Perinatal Asphyxia Clinical Trial
Official title:
Melatonin for Neuroprotection Following Perinatal Asphyxia
Verified date | February 2014 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 6 Hours |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University Children's Hospital | Tanta | Gharbeya |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
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. Review. — View Citation
Gitto E, Reiter RJ, Cordaro SP, La Rosa M, Chiurazzi P, Trimarchi G, Gitto P, Calabrò 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum melatonin concentration (pg/ ml) | 5 days | No | |
Primary | Plasma superoxide dismutase (SOD) activity (U/ml) | 5 days | No | |
Primary | Serum nitric oxide (NO) concentrations (µmol/L) | 5 days | No | |
Secondary | Incidence of EEG abnormalities | 2 weeks | No | |
Secondary | Incidence of MRI abnormalities | 2 weeks | No | |
Secondary | Incidence of abnormal neurological examination | 6 months | No | |
Secondary | Incidence of abnormal Denver Developmental Screening Test II | 6 months | No |
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