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Melatonin for Neuroprotection Following Perinatal Asphyxia

Primary Purpose

Perinatal Asphyxia

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Melatonin

About this trial

This is an interventional treatment trial for Perinatal Asphyxia focused on measuring HIE, hypothermia, encephalopathy, anti oxidants, MRI

Eligibility Criteria

undefined - 6 Hours (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Tanta University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Healthy Control

Hypothermia Group

Melatonin/ hypothermia group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum melatonin concentration (pg/ ml)

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

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

Secondary Outcome Measures

Incidence of EEG abnormalities

Incidence of MRI abnormalities

Incidence of abnormal neurological examination

Incidence of abnormal Denver Developmental Screening Test II

Full Information

NCT ID

NCT02071160

First Posted

February 23, 2014

Last Updated

February 23, 2014

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT02071160

Brief Title

Melatonin for Neuroprotection Following Perinatal Asphyxia

Official Title

Melatonin for Neuroprotection Following Perinatal Asphyxia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a prospective study on 30 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 15; receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 15; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin, plasma superoxide dismutase (SOD),and serum nitric oxide (NO) are measured at enrollment and after 2 weeks for the two HIE groups. The HIE groups underwent electroencephalography at enrollment and at 2 to 3 weeks. Brain MRI was performed after 2 weeks of life. Neurologic evaluations and Denver Developmental Screening Test II assessments were performed at 6 months. A group of healthy newborns will be used as a control for baseline labs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perinatal Asphyxia

Keywords

HIE, hypothermia, encephalopathy, anti oxidants, MRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Control

Arm Type

No Intervention

Arm Description

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

Arm Title

Hypothermia Group

Arm Type

No Intervention

Arm Description

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

Arm Title

Melatonin/ hypothermia group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Melatonin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Serum melatonin concentration (pg/ ml)

Time Frame

5 days

Title

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

Time Frame

5 days

Title

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

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Incidence of EEG abnormalities

Time Frame

2 weeks

Title

Incidence of MRI abnormalities

Time Frame

2 weeks

Title

Incidence of abnormal neurological examination

Time Frame

6 months

Title

Incidence of abnormal Denver Developmental Screening Test II

Time Frame

6 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heba Mahdy, MD

Organizational Affiliation

Tanta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tanta University Children's Hospital

City

Tanta

State/Province

Gharbeya

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

15168319

Citation

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.

Results Reference

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PubMed Identifier

14966737

Citation

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.

Results Reference

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PubMed Identifier

22370283

Citation

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.

Results Reference

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Melatonin for Neuroprotection Following Perinatal Asphyxia

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