OPERATIONAL DEFINITION:
Pneumonia: defined as patient having fast breathing;
Severe Pneumonia: defined as patient having cough or difficulty in breathing with:
Oxygen saturation < 90% or central cyanosis Severe respiratory distress (e.g. grunting,
very severe chest in-drawing) Signs of pneumonia with a general danger sign (inability to
breastfeed or drink, lethargy or reduced level of consciousness, convulsions) Length of
Hospital Stay: measured in days from the day of admission to the day of discharge for
both groups.
Discharge Criteria: Discharge criteria for children who have been admitted to the
hospital include:
Improvement of vital signs Ability to maintain adequate fluid and nutrition orally
Ability to maintain oxygen saturation ≥90 percent in room air Overall clinical
improvement including level of activity, appetite, and decreased fever
OPERATIONAL DEFINTION:
Pneumonia: defined as patient having fast breathing;
Severe Pneumonia: defined as patient having cough or difficulty in breathing with:
Oxygen saturation < 90% or central cyanosis Severe respiratory distress (e.g. grunting,
very severe chest in-drawing) Signs of pneumonia with a general danger sign (inability to
breastfeed or drink, lethargy or reduced level of consciousness, convulsions) Length of
Hospital Stay: measured in days from the day of admission to the day of discharge for
both groups.
Discharge Criteria: Discharge criteria for children who have been admitted to the
hospital include:
Improvement of vital signs Ability to maintain adequate fluid and nutrition orally
Ability to maintain oxygen saturation ≥90 percent in room air Overall clinical
improvement including level of activity, appetite, and decreased fever
RESEARCH METHODOLOGY:
Study design: Randomized Controlled Clinical Trial (RCT) Setting: It will be conducted at
Children Hospital, Pakistan Institute of Medical Sciences (PIMS), Islamabad, Pakistan.
Study duration: Approx. 6 months after approval of synopsis. Sample size: Sample size is
calculated based on a previous study on the same topic by using WHO sample size
calculator; 60 in total having 30 in each group with level of significance 5%, power of
test 80%. The median hospital discharge time was 15 days (range: 13-17) for the melatonin
group and 21 days (range: 14-24) for the control group (9).
Sampling technique: Consecutive sampling
DATA COLLECTION PROCEDURE:
Prior to the study, healthcare professionals working in emergency departments/outpatient
clinics will receive training on their respective roles, responsibilities and study
protocols. The clinician will identify eligible patients and provide them with written
and verbal information about the study. The parent/legal guardian of the patient will
provide informed consent while the patient will provide informed assent if appropriate.
After obtaining consent, the patients will be randomized. The control group will receive
standard treatment (antibiotic such as ampicillin at a dose of 150mg/kg/day divided every
8 hours), while the intervention group will receive standard treatment plus melatonin for
14 days at the dose of 1 mg/dose in infants and 2.5 to 3mg/dose in children three times a
day for 14 days. The patients who will not take more than 10% of the medication will be
excluded from the study. The follow-up period will be 2 weeks for all patients.
DATA ANALYSIS PROCEDURE:
Once data collection is complete, the questionnaires will be checked for completeness and
consistency by the data collectors. The normality distribution of variables will be
evaluated using the Kolmogorov-Smirnov test. Qualitative variables (Gender, socioeconomic
status and symptoms (fever, cough, breathing difficulty, decreased oral intake, fits,
level of consciousness and persistent vomiting, pneumonia and severe pneumonia)) will be
presented as frequencies and percentages (%). Quantitative variables (Age, weight, heart
rate, respiratory rate, blood pressure, temperature, oxygen saturation, laboratory
parameters (total leukocyte count, hemoglobin, neutrophils, lymphocytes, platelets,
C-reactive protein, pH, PCO, P02, HCO3) and length of hospital stay) will be presented as
mean ± standard deviation (SD). Both groups (melatonin and non-melatonin) will be
compared for length of hospital stay by using independent sample t-test. Effect modifiers
like age, gender, socioeconomic status, weight, and pneumonia/ severe pneumonia will be
stratified using post stratified independent sample t-test. Statistical analyses will be
conducted using SPSS software version 25.0, with a significance level of p-value <0.05.