NCT00775723

Melatonin Production Delay in Preterm Infants

Term-Born Infants at 9 and 12 Months of Age: A Randomized Controlled Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Tel Aviv University · Academic / Other
• Sex: All
• Age: 9 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months of age. This might be related to exposure of preterm infants to continuous lighting in the NICU during a critical period of pineal gland development. The investigators aimed to test the profile of melatonin production in these infants at 9-12 months of age. Methods: Twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks) were studied. The investigators tested nocturnal urinary melatonin excretion, within a repeated measures design, both at 9 and 12 months of age. Nocturnal urine was extracted from diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by ELISA assay.

Detailed description

Unlike other organs which show catch up in preterm infants after one year of life, the pineal gland shows persistent delay in melatonin production. This field of research has been neglected lately although there are published recommendations for decrease of bright light in NICUs which prevents melatonin development and production, and also recommendations for melatonin treatment in cases respiration recovery in hospitalized preterm infants.

Conditions

• Melatonin Production

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-10-20
• Last updated: 2008-11-03

Locations

1 site across 1 country: Israel