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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control group
The control group received routine nursing care
Other: control group
The control group received routine nursing care
observation group
the observation group was additionally managed with an integrated nursing and medical approach.
Other: observation group
the observation group was additionally managed with an integrated nursing and medical approach.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Hebei Province

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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