PneumoniaNCT06583317
Recurrent Pneumonia in Children
An observational study of Pneumonia and Lower Respiratory Tract Infection, run by Assiut University.
Trial summary
This study aimed to analyses the clinical characteristics, risk factors and underlying causes as predictors of recurrent pneumonia in children attending AUCH Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Pneumonia, Lower Respiratory Tract Infection, Chest Infection
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to Jan 2026
- 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 30 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with recurrent pneumonia
Who may be able to join
- • All children more than 1 month and less than 18 years of age
- All cases presented by picture of recurrent pneumonia in the form of as at least two episodes of pneumonia in one year or three episodes ever, with radiographic clearing of densities in between.
Who cannot join
- • All children less than 1 month and more than 18 years
- Evidence of malignancies
- Evidence of congenital immune deficiency
- Cases refusing to participate in research.
- Cases missed for follow up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Recurrent Pneumonia in Children at Assiut University Children's Hospital
This study aimed to analyses the clinical characteristics, risk factors and underlying causes as predictors of recurrent pneumonia in children attending AUCH
Read the detailed description
Pneumonia is defined as inflammation of lung parenchyma due to various pathogenic organisms including bacteria, viruses, fungi and parasites. The key symptom to suspect childhood pneumonia is tachypnea. The World Health Organization (WHO) has defined tachypnea as respiratory rate >60 breaths/min in infants less than 2 months, >50 in infants 2 -12 months and >40 in children 1 to 5 years and >20 in children >5 years of age [1]. WHO has categorized pneumonia in children under-five years of age into two categories, pneumonia and severe pneumonia. Tachypnea with or without chest retraction is categorized as pneumonia while tachypnea with any danger signs (unable to feed or drink, hypothermia, unconsciousness, convulsion, signs of hypoxia including cyanosis, grunting, groaning, head nodding) as severe pneumonia [1].
Pneumonia is a common and described as the overlooked killer of children[2] as killing 1.1-1.4 million children every year. It accounts for 17%-19% of all deaths amongst children under 5 years of age; the majority of them are in developing countries [3,4] .In Egypt, children under 5 years approximate 13.4% of the total population[4] and pneumonia constitutes 19% of under-five mortality[5].
Recurrent pneumonia (RP) is defined as at least two episodes of pneumonia in one year or three episodes ever, with intercritical radiographic clearing of densities [6]. Incidence data indicate that RP occurs in 7.7%-9% of all children with CAP [7,8,9,10,11,12]. As a result, RP represents a frequent presenting manifestation in the general pediatric practice and is a very common reason for referral to pediatric chest physicians [7]. Factors linked to these infections could be recurrent aspirations, congenital structural anomalies of pulmonary and cardiovascular systems, defects in the clearance of airway secretions and immunodeficiency [13]
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
To delineate risk factors of recurrent chest infection.
Characteristics of studied children in AUCH as in feeding, nutritional status and growth parameters.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Abdelnaser Marouf Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583317
- Sponsor's protocol ID
- pnemonia
- Status last verified
- Aug 2024
- First submitted
- 1 Sep 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
PubMed 23369797Bhutta ZA, Das JK, Walker N, Rizvi A, Campbell H, Rudan I, Black RE; Lancet Diarrhoea and Pneumonia Interventions Study Group. Interventions to address deaths from childhood pneumonia and diarrhoea equitably: what works and at what cost? Lancet. 2013 Apr 20;381(9875):1417-1429. doi: 10.1016/S0140-6736(13)60648-0. Epub 2013 Apr 12.
PubMed 23582723
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Pneumonia in Children at Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT06583317
- Acronym / sponsor ID
- pnemonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Sep 2024 (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.
This study aimed to analyses the clinical characteristics, risk factors and underlying causes as predictors of recurrent pneumonia in children attending AUCH
Detailed description
Pneumonia is defined as inflammation of lung parenchyma due to various pathogenic organisms including bacteria, viruses, fungi and parasites. The key symptom to suspect childhood pneumonia is tachypnea. The World Health Organization (WHO) has defined tachypnea as respiratory rate >60 breaths/min in infants less than 2 months, >50 in infants 2 -12 months and >40 in children 1 to 5 years and >20 in children >5 years of age [1]. WHO has categorized pneumonia in children under-five years of age into two categories, pneumonia and severe pneumonia. Tachypnea with or without chest retraction is categorized as pneumonia while tachypnea with any danger signs (unable to feed or drink, hypothermia, unconsciousness, convulsion, signs of hypoxia including cyanosis, grunting, groaning, head nodding) as severe pneumonia [1].
Pneumonia is a common and described as the overlooked killer of children[2] as killing 1.1-1.4 million children every year. It accounts for 17%-19% of all deaths amongst children under 5 years of age; the majority of them are in developing countries [3,4] .In Egypt, children under 5 years approximate 13.4% of the total population[4] and pneumonia constitutes 19% of under-five mortality[5].
Recurrent pneumonia (RP) is defined as at least two episodes of pneumonia in one year or three episodes ever, with intercritical radiographic clearing of densities [6]. Incidence data indicate that RP occurs in 7.7%-9% of all children with CAP [7,8,9,10,11,12]. As a result, RP represents a frequent presenting manifestation in the general pediatric practice and is a very common reason for referral to pediatric chest physicians [7]. Factors linked to these infections could be recurrent aspirations, congenital structural anomalies of pulmonary and cardiovascular systems, defects in the clearance of airway secretions and immunodeficiency [13]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with recurrent pneumonia
Key inclusion criteria (2 listed)
- • All children more than 1 month and less than 18 years of age
Key exclusion criteria (5 listed)
- • All children less than 1 month and more than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To delineate risk factors of recurrent chest infection.
Time frame: Baseline
Characteristics of studied children in AUCH as in feeding, nutritional status and growth parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Results publication: PubMed 23369797Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
- Results publication: PubMed 23582723Bhutta ZA, Das JK, Walker N, Rizvi A, Campbell H, Rudan I, Black RE; Lancet Diarrhoea and Pneumonia Interventions Study Group. Interventions to address deaths from childhood pneumonia and diarrhoea equitably: what works and at what cost? Lancet. 2013 Apr 20;381(9875):1417-1429. doi: 10.1016/S0140-6736(13)60648-0. Epub 2013 Apr 12.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Lower Respiratory Tract Infection, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Abdelnaser Marouf, Bachelor of Medicine (01093573433, daliamarof291@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To delineate risk factors of recurrent chest infection. (time frame: Baseline). 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 NCT06583317, which also lists 2 linked publications.
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 4 Sep 2024.