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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02071160
Other study ID # 01012012
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 23, 2014
Last updated February 23, 2014
Start date January 2012
Est. completion date December 2013

Study information

Verified date February 2014
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Tanta University Children's Hospital Tanta Gharbeya

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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

Outcome

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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