NCT06959407

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

October 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

April 28, 2025

Last Update Submit

January 28, 2026

Conditions

LaryngotracheobronchitisCroup

Outcome Measures

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.

    within 24 hours

Study Arms (2)

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

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

Drug: intramuscular dexamethasone

Interventions

oral dexamethasoneDRUG

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

Group A (oral dexamethasone )
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

Group B (intramuscular dexamethasone )

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (5)

  • Smith DK, McDermott AJ, Sullivan JF. Croup: Diagnosis and Management. Am Fam Physician. 2018 May 1;97(9):575-580.

    PMID: 29763253RESULT

  • 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.

    PMID: 31416827RESULT

  • 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.

    PMID: 28858086RESULT

  • 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.

    PMID: 27244794RESULT

  • 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.

    PMID: 26319919RESULT

MeSH Terms

Conditions

Croup

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

LaryngitisLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post Graduate Resident, Department of Child Health

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 6, 2025

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)