NCT02071160

Brief Summary

The aim of this study is to examine the effect of combining melatonin to whole body cooling on the brain injury and outcome of neonates following perinatal asphyxia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2012

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, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

February 23, 2014

Last Update Submit

February 23, 2014

Conditions

Perinatal Asphyxia

Keywords

HIEhypothermiaencephalopathyanti oxidantsMRI

Outcome Measures

Primary Outcomes (3)

  • Serum melatonin concentration (pg/ ml)

    5 days

  • Plasma superoxide dismutase (SOD) activity (U/ml)

    5 days

  • Serum nitric oxide (NO) concentrations (µmol/L)

    5 days

Secondary Outcomes (4)

  • Incidence of EEG abnormalities

    2 weeks

  • Incidence of MRI abnormalities

    2 weeks

  • Incidence of abnormal neurological examination

    6 months

  • Incidence of abnormal Denver Developmental Screening Test II

    6 months

Study Arms (3)

Healthy Control

NO INTERVENTION

A group of healthy control without any history suggestive of perinatal asphyxia or other diseases, are enrolled to compare different laboratory measurements

Hypothermia Group

NO INTERVENTION

HIE infants who will not receive melatonin and only receive routine cooling protocol.

Melatonin/ hypothermia group

EXPERIMENTAL

HIE infants who will receive melatonin in addition to the routine cooling protocol

Drug: Melatonin

Interventions

MelatoninDRUG

Melatonin is administered to the melatonin/hypothermia group (n=15) in a dose of 10 mg/kg daily for a total of 5 doses starting immediately at enrollment. Melatonin tablets (1 or 3 mg/tablet) (Puritan's Pride,Oakdale, NY, USA) are crushed, then dissolved in 5-10 ml of distilled water , then administered via an orogastric tube.

Melatonin/ hypothermia group

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Inborn infants at term gestation (38-42 weeks)
  • Apgar scores ≤ 3 at 5 minutes and/or delayed first breath (\>5 minutes after birth)
  • Profound metabolic or mixed acidosis with serum bicarbonate levels of \<12 mmol/L in initial blood gas analyses
  • Evidence of moderate or moderate to severe encephalopathy, such as lethargy, seizures, abnormal reflexes, or hypotonia, in the immediate neonatal period

You may not qualify if:

  • Twin gestation
  • Maternal neuro-endocrinal disturbances including diabetes mellitus
  • Chorioamnionitis or congenital infections
  • Low birth weight less than 2.5 kg
  • Congenital malformations of the central nervous system or gastrointestinal anomalies
  • Chromosomal abnormalities
  • After 6 hours of birth.
  • Patients in extremis such as: (1) hypoxemia requiring supplemental oxygen 100% FiO2, (2) life threatening coagulopathy, or (3) deep coma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Children's Hospital

Tanta, Gharbia Governorate, Egypt

Location

Related Publications (3)

  • Gitto E, Reiter RJ, Cordaro SP, La Rosa M, Chiurazzi P, Trimarchi G, Gitto P, Calabro MP, Barberi I. Oxidative and inflammatory parameters in respiratory distress syndrome of preterm newborns: beneficial effects of melatonin. Am J Perinatol. 2004 May;21(4):209-16. doi: 10.1055/s-2004-828610.

    PMID: 15168319BACKGROUND

  • Gitto E, Romeo C, Reiter RJ, Impellizzeri P, Pesce S, Basile M, Antonuccio P, Trimarchi G, Gentile C, Barberi I, Zuccarello B. Melatonin reduces oxidative stress in surgical neonates. J Pediatr Surg. 2004 Feb;39(2):184-9; discussion 184-9. doi: 10.1016/j.jpedsurg.2003.10.003.

    PMID: 14966737BACKGROUND

  • Chen YC, Tain YL, Sheen JM, Huang LT. Melatonin utility in neonates and children. J Formos Med Assoc. 2012 Feb;111(2):57-66. doi: 10.1016/j.jfma.2011.11.024. Epub 2012 Feb 15.

    PMID: 22370283BACKGROUND

MeSH Terms

Conditions

HypothermiaBrain Diseases

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Heba Mahdy, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

February 23, 2014

First Posted

February 25, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

EG(1)