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CompletedNCT06959407Updated Jan 29, 2026

Efficacy Of Oral Dexamethasone Versus Parenteral Dexamethasone In The Management Of Mild To Moderate Croup

An interventional study of oral dexamethasone and intramuscular dexamethasone in Laryngotracheobronchitis and Croup, sponsored by Arooj Khan. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Arooj Khan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Laryngotracheobronchitis
  • Croup

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03

In context

Croup

18 studies on the registry are indexed under Croup; 2 are open to participants now.

This study's enrollment of 200 is above the median of 86 across 12 interventional studies indexed under Croup.

Browse Croup studies →

Lead sponsor

Arooj Khan is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient age 2 to 12 years
  • Both genders
  • Diagnosed with croup as operational definitions

Exclusion criteria

Exclusion Criteria:

  • Patients with chronic pulmonary disease like tuberculosis,
  • Allergy or of (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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Group A (oral dexamethasone )

    Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose

    Drug: oral dexamethasone

  • Active comparator
    Group B (intramuscular dexamethasone )

    Patients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose

    Drug: intramuscular dexamethasone

Interventions

  • Patients in group A will receive oral dexamethasone which will be administered at 0.6mg/kg as single dose

  • Patients in group B will receive intramuscular dexamethasone which will be administered in 0.6mg/kg strength as intra-gluteal injection as single dose

06

What researchers measure

Primary outcomes

  1. Settlement of symptoms of Croup

    complete or partial settlement of symptoms i.e barking cough, inspiratory stridor, difficulty in breathing and hoarseness of voice.

    Time frame: within 24 hours

07

Study locations

1 site
  • Khyber Teaching Hospital
    Peshawar, KPK 25000, Pakistan
08

References and documents

Publications

  • Smith DK, McDermott AJ, Sullivan JF. Croup: Diagnosis and Management. Am Fam Physician. 2018 May 1;97(9):575-580. PubMed 29763253 ↗
  • Parker 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 31416827 ↗
  • Lin 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 28858086 ↗
  • Peltz 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 27244794 ↗
  • Parikh 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2024 to primary completion in Mar 2025, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2025
First posted
May 6, 2025
StartActual
Oct 1, 2024
Primary completionActual
Mar 1, 2025
CompletionActual
Mar 1, 2025
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06959407
Lead sponsor
Arooj Khan
Responsible party
Arooj Khan (Post Graduate Resident, Department of Child Health, Khyber Teaching Hospital) — Sponsor-investigator
First posted
May 6, 2025
Start date
Oct 1, 2024
Primary completion
Mar 1, 2025
Completion
Mar 1, 2025
Last update
Jan 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone

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