idiopathic nocturnal irritability. Nonspecific symptoms peculiar to infancy
Conditions
Interventions
Intervention 1: Intervention group: consumption of melatonin with a dose of 0.1 mg/kg formulated as an oral product suitable for infants (probably a suspension) with a concentration of 1 mg/ml in this
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Months to 24 Months
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| . Timepoint: . Method of measurement: . | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Mohammed Sabzeghabaiei
Esfahan University of Medical Sciences
Outcome results
None listed