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Melatonin Production Delay in Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
Tel Aviv University
ClinicalTrials.gov Identifier:
NCT00775723
First received: October 17, 2008
Last updated: October 30, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Phase
Melatonin Production
 Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Term-Born Infants at 9 and 12 Months of Age: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Tel Aviv University:

Enrollment: 46
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   9 Months to 12 Months
Genders Eligible for Study:   Both
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).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775723

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

Publications:

Responsible Party: Dr Sari Goldstein Ferber, Director of Developmental Care, Sackler School of Medicine Tel Aviv University
ClinicalTrials.gov Identifier: NCT00775723     History of Changes
Other Study ID Numbers: 1673, 0
Study First Received: October 17, 2008
Last Updated: October 30, 2008
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 17, 2013