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Melatonin for Neuroprotection Following Perinatal Asphyxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02071160
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Heba Mahdy, Tanta University

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.

Condition or disease Intervention/treatment Phase
Perinatal Asphyxia Drug: Melatonin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin for Neuroprotection Following Perinatal Asphyxia
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
No Intervention: Healthy Control
A group of healthy control without any history suggestive of perinatal asphyxia or other diseases, are enrolled to compare different laboratory measurements
No Intervention: Hypothermia Group
HIE infants who will not receive melatonin and only receive routine cooling protocol.
Experimental: Melatonin/ hypothermia group
HIE infants who will receive melatonin in addition to the routine cooling protocol
Drug: Melatonin
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 Measures :
  1. Serum melatonin concentration (pg/ ml) [ Time Frame: 5 days ]
  2. Plasma superoxide dismutase (SOD) activity (U/ml) [ Time Frame: 5 days ]
  3. Serum nitric oxide (NO) concentrations (µmol/L) [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Incidence of EEG abnormalities [ Time Frame: 2 weeks ]
  2. Incidence of MRI abnormalities [ Time Frame: 2 weeks ]
  3. Incidence of abnormal neurological examination [ Time Frame: 6 months ]
  4. Incidence of abnormal Denver Developmental Screening Test II [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02071160

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Tanta University Children's Hospital
Tanta, Gharbeya, Egypt
Sponsors and Collaborators
Tanta University
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Principal Investigator: Heba Mahdy, MD Tanta University
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Responsible Party: Heba Mahdy, Assistant Professor of Pediatrics, Tanta University Identifier: NCT02071160    
Other Study ID Numbers: 01012012
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014
Keywords provided by Heba Mahdy, Tanta University:
anti oxidants
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants