LaryngotracheobronchitisNCT06959407
Efficacy Of Oral Dexamethasone Versus Parenteral Dexamethasone In The Management Of Mild To Moderate Croup
A study testing oral dexamethasone and intramuscular dexamethasone in people with Laryngotracheobronchitis and Croup, run by Arooj Khan at 1 site in Pakistan.
Trial summary
Croup (laryngotracheobronchitis) is a viral infection of the upper airway that causes throat swelling, leading to a barking cough, stridor, and hoarseness. It mainly affects children aged 6 months to 12 years, peaking at around 2 years. Most cases are mild and self-limiting. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Laryngotracheobronchitis, Croup
- What is being tested?
- oral dexamethasone and intramuscular dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 1 Mar 2025
- Phase
- Interventional
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient age 2 to 12 years
- Both genders
- Diagnosed with croup as operational definitions
Who cannot join
- Patients with chronic pulmonary disease like tuberculosis,
- Allergy or contraindication of corticosteroid (history of tuberous sclerosis, history of varicella infection during the past three weeks), to corticosteroids,
- history of corticosteroid administration during the last four weeks,
- foreign body
- patients with immunodeficiency disorder
Trial locations and contacts
1 site in 1 country.
About this study
Croup (laryngotracheobronchitis) is a viral infection of the upper airway that causes throat swelling, leading to a barking cough, stridor, and hoarseness. It mainly affects children aged 6 months to 12 years, peaking at around 2 years. Most cases are mild and self-limiting. Emergency treatments include cool mist, nebulized epinephrine, and steroids. Steroid therapy, particularly dexamethasone (oral or intramuscular), is commonly used, with recent studies suggesting intramuscular dexamethasone may be more effective. However, most research has focused on hospitalized patients, and there is a lack of local data for mild cases. This study aims to address that gap and improve patient counseling and future research
- Conditions
- Laryngotracheobronchitis, Croup
- Being tested
- oral dexamethasone, intramuscular dexamethasone
- Medical subject headings
- Croup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral dexamethasoneDrug
Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose
intramuscular dexamethasoneDrug
Patients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose
| Study group | Role | What they receive |
|---|---|---|
| Group A (oral dexamethasone ) | Active comparator | Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose Receives: Drug: oral dexamethasone |
| Group B (intramuscular dexamethasone ) | Active comparator | Patients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose Receives: Drug: intramuscular dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Settlement of symptoms of Croup
complete or partial settlement of symptoms i.e barking cough, inspiratory stridor, difficulty in breathing and hoarseness of voice.
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Oct 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LaryngotracheobronchitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arooj Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arooj Khan, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959407
- Sponsor's protocol ID
- 410/DME/KMC
- Status last verified
- Jan 2026
- First submitted
- 28 Apr 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith DK, McDermott AJ, Sullivan JF. Croup: Diagnosis and Management. Am Fam Physician. 2018 May 1;97(9):575-580.
PubMed 29763253Parker CM, Cooper MN. Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial. Pediatrics. 2019 Sep;144(3):e20183772. doi: 10.1542/peds.2018-3772. Epub 2019 Aug 15.
PubMed 31416827Lin SC, Lin HW, Chiang BL. Association of croup with asthma in children: A cohort study. Medicine (Baltimore). 2017 Sep;96(35):e7667. doi: 10.1097/MD.0000000000007667.
PubMed 28858086Peltz A, Wu CL, White ML, Wilson KM, Lorch SA, Thurm C, Hall M, Berry JG. Characteristics of Rural Children Admitted to Pediatric Hospitals. Pediatrics. 2016 May;137(5):e20153156. doi: 10.1542/peds.2015-3156. Epub 2016 Apr 11.
PubMed 27244794Parikh K, Hall M, Mittal V, Montalbano A, Gold J, Mahant S, Wilson KM, Shah SS. Comparative Effectiveness of Dexamethasone versus Prednisone in Children Hospitalized with Asthma. J Pediatr. 2015 Sep;167(3):639-44.e1. doi: 10.1016/j.jpeds.2015.06.038.
PubMed 26319919
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Oral Dexamethasone Versus Parenteral Dexamethasone In The Management Of Mild To Moderate Croup
- ClinicalTrials.gov ID
- NCT06959407
- Acronym / sponsor ID
- 410/DME/KMC
- Conditions
- Laryngotracheobronchitis, Croup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Arooj KhanUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 6 May 2025 (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.
Croup (laryngotracheobronchitis) is a viral infection of the upper airway that causes throat swelling, leading to a barking cough, stridor, and hoarseness. It mainly affects children aged 6 months to 12 years, peaking at around 2 years. Most cases are mild and self-limiting. Emergency treatments include cool mist, nebulized epinephrine, and steroids. Steroid therapy, particularly dexamethasone (oral or intramuscular), is commonly used, with recent studies suggesting intramuscular dexamethasone may be more effective. However, most research has focused on hospitalized patients, and there is a lack of local data for mild cases. This study aims to address that gap and improve patient counseling and future research
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (oral dexamethasone ) | Active comparator | Drug: oral dexamethasonePatients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose |
| Group B (intramuscular dexamethasone ) | Active comparator | Drug: intramuscular dexamethasonePatients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient age 2 to 12 years
- Both genders
- Diagnosed with croup as operational definitions
Key exclusion criteria (5 listed)
- Patients with chronic pulmonary disease like tuberculosis,
- Allergy or contraindication of corticosteroid (history of tuberous sclerosis, history of varicella infection during the past three weeks), to corticosteroids,
- history of corticosteroid administration during the last four weeks,
- foreign body
- patients with immunodeficiency disorder
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 |
|---|---|---|
| oral dexamethasonePatients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose | Drug | Group A (oral dexamethasone ) |
| intramuscular dexamethasonePatients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose | Drug | Group B (intramuscular dexamethasone ) |
Primary outcome
Settlement of symptoms of Croup
Time frame: within 24 hours
complete or partial settlement of symptoms i.e barking cough, inspiratory stridor, difficulty in breathing and hoarseness of voice.
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 29 Jan 2026.
- Results publication: PubMed 29763253Smith DK, McDermott AJ, Sullivan JF. Croup: Diagnosis and Management. Am Fam Physician. 2018 May 1;97(9):575-580.
- Results publication: PubMed 31416827Parker CM, Cooper MN. Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial. Pediatrics. 2019 Sep;144(3):e20183772. doi: 10.1542/peds.2018-3772. Epub 2019 Aug 15.
- Results publication: PubMed 28858086Lin SC, Lin HW, Chiang BL. Association of croup with asthma in children: A cohort study. Medicine (Baltimore). 2017 Sep;96(35):e7667. doi: 10.1097/MD.0000000000007667.
- Results publication: PubMed 27244794Peltz A, Wu CL, White ML, Wilson KM, Lorch SA, Thurm C, Hall M, Berry JG. Characteristics of Rural Children Admitted to Pediatric Hospitals. Pediatrics. 2016 May;137(5):e20153156. doi: 10.1542/peds.2015-3156. Epub 2016 Apr 11.
- Results publication: PubMed 26319919Parikh K, Hall M, Mittal V, Montalbano A, Gold J, Mahant S, Wilson KM, Shah SS. Comparative Effectiveness of Dexamethasone versus Prednisone in Children Hospitalized with Asthma. J Pediatr. 2015 Sep;167(3):639-44.e1. doi: 10.1016/j.jpeds.2015.06.038.
- Individual participant dataSharing planned: No
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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?
A study testing oral dexamethasone and intramuscular dexamethasone in people with Laryngotracheobronchitis and Croup, run by Arooj Khan at 1 site in Pakistan.
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 3 inclusion and 5 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 29 Jan 2026. 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 Pakistan. 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?
Settlement of symptoms of Croup (time frame: within 24 hours). 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 NCT06959407, which also lists 5 linked publications.
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 29 Jan 2026.