health

1. Student- DR. PRIYANKA GANANI
Guide- DR. SRINIVAS JAKKA
Co Guide- DR. ANAND SUBHASH WANI, DR. TANZILA
Institute: ANKURA HOSPITALS FOR WOMEN AND CHILDREN, KPHB BRANCH, HYDERABAD
THESIS PROTOCOL

2. THESIS TITLE
• Prospective observational study on the clinical profile of children
presenting with complicated pneumonia.

3. Introduction
• Community-acquired pneumonia (CAP) is the leading cause of mortality of under-five children in developing
countries, including India*.
• Annually there are 151.8 million new cases of CAP.
• Based on the burden of CAP, India is among the top five countries and has over 23% of the global cases.
• Community-acquired pneumonia in children can be caused by bacteria and viruses.
*Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and etiology of childhood pneumonia. Bulletin of the world health
organization. 2008 May;86(5):408–16B. pmid:18545744

4.  Although most children with CAP (Community-acquired pneumonia) recover, some children
develop local or systemic complications*.
• Local complications include parapneumonic effusion, empyema, necrotizing pneumonia, and lung
abscess
• Systemic complications include sepsis and septic shock, metastatic infection, multiorgan failure,
acute respiratory distress syndrome, disseminated intravascular coagulation, and death
* de Benedictis FM, Kerem E, Chang AB, Colin AA, Zar HJ, Bush A.
Complicated pneumonia in children. Lancet. 2020 Sep 12;396(10253):786-798. doi: 10.1016/S0140-6736(20)31550-6. PMID:
32919518.
Complicated pneumonia

5. To study the clinical profile of children admitted with complicated
pneumonia in our hospital.
AIM OF THE STUDY

6. OBJECTIVE OF THE STUDY
Primary objective:
The primary objective of this study is to examine the etiology of complicated community-
acquired pneumonia in our patients.
Secondary objectives:
 To identify the spectrum of complications in children admitted with complicated pneumonia.
 To investigate the risk factors associated with the development of complications in these
patients.

7. MATERIAL AND METHODS
Study Setting:
The study will be conducted in Ankura hospital for Women and Children,
Kukatpally, Hyderabad.
Study Duration:
The study will be conducted prospectively for a period of 1 year following
approval by the ethics committee.

8. Study Design:
The study will be conducted by prospective, observational design
Study Sample:
Inclusion criteria:
• Children and adolescents between 1 month and 18 years of age admitted with complicated community-
acquired pneumonia will be included in the study.
Exclusion criteria:
 Complicated pneumonia due to hospital/ventilator-acquired pneumonia.
 Complicated pneumonia in children with underlying lung problems like airway malacia, congenital anomalies
of the lungs, etc.
 Complicated pneumonia due to non-infectious causes like aspiration of food, foreign bodies, hypersensitivity
pneumonitis, etc.

9. Method of Selection:
Participants with complicated pneumonia admitted in wards or PICU will be included in the study.
The diagnosis of community-acquired pneumonia (CAP) is made based on WHO criteria
Pneumonia is defined as the presence of any alveolar or Interstitial opacity in the chest X-rays plus one of the
following symptoms or signs:
• Axillary Fever ≥38.3°C
• Tachypnoea associated with or without chest indrawing in children.
• The presence of rhonchi and or crackles.
Children fulfilling the WHO criteria for pneumonia and developing local or systemic complications will be
included in the study.
The recognized local complications include parapneumonic effusion, empyema, necrosis, and abscess
formation.
The systemic complications include sepsis and septic shock, metastatic infection, multiorgan failure, acute
respiratory distress syndrome, disseminated intravascular coagulation, and death
WHO criteria for tachypnoea
Children 2months: ≥60/min
2 and 11months: ≥50/min
1–4years: ≥40/min
5–12years: ≥30/min
12 years: ≥ 25/min.

10. • These complications will be confirmed using appropriate investigations like Chest X ray, Ultrasound chest,
CT chest, blood cultures etc.
• The etiology will be determined using microbiological investigations like culture and PCR performed on
various samples like sputum, nasopharyngeal/oropharyngeal aspirates, and bronchoalveolar lavage (BAL).
• In patients developing complications, we will aim to identify the known risk factors for developing
complicated pneumonia including age, duration of exclusive breastfeeding, nutritional status, immunization
status, and socio-economic factors (hygiene, household, air pollution)
• We will study the various treatment strategies (conservative, chest drain insertion, intrapleural fibrinolytic,
Video-assisted thoracoscopy or VATS) adopted in the management of patients in our hospital.

11. Intervention:
No specific intervention will be imposed as part of this study. Standard management protocols for complicated
pneumonia in children will be followed.
Data Collection:
Data collection will involve a combination of methods, including a review of medical records, interviews with
caregivers, and clinical assessments.
Relevant clinical and demographic information will be gathered using a structured questionnaire developed
specifically for this study.
Outcome Measures:
Primary outcomes will include understanding the etiology of complicated pneumonia.
Secondary outcomes include understanding the spectrum of complications and risk factors in these patients.

12. Sample Size:
According to a recent study conducted in India, the annual incidence rate of community-acquired pneumonia in
children is reported to be 24%. Out of these 10 to 20% of cases can develop complications. Based on the
above numbers we have calculated a sample size of 41 participants.
Data Management :
Collected data will be carefully recorded, coded, and stored securely to ensure confidentiality and privacy.
Statistical analyses will be conducted using appropriate software, to derive meaningful conclusions from the
study results.
*Awasthi S, Pandey CM, Verma T, Mishra N, Lucknow CAP Group (2019) Incidence of community-acquired pneumonia in children aged 2-59 months of age in Uttar
Pradesh and Bihar, India, in 2016: An indirect estimation. PLoS ONE 14(3): e0214086. https://doi.org/10.1371/journal.pone.0214086

13. Ethical Issues:
• This study will adhere to ethical guidelines and obtain necessary approvals from the Ethics
Committee of Ankura Hospital.
• Informed consent will be obtained from participants or their guardians before enrolling them in the
study.
• Care will be taken to maintain privacy and confidentiality throughout the research process

14. PROFORMA
PATIENT DETAILS
Name
Age
Gender
Location
Date of admission
Date of discharge
MR number
Presenting complaint Yes No Number of days
Cough
Cold
Fever
Difficulty in breathing
Chest pain
Decreased oral intake
Drowsiness/Lethargy
Bluish discolouration
Others (if any)
HISTORY
Name IV/oral with dosage No of days
ANTIBIOTICS RECEIVED BEFORE ADMISSION: NUTRITIONAL HISTORY
Diet Response
Exclusive Breast Feeding
Protein deficit for age
Calorie deficit for age
FAMILY HISTORY:
PAST HISTORY:
Upper class Upper middle Lower middle Upper lower Lower
SOCIO ECONOMIC STATUS (Modified Kuppuswamy scale): VACCINATION HISTORY
Vaccination Yes No Number of doses
BCG
Hib
Pneumococcal
Influenza
HISTORY

15. PROFORMA
VITALS
RESPIRATORY SIGNS:
Anthropometry
EXAMINATION & INVESTIGATION FINDINGS
Heart rate Respiratory rate Saturation at
room air
Temperature CRT Peripheral
pulses
Parameters Actual Expected Percentile
Weight
Height/Length
Mid Arm Circumference
Head Circumference
COLOUR
COLOUR Yes No
Normal
Pale
Cyanosis/dusky
MENTAL STATUS
STATUS Yes No
Normal
Irritable/agitated
lethargic/drowsy
Sign Yes No
Cyanosis
Grunting
Nasal flaring
Chest indrawing/ retractions
Use of accessory muscles of respiration
Tracheal sign (shifted to opposite side)
Vocal fremitus increased
Decreased air entry Left / Right
Wheeze
Crepitations
Bronchial breath sounds
Hb WBC PLATALETS CRP Procal ESR
Findings Details
Infiltrates
Consolidation
Effusion
Necrotic areas
Mediastinal shift
Sample type Test Result
Naso/oropharyngeal aspirate PCR
ET aspirate PCR
Pleural fluid PCR
Pleural fluid Culture
Pleural fluid Gene Xpert
BLOOD INVESTIGATION
CXR FINDINGS
MICROBIOLOGICAL TESTS
USG Findings :
CT Chest findings:

16. LFNC HHFNC CPAP Ventilator
Type of support
No of days
Name IV/oral with dosage No of days
ICD ICD with
fibrinolytic
VATS Others
Type of procedure
No of days
Discharged home DAMA Death
Name IV/oral with dosage No of days
Consolidation with pleural effusion
Consolidation with empyema
Consolidation with necrosis
Lung abscess
Pneumothorax
Systemic complications
Others
RESPIRATORY SUPPORT
ANTIBIOTICS RECEIVED DURING ADMISSION:
PROCEDURES PERFORMED:
FINAL OUTCOME
ANTIBIOTICS ADVISED AFTER ADMISSION:
FINAL DIAGNOSIS
CONCLUSIONS
PROFORMA
MANAGEMENT & DIAGNOSIS

17. REFERENCES
 Child mortality (under 5 years): https://www.who.int/news-room/fact-sheets/detail/levels-and-trends-in-child-under-5-mortality-in-2020
 Pneumonia in children: https://www.who.int/news-room/fact-sheets/detail/pneumonia
 Pneumonia in Children: https://www.stanfordchildrens.org/en/topic/default?id=pneumonia-in-children-90-P02958
 Revised WHO classification and treatment of childhood pneumonia at health facilities. Evidence Summaries, Word Health Organization.
2014. Available at: http://apps.who.int/iris/bitstream/10665/137319/1/9789241507813_eng.pdf. Accessed on 18 Sept 2022
 Ramachandran P, Nedunchelian K, Vengatesan A, Suresh S. Risk factors for mortality in community acquired pneumonia among children
aged 1–59 months admitted in a referral hospital. Indian Pediatr. 2012;49:889–95. doi: 10.1007/s13312-012-0221-3. [PubMed]
[CrossRef] [Google Scholar]
 Tiewsoh K, Lodha R, Pandey RM, Broor S, Kalaivani M, Kabra SK. Factors determining the outcome of children hospitalized with severe
pneumonia. BMC Pediatr. 2009;9:15. doi: 10.1186/1471-2431-9-15. [PMC free article] [PubMed] [CrossRef] [Google Scholar]
 Levine O, O’Brien KL, Deloria-Knoll M, et al. The Pneumonia Aetiology Research For Child Health (PERCH) project: A 21st century
childhood pneumonia aetiology study. Clin Infect Dis. 2012;54:S93–101. doi: 10.1093/cid/cir1052. [PMC free article] [PubMed]
[CrossRef] [Google Scholar]
 Factors determining the outcome of children hospitalized with severe pneumonia: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2651138/

18.  Nascimento-Carvalho CM. Community-acquired pneumonia among children: The latest evidence for an updated management. J Pediatr (Rio J) 2020;96:29–38.
doi: 10.1016/j.jped.2019.08.003. [PMC free article] [PubMed] [CrossRef] [Google Scholar]
 Awasthi S, Rastogi T, Pandey AK, et al. Epidemiology of hypoxic community-acquired pneumonia in children under 5 years of age: an observational study in northern
India. Front Pediatr. 2022;9:790109. doi: 10.3389/fped.2021.790109. [PMC free article] [PubMed] [CrossRef] [Google Scholar]
 Awasthi S, Agarwal G, Singh JV, et al; ICMR-IndiaClen Pneumonia Project Group. Effectiveness of 3-day amoxycillin vs. 5-day co-trimoxazole in the treatment of non-severe
pneumonia in children aged 2-59 months of age: A multi-centric open labelled trial. J Trop Pediatr. 2008;54:382–9. [PubMed]
 Morley D, Torres A, Cillóniz C, Martin-Loeches I. Predictors of treatment failure and clinical stability in patients with community acquired pneumonia. Ann Transl
Med. 2017;5:443. doi: 10.21037/atm.2017.06.54. [PMC free article] [PubMed] [CrossRef] [Google Scholar]
 Standardization of interpretation of chest radiographs for the diagnosis of pneumonia in children. Geneva: WHO. 2001. Available
at: http://apps.who.int/iris/bitstream/10665/66956/1/WHO_V_and_B_01.35.pdf. Accessed on 13 Sept 2022.
 https://www.who.int/news-room/fact-sheets/detail/pneumonia#:~:text=In%20children%20under%205%20years,the%20chest%20expands%20during%20inhalation).
 Nelson text book of paediatrics, 2020, 21st edition
 Wahl B, Knoll MD, Shet A, et al. National, regional and state level pneumonia and severe pneumonia morbidity in children in India: Modelled estimates for 2000 and
2015. Lancet Child Adolesc Health. 2020;4:678–87. doi: 10.1016/S2352-4642(20)30129-2. [PMC free article] [PubMed] [CrossRef] [Google Scholar]
 Local and systemic complication of pneumonia : https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31550-6/fulltext?hss_channel=tw-27013292
 Sample size for complication: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3385228/?report=classic
 Sample size for pneumonia: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0214086

19. THANK YOU