NCT00775723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
Last Updated

November 3, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

October 17, 2008

Last Update Submit

October 30, 2008

Conditions

Melatonin Production

Keywords

6sulphatoxymelatoninpreterm infantsmelatonin is low in preterm infants at least until the age of 6 months

Eligibility Criteria

Age9 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Related 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. doi: 10.1097/00004703-200212000-00003.

    PMID: 12476070BACKGROUND

  • 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.

    PMID: 18177441BACKGROUND

  • 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. doi: 10.1542/peds.113.4.858.

    PMID: 15060238BACKGROUND

Study Officials

  • Dr Sari Goldstein Ferber

    Sackler School of Medicine, Tel Aviv Universitry

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 3, 2008

Record last verified: 2008-10

Locations

IL(1)