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Effects of Melatonin on Excessive Crying in Neonates. A Randomized Controlled Clinical Trial.
Sponsor: Al-Hadba university
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
Official title: Effect Of Melatonin on Excessive Crying in Neonates. a Randomized Clinical Trial
Key Details
Gender
All
Age Range
14 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
165
Start Date
2026-02-23
Completion Date
2026-04-01
Last Updated
2026-03-02
Healthy Volunteers
Yes
Conditions
Interventions
use of multivitamin
melatonin used to calm the babies who suffer from infantile colic
one group of neonates with excessive crying receive melatonin orally n=83
two groups of neonates with excessive crying , group of melatonin oral drop , compared with the group of placebo (multivitamin oral drops) to find out the effect of melatonin on excessive crying status and comparing it with the effect of placebo on the excessive crying of the placebo(multivitamin drop orally),as to verify the effect of melatonin as an option to be used for infantile colic. the study is conducted in double-blinded. randomization.
Locations (1)
Al-hadba university
Mosul, Nineveh Governorate, Iraq