NCT06862895

Brief Summary

The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician The main questions aims to answer:

  • Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis?
  • Does educational program improve mothers knowledge and practice regarding chest physiotherapy? Researcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

January 29, 2025

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • change in Clinical Outcomes of Infants with Bronchiolitis

    changing of oxygen saturation( SPO2) \<90% to normal level SPO2\>92%

    baseline

  • change in physiological outcomes of Infants with Bronchiolitis

    change in respiratory rate from abnormal to normal (0-3 month RR:35-55 3-6 month RR:30-45 6-12 month RR:25-40) breath per minute

    baseline

Secondary Outcomes (2)

  • Improvement in Knowledge of Mother's

    After 3 days

  • Improvement in practices of Mother's

    After 3 days

Study Arms (2)

intervention group

EXPERIMENTAL

chest physiotherapy

Other: chest physiotherapy

control group

NO INTERVENTION

no intervention

Interventions

Chest Physiotherapy is including various techniques, in this study classical CPT was used to be applied to participants

intervention group

Eligibility Criteria

Age1 Month - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on auscultation.

You may not qualify if:

  • Children with contraindication of chest physiotherapy (ex. Fracture, recent surgery)
  • Children who intubated and admitted to Intensive Care Unit (ICU).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawler Medical University

Erbil, Kurdistan, 61002, Iraq

RECRUITING

MeSH Terms

Conditions

BronchiolitisInfant, Newborn, Diseases

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Nazar Othman, Assist.Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

January 29, 2025

First Posted

March 6, 2025

Study Start

January 1, 2025

Primary Completion

February 1, 2025

Study Completion

September 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations