Melatonin Production Delay in Preterm Infants

Melatonin Production Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775723
• Other study ID #: 1673
• Secondary ID: 0
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 17, 2008
• Last updated: October 30, 2008
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: October 2008
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 12 Months

Eligibility

Inclusion Criteria:

• The investigators included healthy mothers with singleton pregnancies and documented prenatal care who were admitted before term (28-34) weeks gestation to the hospital's delivery room with early uterine contractions and entering stage 1 of an anticipated spontaneous vaginal delivery or term infants born at 38-42 weeks of gestation.

Exclusion criteria:

• Mothers who showed signs of fetal distress during labor, or required Cesarean (C)c-section, or had fetuses withand estimated fetal weights < 10th percentile for gestational age and children diagnosed with

• Genetic anomalies, congenital heart malformations, gastrointestinal disturbances and central nervous system dysfunction

• Age < 9 months, Age > 9 months month at onset of study

• Considered medically unstable

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melatonin Production

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Ferber SG, Laudon M, Kuint J, Weller A, Zisapel N. Massage therapy by mothers enhances the adjustment of circadian rhythms to the nocturnal period in full-term infants. J Dev Behav Pediatr. 2002 Dec;23(6):410-5. — View Citation

Ferber SG, Makhoul IR. Neurobehavioural assessment of skin-to-skin effects on reaction to pain in preterm infants: a randomized, controlled within-subject trial. Acta Paediatr. 2008 Feb;97(2):171-6. doi: 10.1111/j.1651-2227.2007.00607.x. Epub 2008 Jan 3. — View Citation

Ferber SG, Makhoul IR. The effect of skin-to-skin contact (kangaroo care) shortly after birth on the neurobehavioral responses of the term newborn: a randomized, controlled trial. Pediatrics. 2004 Apr;113(4):858-65. — View Citation