Melatonin Levels in Preterm and Term Newborn Infants

NCT01340417 | Completed

• 2 other identifiers: P0911082010-A01024-35
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

The general goal of the present study is to examine the developmental changes caused by melatonin in preterm and term newborns. The major brain lesions associated with cerebral palsy and cognitive impairment in preterm infants are periventricular white matter damage (WMD). At the present time, despite major improvements in neonatal care, there are no established therapeutic regimens for the treatment of brain lesions in preterms. Melatonin is secreted by the pineal gland; melatonin's neuroprotective action has been well documented in animal experimental models. Neuroprotection is believed to stem from its direct free radical scavenging, indirect antioxidant activities. Originality Several reports have described melatonin secretion in older children, but only a few have observed melatonin concentrations during the first year of life. Very little is known about the fetal pineal melatonin synthesis and nothing at what prenatal age melatonin synthesis starts. Premature infants have a 3 months delay in the development of melatonin rhythmicity compared to full-term infants. One study found discordant data with decreasing melatonin value around term. The absence of longitudinal study and the low number of children included make the interpretation difficult of the secretion of melatonin at the newborn. Hypothesis: Infants born before 28 weeks gestation have melatonin deficiency (50pg/ml), compared to newborns at term (100pg/ml). Study design: prospective, longitudinal, multicenter trial in 3 Neonatal Intensive Care Units in Ile de France. Specific aim is to compare the developmental changes of melatonin in preterm and term newborns (200 infants and their mothers: 4 groups of 50 infants: 24-27GA +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following:

• determine Melatonin creatinin excretion in preterm infants
• correlate between serum melatonin secretion and urinary melatonin and 6-sulfatoxymelatonin excretion
• determine endogenous melatonin production in the human pineal
• correlate genetic variations between different levels of melatonin in premature infants
• assess clinical and neurological outcomes at term Clinical impact The present clinical project is part of a translational approach, expected data for infants born before 28 weeks gestation is melatonin deficiency which should participate in determining the potential use of melatonin as a neuroprotectant in human preterm neonates.

Conditions

Pregnancy Preterm

Keywords

melatonin; preterm; deficiency; neuroprotection

Outcome Measures

Primary Outcomes (2)

• Measurements of melatonin levels by radioimmunology

  Primary outcomes are measurements of melatonin levels in urine, blood, milk. These procedures will be made by radioimmunology, to limit data variability. The reasoning will be made in coefficient of variation intra-test for a patient.

  3 days if delivery between 34 and 41+6d weeks of gestation

• Measurements of melatonin levels by radioimmunology

  Primary outcomes are measurements of melatonin levels in urine, blood, milk. These procedures will be made by radioimmunology, to limit data variability. The reasoning will be made in coefficient of variation intra-test for a patient.

  15 days to 3 months if delivery between 24 and 33+6d weeks of gestation

Secondary Outcomes (4)

• Serum Cortisol concentrations and urinary excretion

  3 days if delivery between 34 and 41+6d weeks of gestation

• Serum Cortisol concentrations and urinary excretion

  15 days to 3 months if delivery between 24 and 33+6d weeks of gestation

• Serum Serotonin level

  3 days if delivery between 34 and 41+6d weeks of gestation

• Serum Serotonin level

  15 days to 3 months if delivery between 24 and 33+6d weeks of gestation

Study Arms (1)

one label

EXPERIMENTAL

Measurements of melatonin levels in urine, blood, milk.

Other: Measurements of melatonin levels in urine, blood, milk.

Interventions

Measurements of melatonin levels in urine, blood, milk. OTHER

Measurements of melatonin levels in urine, blood, milk.

one label

Eligibility Criteria

• Age: 24 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mother:
• Consent forms from mother or guardian
• Age ≥ 18 years
• Mother Heath insurance
• Newborn:
• Infants born between 24+0 et 41+6 weeks of gestation
• Infants with informed consent from mother or guardian and mother's social insurance

You may not qualify if:

• Mother:
• Chronic pathology
• Treatment: Carbamazepine, betablockers, rifampicin, quinolones, cimetidine, 5-Methoxypsoralen or bergapten, 8- methoxypsoralen (or Methoxsalen), CIRCADIN®
• Newborn :
• Congenital malformations
• Dermatosis
• Treatment: cimetidine

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Robert DEBRE

Paris, 75019, France

Location

Related Publications (1)

• Biran V, Decobert F, Bednarek N, Boizeau P, Benoist JF, Claustrat B, Barre J, Colella M, Frerot A, Garnotel R, Graesslin O, Haddad B, Launay JM, Schmitz T, Schroedt J, Virlouvet AL, Guilmin-Crepon S, Yacoubi A, Jacqz-Aigrain E, Gressens P, Alberti C, Baud O. Melatonin Levels in Preterm and Term Infants and Their Mothers. Int J Mol Sci. 2019 Apr 27;20(9):2077. doi: 10.3390/ijms20092077.

  PMID: 31035572 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Urination; Blood Specimen Collection; Milk

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Valérie BIRAN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 22, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 3, 2023

Record last verified: 2013-09

Locations

FR (1)