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Melatonin Production Delay in Preterm Infants

NCT ID: NCT00775723

Last Updated: 2008-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melatonin Production

Keywords

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6sulphatoxymelatonin preterm infants melatonin is low in preterm infants at least until the age of 6 months

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

9 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Sackler School of Medicine Tel Aviv University

Principal Investigators

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Dr Sari Goldstein Ferber

Role: STUDY_DIRECTOR

Sackler School of Medicine, Tel Aviv Universitry

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 12476070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18177441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15060238 (View on PubMed)

Other Identifiers

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0

Identifier Type: -

Identifier Source: secondary_id

1673

Identifier Type: -

Identifier Source: org_study_id