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

NCT07442162 | Enrolling By Invitation Phase 1

• 2 other identifiers: Melatonin-neonates-01melatonin-neonates-01
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Crying

Keywords

melatonin, excessive crying

Outcome Measures

Primary Outcomes (2)

• effects of melatonin on the duration of crying in neonates

  the daily mean crying times between the group using melatonin and that of placebo (multivitamin drops) group

  28 days

• effect of melatonin on the mean time of daily duration of crying in minutes

  two groups of neonates group of using oral melatonin 83 neonates versus group of placebo multivitamin 82 neonates and comparison of mean time duration in minutes between the two groups

  28 days

Study Arms (2)

melatonin group

ACTIVE COMPARATOR

group

Drug: one group of neonates with excessive crying receive melatonin orally n=83

placebo group

PLACEBO COMPARATOR

group of the placebo 82 neonates with excessive crying but receiving placebo

Drug: use of multivitamin

Interventions

use of multivitamin DRUG

melatonin used to calm the babies who suffer from infantile colic

placebo group

one group of neonates with excessive crying receive melatonin orally n=83 DRUG

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.

melatonin group

Eligibility Criteria

• Age: 14 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Al-Hadba university: lead

Study Sites (1)

Al-hadba university

Mosul, Nineveh Governorate, 41, Iraq

Location

Related Publications (1)

• 1. Wessel MA, Cobb JC, Jackson EB, Harris GS, Detwiler AC (1954) Paroxysmal fussing in infancy, sometimes called colic. Pediatrics 14(5):421-435. 2. Barr RG (2017) Excessive crying. In: Textbook of Pediatric Care. American Academy of Pediatrics. 3. Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ (2001) Systematic review of the occurrence of infantile colic in the community. Arch Dis Child 84(5):398-403. 4. Clinical Practice Guidelines: Unsettled or crying babies. Royal Children's Hospital Melbourne. 2023. 5. Reijneveld SA, van der Wal MF, Brugman E, Hira Sing RA, Verloove-Vanhorick SP(2004) Infant crying and abuse. Lancet 364(9442):1340-1342. 6. Barr RG, Rotman A, Yaremko J, Leduc D, Francoeur TE (1992) The crying of infants with colic: a controlled empirical description. Pediatrics 90(1):14-21. 7. Savino F(2007) Focus on infantile colic. Acta Paediatr 96(9):1259-1264. 8. Sung V, Hiscock H, Tang ML et al (2014) Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomized trial. BMJ 348:g2107. 9. D'Agata AL, Baldwin N, Brownell EA, Badr MS, St John NH (2019) Infant crying: Impact of prematurity and perinatal stress. Early Hum Dev135:33-39 10. Akhnikh S, Engelberts A. C, van Sleuwen B. E, L'Hoir, M. P, & Benninga M. A (2014). The excessively crying infant: Etiology and treatment. Pediatric Annals 43(4), e69-e75. 11. Shakiba M, Momayezolashjar M, Hassani Kaboutarkhani M (2022) Investigating the effect of melatonin on infantile colic: A clinical trial. Pharmacognosy Reviews 13(S09):1142. 12. Paditz E (2024) Postnatal development of circadian rhythmicity of human pineal melatonin synthesis. Children11(10):1197. 13. Aversa S, Marseglia L, Arco A et al (2012) Efficacy and safety of melatonin in neonates. Arch Dis Child 97(Suppl 2): A464. 14. İnce T, Akman H, Çimrin D, Aydın A(2018) Role of melatonin and cortisol circadian rhythms in infantile colic. World J Pediatr14:392-398. 15. Paditz E (2024)

  RESULT

Related Links

• use of melatonin drops orally to treat excessive crying in neonates

MeSH Terms

Conditions

Crying

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the author is also masked as double-blinded randomized study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Consultant Pediatrician

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: February 23, 2026
• Primary Completion: March 28, 2026
• Study Completion: April 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

IR (1)