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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05382494




Registration number
NCT05382494
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022
Date last updated
19/09/2024

Titles & IDs
Public title
Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children
Scientific title
Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial
Secondary ID [1] 0 0
RCH HREC 81746
Universal Trial Number (UTN)
Trial acronym
MIST+
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disorder; Breathing-Related 0 0
Snoring 0 0
Obstructive Sleep Apnea of Child 0 0
Sleep Disorders in Children 0 0
Tonsillar Hypertrophy 0 0
Adenoidal Disorder 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mometasone Furoate 50mcg Nasal Spray
Treatment: Drugs - Sodium Chloride 0.9 % Nasal Spray

Experimental: Intranasal Steroids -

Placebo comparator: Intranasal Saline -


Treatment: Drugs: Mometasone Furoate 50mcg Nasal Spray
Intranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks

Treatment: Drugs: Sodium Chloride 0.9 % Nasal Spray
Intranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire
Assessment method [1] 0 0
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity. The proportion of participants in each treatment arm with resolution of symptoms at 6 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire < -1 at 12 weeks
Assessment method [1] 0 0
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity. The proportion of participants in each treatment arm with resolution of symptoms at 12 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
An improvement of score in parent completed Pediatric Sleep Questionnaire-sleep disordered breathing subscale (PSQ-SDB subscale) at week 6 when compared with baseline measured at the start of the intervention period (week 0)
Assessment method [2] 0 0
The Pediatric Sleep Questionnaire - sleep disordered breathing subscale is a validated questionnaire which contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behaviour, and other paediatric Obstructive Sleep Apnoea (OSA) features. Responses are "yes" = 1, "no" = 0, and "don't know"=missing. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
An improvement of score in parent completed Obstructive Sleep Apnoea-18 (OSA-18) questionnaire at week 6 when compared with baseline measured at the start of intervention period (week 0).
Assessment method [3] 0 0
The Obstructive Sleep Apnoea-18 (OSA-18) questionnaire is a validated questionnaire and consists of 18 questions concerning sleep disturbances, physical symptoms, emotional distress, daytime function, and caregiver concerns. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
An improvement of score in parent completed Pediatric Quality of Life Inventory (PedsQL) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Assessment method [4] 0 0
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
An improvement of score in parent completed Strengths and Difficulties Questionnaire (SDQ) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Assessment method [5] 0 0
The Strengths and Difficulties Questionnaire (SDQ) is a validated brief behavioural screening questionnaire about 3-16 year olds. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
An improvement of score in parent completed Glasgow Children's Benefit Inventory (GCBI) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Assessment method [6] 0 0
The Glasgow Children's Benefit Inventory (GCBI) consists of 24 questions on the consequences of a specified intervention on various aspects of the day-to-day child life, without reference to any specific symptoms, and it can be apply to children of any age. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Timepoint [6] 0 0
6 weeks
Secondary outcome [7] 0 0
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 weeks
Assessment method [7] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T\&A)?"
Timepoint [7] 0 0
6 weeks
Secondary outcome [8] 0 0
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 weeks
Assessment method [8] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T\&A)?"
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 months
Assessment method [9] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T\&A)?"
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids surgery (T&A) if recommended to them at 6 weeks
Assessment method [10] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Timepoint [10] 0 0
6 weeks
Secondary outcome [11] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 weeks
Assessment method [11] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 6 months
Assessment method [12] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 months
Assessment method [13] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 6 weeks
Assessment method [14] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Timepoint [14] 0 0
6 weeks
Secondary outcome [15] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 12 weeks
Assessment method [15] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Timepoint [15] 0 0
12 weeks
Secondary outcome [16] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 6 months
Assessment method [16] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 12 months
Assessment method [17] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Timepoint [17] 0 0
12 months
Secondary outcome [18] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 weeks
Assessment method [18] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Timepoint [18] 0 0
6 weeks
Secondary outcome [19] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 weeks
Assessment method [19] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Timepoint [19] 0 0
12 weeks
Secondary outcome [20] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 months
Assessment method [20] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Timepoint [20] 0 0
6 months
Secondary outcome [21] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 months
Assessment method [21] 0 0
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Timepoint [21] 0 0
12 months
Secondary outcome [22] 0 0
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 6 weeks (Likert Scale)
Assessment method [22] 0 0
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Timepoint [22] 0 0
6 weeks
Secondary outcome [23] 0 0
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 12 weeks (Likert Scale)
Assessment method [23] 0 0
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Timepoint [23] 0 0
12 weeks
Secondary outcome [24] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) defined by Ear Nose Throat (ENT) surgery at 6 months
Assessment method [24] 0 0
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery. The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [24] 0 0
6 months
Secondary outcome [25] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 12 months
Assessment method [25] 0 0
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery. The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [25] 0 0
12 months
Secondary outcome [26] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 6 months
Assessment method [26] 0 0
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity. The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [26] 0 0
6 months
Secondary outcome [27] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 12 months.
Assessment method [27] 0 0
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity. The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [27] 0 0
12 months
Secondary outcome [28] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 6 months
Assessment method [28] 0 0
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules. The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [28] 0 0
6 months
Secondary outcome [29] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 12 months
Assessment method [29] 0 0
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules. The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Timepoint [29] 0 0
12 months
Secondary outcome [30] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 6 months
Assessment method [30] 0 0
Parents will be emailed a survey with the following questions about any treatment their child may have had for SDB 1. Specialty of Dr seen and number of appointments 2. Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Timepoint [30] 0 0
6 months
Secondary outcome [31] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 12 months.
Assessment method [31] 0 0
Parents will be asked the following questions about any treatment their child may have had for SDB 1. Specialty of Dr seen and number of appointments 2. Medical Treatment used, and duration he study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm. of treatment
Timepoint [31] 0 0
12 months
Secondary outcome [32] 0 0
Number of adverse events (AEs) throughout the treatment phase
Assessment method [32] 0 0
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Timepoint [32] 0 0
6 weeks
Secondary outcome [33] 0 0
Number of adverse events (AEs) within the first week of the treatment
Assessment method [33] 0 0
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Timepoint [33] 0 0
1 week
Secondary outcome [34] 0 0
Compliance of medical therapy measured by weight of sent and returned bottles of medication
Assessment method [34] 0 0
Bottles will be weighed before they are given to participants and weighed when they are returned. The amount used will be calculated and used to determine if the participant was compliant with dosing. The amount of one spray of medication will be measured to allow for compliance to be calculated. Compliance with treatment will be calculated as the proportion of prescribed doses over 6 weeks that was consumed based on the weight of the bottles. The mean compliance will be summarised for the run-in period and both treatment arms. The proportion of participants with 80% and more compliance will be given for each treatment arm. The amount of one spray of medication will be measured to allow for compliance to be calculated.
Timepoint [34] 0 0
-6 weeks and 6 weeks (start of run-in phase to end of treatment phase)
Secondary outcome [35] 0 0
Clinical factors at baseline that are associated with response to interventions, based on statistical analysis
Assessment method [35] 0 0
Logistical regression models will be fitted to determine whether clinical factors at baseline or severity of SDB symptoms at baseline were associated with response to the intervention. Treatment arm, the symptom or factor of interest, and the interaction between the treatment arm and the symptom or factor will be included in this model. Symptoms or factors of interest include demographic factors, severity of SDB at baseline, history of atopy and history of tonsillitis.
Timepoint [35] 0 0
6 weeks

Eligibility
Key inclusion criteria
Each participant must meet all of the following criteria to be enrolled in this trial:

* Is between the ages of 3 and 12 years inclusive at the time of randomisation
* Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score = -1 on telehealth/phone screening
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:

* Has a BMI over the 97th centile for age and gender
* Has a history of tonsillectomy and/or adenoidectomy
* Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
* Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
* Has a history of nasal surgery or trauma which has not fully healed
* Has active tonsillitis or nasal infection (must be resolved prior to randomisation)
* Is assessed to have stertor (snoring) while awake at rest
* Has a known hypersensitivity to the study drug or its formulation
* Has used oral, intravenous, or intranasal steroids in the past 6 weeks. (Inhaled steroids for asthma will be allowed concomitantly during the study)
* Daily use of antihistamine or decongestant nasal sprays
* Is known to require systemic steroids prior to the completion of the study treatment phase
* Has had treatment with any other investigational drug within 6 months prior to randomisation
* Is unable to provide consent without the aid of an interpreter.
* In the opinion of the Investigator may be unable to follow the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Children's Hospital - Clayton
Recruitment hospital [2] 0 0
Royal Children's Hospital / Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Health
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Children's Hospital
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Kirsten Perrett
Address 0 0
Murdoch Children&#39;s Research Institute
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirsten Perrett
Address 0 0
Country 0 0
Phone 0 0
61399366278
Email 0 0
kirsten.perrett@rch.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data set that will be collected for this analysis of the MIST+ trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data, the following are required: a data access agreement must be signed between relevant parties; the MIST+ trial investigators must see and approve the analysis plan describing how the data will be analysed; there must be an agreement around appropriate acknowledgment; and any additional costs involved must be covered.

Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognised research institute, which has approved the proposed analysis plan.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Six months after the publication of the primary outcome
Available to whom?
Prior to releasing any data, the following are required: a data access agreement must be signed between relevant parties; the MIST+ trial investigators must see and approve the analysis plan describing how the data will be analysed; there must be an agreement around appropriate acknowledgment; and any additional costs involved must be covered.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.melbournechildrens.com/mctc/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05382494