Perinatal Asphyxia
Conditions
Keywords
HIE, hypothermia, encephalopathy, anti oxidants, MRI
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.
Interventions
DRUGMelatonin
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Hours
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of EEG abnormalities | 2 weeks |
| Incidence of abnormal Denver Developmental Screening Test II | 6 months |
| Incidence of MRI abnormalities | 2 weeks |
| Incidence of abnormal neurological examination | 6 months |
Countries
Egypt
Outcome results
None listed