Melatonin Production Delay in Preterm Infants

Sponsor
Tel Aviv University (Other)
Overall Status
Completed
CT.gov ID
NCT00775723
Collaborator
(none)
46
1
4
11.6

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jan 1, 2008
    Actual Primary Completion Date :
    May 1, 2008
    Actual Study Completion Date :
    May 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      9 Months to 12 Months
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00775723
      Other Study ID Numbers:
      • 1673
      • 0
      First Posted:
      Oct 20, 2008
      Last Update Posted:
      Nov 2, 2008
      Last Verified:
      Oct 1, 2008

      Study Results

      No Results Posted as of Nov 2, 2008