Melatonin Production Delay in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00775723
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : November 3, 2008
Information provided by:
Tel Aviv University

Brief 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.

Condition or disease
Melatonin Production

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.

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Term-Born Infants at 9 and 12 Months of Age: A Randomized Controlled Trial
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   9 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Design: Forty-six infants (23 full term and 23 preterm babies) infants and their mothers were randomly recruited from a successive list of preterm and term labors at a large urban medical center in Northern Israel and were assigned to the study. We calculated that a sample size of 30 mother-infant dyads is sufficient to show a significant effect of the intervention with a power of 90% and 5% risk of type alpha error (Cohen , chen, West & Aiken, 2003). This calculation was based on the effect size found in full-term infants melatonin secetion (1).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00775723

Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Tel Aviv University
Study Director: Dr Sari Goldstein Ferber Sackler School of Medicine, Tel Aviv Universitry

Responsible Party: Dr Sari Goldstein Ferber, Director of Developmental Care, Sackler School of Medicine Tel Aviv University Identifier: NCT00775723     History of Changes
Other Study ID Numbers: 1673
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: November 3, 2008
Last Verified: October 2008

Keywords provided by Tel Aviv University:
preterm infants
melatonin is low in preterm infants at least until the age of 6 months

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants