- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06945991
Application and Effect Evaluation of Integrated Nursing and Medical Management in Pediatric Lobar Pneumonia
April 22, 2025 updated by: Linlin Liu, Children's Hospital of Hebei Province
Integrated nursing and medical management significantly improves clinical symptoms and pulmonary function in children with lobar pneumonia, shortens hospitalization duration, reduces complication rates, and enhances caregiver satisfaction.
These findings support its broad clinical applicability and value.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study aims to evaluate the clinical efficacy of integrated nursing and medical management in the treatment of pediatric lobar pneumonia.
Specifically, it assesses its impact on symptom relief, pulmonary function recovery, inflammatory response control, duration of hospitalization, and caregiver satisfaction.
Fifty pediatric patients diagnosed with lobar pneumonia and admitted to our hospital between January and December 2023 were selected and randomly assigned to either the observation group or the control group (n = 25 each) using a random number table.
The control group received routine nursing care, while the observation group was additionally managed with an integrated nursing and medical approach.
The two groups were compared in terms of duration of fever, cough, pulmonary rales, antibiotic treatment, length of hospital stay, pulmonary function parameters (FEV₁, FVC, FEV₁/FVC), inflammatory markers (CRP, WBC, PCT, LDH), overall treatment efficacy, caregiver satisfaction, and incidence of adverse events.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shijiazhuang, China, 050000
- Hebei Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Fifty pediatric patients diagnosed with lobar pneumonia and admitted to our hospital between January and December 2023 were selected and randomly assigned to either the observation group or the control group (n = 25 each) using a random number table.
Description
Inclusion Criteria:
- (1) Met the diagnostic criteria for lobar pneumonia, presenting with symptoms such as fever, cough, and pulmonary rales, and confirmed by laboratory tests and chest X-ray;
- (2) Aged between 1 and 12 years;
- (3) Informed consent was obtained from the child's legal guardians.
Exclusion Criteria:
- (1)Presence of other concurrent respiratory diseases;
- (2) Congenital or acquired airway malformations, or airway foreign bodies;
- (3) Impaired hepatic or renal function;
- (4) Presence of other systemic diseases;
- (5) Cognitive impairment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
The control group received routine nursing care
|
The control group received routine nursing care
|
|
observation group
the observation group was additionally managed with an integrated nursing and medical approach.
|
the observation group was additionally managed with an integrated nursing and medical approach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Clinical Resolution of Symptoms
Time Frame: From admission until discharge (up to 14 days).
|
Duration (in days) from hospital admission until resolution of three key symptoms: fever (axillary temperature <37.3°C for 24h), cough (absence of cough for 48h), and pulmonary rales (absence on auscultation).
Assessed daily by blinded clinicians.
|
From admission until discharge (up to 14 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pulmonary Function (FEV₁, FVC, FEV₁/FVC)
Time Frame: Baseline (T0) and discharge (T1; up to 14 days).
|
Absolute change in spirometry-measured FEV₁ (L), FVC (L), and FEV₁/FVC ratio (%) from admission to discharge.
Assessed using standardized spirometry protocols.
|
Baseline (T0) and discharge (T1; up to 14 days).
|
|
Reduction in Inflammatory Markers (CRP, PCT, WBC, LDH)
Time Frame: Baseline (T0) and discharge (T1; up to 14 days).
|
Percent reduction in serum CRP (mg/L), PCT (ng/mL), WBC (×10⁹/L), and LDH (U/L) levels from admission to discharge.
|
Baseline (T0) and discharge (T1; up to 14 days).
|
|
Length of Hospital Stay
Time Frame: Up to 14 days.
|
Total days from admission to discharge, documented from electronic health records.
|
Up to 14 days.
|
|
Parental Satisfaction Rate
Time Frame: At discharge (T1; up to 14 days).
|
Proportion of caregivers reporting "very satisfied" or "satisfied" on a 4-point Likert scale (very satisfied/satisfied/neutral/dissatisfied) at discharge.
|
At discharge (T1; up to 14 days).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Complications
Time Frame: From admission to discharge (up to 14 days).
|
Proportion of patients experiencing adverse events (e.g., hemoptysis, pneumothorax, bronchospasm) during hospitalization, verified by imaging/lab reports.
|
From admission to discharge (up to 14 days).
|
|
Antibiotic Usage Duration
Time Frame: From admission to discontinuation (up to 14 days).
|
Total days of intravenous/oral antibiotic therapy, recorded from medication logs.
|
From admission to discontinuation (up to 14 days).
|
|
Adherence to Rehabilitation Protocols
Time Frame: Daily during hospitalization (up to 14 days).
|
Compliance with respiratory exercises (e.g., % of scheduled postural drainage sessions completed), tracked via nursing logs.
|
Daily during hospitalization (up to 14 days).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2023
Primary Completion (Actual)
March 20, 2024
Study Completion (Actual)
October 18, 2024
Study Registration Dates
First Submitted
April 16, 2025
First Submitted That Met QC Criteria
April 22, 2025
First Posted (Actual)
April 27, 2025
Study Record Updates
Last Update Posted (Actual)
April 27, 2025
Last Update Submitted That Met QC Criteria
April 22, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. 202222-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Satisfaction
-
Shaukat Khanum Memorial Cancer Hospital & Research...CompletedSatisfaction, Patient | SatisfactionPakistan
-
Fu Jen Catholic UniversityRecruitingSatisfaction, PersonalTaiwan
-
Duke UniversityCompletedPatient Satisfaction | Clinician SatisfactionUnited States
-
Necmettin Erbakan UniversityGazi UniversityCompletedSatisfaction, Personal | KnowledgeTurkey (Türkiye)
-
University Hospital, BordeauxNot yet recruitingPregnancy | Telemedicine | Anesthesia | SatisfactionFrance
-
Necmettin Erbakan UniversityCompletedSatisfaction | Waste ManagementTurkey (Türkiye)
-
Ernesto LosavioItem OxygenNot yet recruitingSatisfaction | Usability | Acceptability | User Experience
-
Pamukkale UniversityCompletedFlexibility | Life Satisfaction | Body AwarenessTurkey (Türkiye)
-
Nanne KleefstraCompletedPatient Satisfaction | Doctor Satisfaction | Duration of ConsultationNetherlands
-
Brigham and Women's HospitalUniversity of Illinois at Urbana-Champaign; American Pistachio Growers; Quest... and other collaboratorsActive, not recruitingCognition | Life Satisfaction | Cardiometabolic Risk FactorsUnited States
Clinical Trials on control group
-
Tasly Pharmaceutical Group Co., LtdCompleted
-
Chengdu Sport UniversityNot yet recruiting
-
Hanlim Pharm. Co., Ltd.Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
International University of La RiojaCompletedPsychosis | Therapy | PsychologicalSpain
-
The First Affiliated Hospital of Zhejiang Chinese...Not yet recruitingAdolescent Idiopathic ScoliosisChina
-
The University of Hong Konghong Kong Cancer FundCompletedBreast Cancer | Yoga Therapy | Shoulder Joint Motion | Scar Contracture
-
Romanian Society of Anesthesia and Intensive CareUniversity of Medicine and Pharmacy "Victor Babes" Timisoara; Timişoara County...Completed
-
Helse Stavanger HFUniversity of Oslo; Oslo University Hospital; University College, London; Aalborg... and other collaboratorsNot yet recruitingPTSD | Personality Disorder, Borderline | Personality Disorder | Personality Trait | PTSD - Post Traumatic Stress Disorder | Personality Type | PTSD and Trauma-related Symptoms | Personality Disorder, Avoidant | Affect Consciousness | Mentalization | Reflective FunctioningNorway