NCT03814954

Brief Summary

Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration 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

January 1, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

2.7 years

First QC Date

January 21, 2019

Last Update Submit

August 28, 2022

Conditions

Respiratory Distress Score

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Patients hospitalization duration will be recorded

    5 days

Secondary Outcomes (1)

  • Respiratory distress scoring

    5 days

Study Arms (2)

Salbutamol

ACTIVE COMPARATOR

Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.

Drug: Salbutamol

Epinephrine

EXPERIMENTAL

Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.

Drug: Epinephrine

Interventions

SalbutamolDRUG

At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status

Salbutamol
EpinephrineDRUG

At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status

Epinephrine

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with acute bronchiolitis.

You may not qualify if:

  • Children with congenital heart disease or
  • chronic lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

AlbuterolEpinephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Mariam Rajab, MD

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 24, 2019

Study Start

January 1, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

August 30, 2022

Record last verified: 2022-08

Locations

LE(1)