
Time frame: 2 minutes
Salivary volume will be quantified by measuring change in mass of swab at start of collection compared to the end
2 secondary outcomes
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.
Time frame: 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
Time frame: Within 10 minutes of sample collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 35961299Tonge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.