PediatricsNCT06945991
Application and Effect Evaluation of Integrated Nursing and Medical Management in Pediatric Lobar Pneumonia
An observational study of Pediatrics and Lobar Pneumonia, run by Children's Hospital of Hebei Province at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pediatrics, Lobar Pneumonia, Inflammatory Markers
- What is being tested?
- observation group
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2023to 18 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pediatrics, Lobar Pneumonia, Inflammatory Markers, Satisfaction
- Being tested
- observation group, control group
- Medical subject headings
- Pneumonia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation groupOther
the observation group was additionally managed with an integrated nursing and medical approach.
control groupOther
The control group received routine nursing care
| Study group | Role | What they receive |
|---|---|---|
| control group | The control group received routine nursing care Receives: Other: control group | |
| observation group | the observation group was additionally managed with an integrated nursing and medical approach. Receives: Other: observation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission until discharge (up to 14 days).
Secondary outcomes (4)
Change in Pulmonary Function (FEV₁, FVC, FEV₁/FVC)
Absolute change in spirometry-measured FEV₁ (L), FVC (L), and FEV₁/FVC ratio (%) from admission to discharge. Assessed using standardized spirometry protocols.
Measured: Baseline (T0) and discharge (T1; up to 14 days).
Reduction in Inflammatory Markers (CRP, PCT, WBC, LDH)
Percent reduction in serum CRP (mg/L), PCT (ng/mL), WBC (×10⁹/L), and LDH (U/L) levels from admission to discharge.
Measured: Baseline (T0) and discharge (T1; up to 14 days).
Length of Hospital Stay
Total days from admission to discharge, documented from electronic health records.
Measured: Up to 14 days.
Parental Satisfaction Rate
Proportion of caregivers reporting "very satisfied" or "satisfied" on a 4-point Likert scale (very satisfied/satisfied/neutral/dissatisfied) at discharge.
Measured: At discharge (T1; up to 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start13 Jan 2023
- Primary completion20 Mar 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PediatricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Hebei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linlin Liu, Children's Hospital of Hebei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945991
- Sponsor's protocol ID
- No. 202222-17
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40791810
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Effect Evaluation of Integrated Nursing and Medical Management in Pediatric Lobar Pneumonia
- ClinicalTrials.gov ID
- NCT06945991
- Acronym / sponsor ID
- No. 202222-17
- Conditions
- Pediatrics, Lobar Pneumonia, Inflammatory Markers, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Hospital of Hebei ProvinceUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: control groupThe control group received routine nursing care |
| observation group | – | Other: observation groupthe observation group was additionally managed with an integrated nursing and medical approach. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation groupthe observation group was additionally managed with an integrated nursing and medical approach. | Other | observation group |
| control groupThe control group received routine nursing care | Other | control group |
Primary outcome
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.
4 secondary outcomes
Change in Pulmonary Function (FEV₁, FVC, FEV₁/FVC)
Time frame: 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).
Length of Hospital Stay
Time frame: Up to 14 days.
Parental Satisfaction Rate
Time frame: At discharge (T1; up to 14 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 40791810Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatrics and Lobar Pneumonia, run by Children's Hospital of Hebei Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Resolution of Symptoms (time frame: From admission until discharge (up to 14 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06945991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.