NCT06945991

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

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 13, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

April 16, 2025

Last Update Submit

April 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to Clinical Resolution of Symptoms

    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 Outcomes (4)

  • Change in Pulmonary Function (FEV₁, FVC, FEV₁/FVC)

    Baseline (T0) and discharge (T1; up to 14 days).

  • Reduction in Inflammatory Markers (CRP, PCT, WBC, LDH)

    Baseline (T0) and discharge (T1; up to 14 days).

  • Length of Hospital Stay

    Up to 14 days.

  • Parental Satisfaction Rate

    At discharge (T1; up to 14 days).

Other Outcomes (3)

  • Incidence of Complications

    From admission to discharge (up to 14 days).

  • Antibiotic Usage Duration

    From admission to discontinuation (up to 14 days).

  • Adherence to Rehabilitation Protocols

    Daily during hospitalization (up to 14 days).

Study Arms (2)

control group

The control group received routine nursing care

Other: control group

observation group

the observation group was additionally managed with an integrated nursing and medical approach.

Other: observation group

Interventions

the observation group was additionally managed with an integrated nursing and medical approach.

observation group

The control group received routine nursing care

control group

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Children's Hospital

Shijiazhuang, 050000, China

Location

Related Publications (1)

  • Hu Y, Guo Q, Liu X, Lv W, Liu L. Integrated nursing and medical management improves outcomes in pediatric lobar pneumonia: a randomized controlled study. Front Pediatr. 2025 Jul 28;13:1612618. doi: 10.3389/fped.2025.1612618. eCollection 2025.

MeSH Terms

Conditions

PneumoniaPersonal Satisfaction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2025

First Posted

April 27, 2025

Study Start

January 13, 2023

Primary Completion

March 20, 2024

Study Completion

October 18, 2024

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations