Effects of Melatonin on Excessive Crying in Neonates. A Randomized Controlled Clinical Trial.

Plain-language summary

the goal of this clinical trial is to learn if melatonin could reduce the duration of excessive crying and infantile colic in neonates and if this drug can be an option to be used in treating such problem- infantile colic and crying which creates anxiety to the parents, and to assess the safety of using melatonin in neonates. the author invited 165 mothers of 165 neonates having excessive crying more than 3 hours per day over 3 days per week, with ages ranged from 14-20 days with 4 categories of neonates according to the status of delivery: Cesarean section, Difficult labor, premature delivery, Small for gestational Age (IUGR) babies, as well as normal delivery neonates. these neonates will be randomly assigned into group Of melatonin 82 neonates, and 83 neonates will receive oral multivitamins as placebo that was made comparable to melatonin in taste and viscosity and color by the research pharmacy in Mosul, the dose of Melatonin will be 0.1mg/kg/12 hourly ,given daily up to 28 days of the start of administration of both melatonin and multivitamin. randomization is performed using opaque sealed envelopes which are sequentially numbered from 1-178 and allocation is concealed from mothers and the author. the clinic nurse will be the responsible for distribution of allocations. The mother will be instructed to record the daily duration of crying in minutes and report these values by telephone follow up throughout the study. The study design is a double-blinded randomized clinical trial. the whole study is to be conducted in a pediatric clinic prospectively. the group of neonates with melatonin will be compared with the group of neonates receiving multivitamins as placebo in the mean-crying times using t-tests

Who can participate

What they're measuring

Trial details