Efficacy of melatonin on nocturnal irritability
Phase 2
Recruiting
- Conditions
- idiopathic nocturnal irritability.Nonspecific symptoms peculiar to infancyR68.1
- Registration Number
- IRCT20090808002306N8
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Infant aged 6-24 months with a clinical diagnosis of idiopathic nocturnal irritability without underlying cause (19th edition of Nelson's comprehensive textbook of pediatric diseases) by a pediatrician
Absence of organic presence for irritability/insomnia at night
Not taking other drugs for irritability/sleeplessness at night
Consent and informed consent of children's parents to enter this research plan
Exclusion Criteria
The request of the child's parents to leave
Occurrence of any type of allergic complication related to the drug
Failure to comply with treatment for more than 4 nights a week and for two consecutive weeks
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life of infants with nocturnal irritability. Timepoint: At the beginning of the study and 2 weeks later. Method of measurement: Brief Infant Sleep Questionnaire (BISQ).
- Secondary Outcome Measures
Name Time Method . Timepoint: . Method of measurement: .