Actively Recruiting

Phase 1
Phase 2
Age: 1Month - 12Years
All Genders
ID06949904

The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia

Led by Mian Muhammad Hassan Ahmed · Updated on 2025-04-29

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of adding melatonin to standard treatment for children aged 1 month to 12 years diagnosed with pneumonia or severe pneumonia. The goal is to see if combining oral melatonin with antibiotics can reduce the length of hospital stay compared to standard care alone. The study is a randomized controlled trial conducted to compare these two approaches in a hospital setting. Participants will be randomly assigned to one of two groups. The control group will receive standard antibiotic treatment, such as ampicillin at 150 mg/kg/day divided every 8 hours. The intervention group will receive the same antibiotic treatment plus melatonin—dosed at 1 mg per dose for infants and 2.5 to 3 mg per dose for children—taken three times daily for 14 days. Medication adherence is monitored, and patients who take less than 90% of the medication will be excluded. During the study, children will be closely monitored from admission until discharge, with hospital stay length being the main outcome measured. Discharge depends on improvement in vital signs, oxygen saturation of at least 90% on room air, ability to maintain nutrition orally, and overall clinical improvement. Data collected will include vital signs, breathing rates, laboratory tests, and symptom assessments. The follow-up period lasts 2 weeks after treatment. Statistical analysis will compare hospital stay lengths between groups to assess the impact of melatonin as an adjunct therapy.

CONDITIONS

Brief Title

The Role of Melatonin as an Adjuvant Therapy in Childhood Pneumonia

Who Can Participate

Age: 1Month - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 1 month and 12 years
  • Both genders
  • Diagnosed with pneumonia or severe pneumonia according to WHO definition
Not Eligible

You will not qualify if you...

  • Hospitalized within 14 days prior to the study
  • Known tuberculosis exposure
  • Active varicella or herpes simplex infection
  • Allergy to melatonin or study medication
  • Currently taking melatonin
  • Any acute illness requiring antibiotics other than pneumonia
  • Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
  • Significant co-morbid diseases affecting lungs, heart, immune system, liver, endocrine, neurological or psychiatric health

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 14 days

Participants receive standard antibiotic treatment, with the experimental group also receiving melatonin three times a day for 14 days.

Daily monitoring during hospital stay

Follow-up

Duration - 2 weeks

Participants are followed for 2 weeks after treatment to monitor recovery and treatment outcomes.

Follow-up visits during the 2-week post-treatment period

Trial Site Locations

Total: 1 location

1

Pakistan Institute of Medical Sciences

Islamabad, Islamabad, Pakistan, 44000

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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