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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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6 July 2015 |
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Main ID: |
ISRCTN48907674 |
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Date of registration:
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24/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Whole body hypothermia + melatonin vs whole body hypothermia + placebo in asphyctic newborns.
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Scientific title:
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Whole body hypothermia + melatonin vs whole body hypothermia + placebo in asphyctic newborns. A multicentric, randomized, controlled and double blind clinical trial |
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Date of first enrolment:
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01/11/2014 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN48907674 |
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Study type:
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Interventional |
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Study design:
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Randomized, controlled, double blind, placebo vs treatment. Multicentric design (Treatment)
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Antonio
Jerez Calero |
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Address:
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c/Albeniz, 11 bis
Cajar
18199
Granada
Spain |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Newborns, Gestational age <36 weeks and at least ONE of the following:
1.1. Apgar test poor at 5 minutes from birth
1.2. Need for resuscitation longer than 10 minutes using positive pressure ventilation (bag and mask or endotraqueal tube)
1.3. Ph <7 or BD<16 mmol/L in the worse gasometric result at first 60 minutes from birth (cord, arterial, venous or capillary blood sample)
2. Moderate and severe hypoxic-ischemic encephalopathy:
2.1. Sarnat score >6 points
Exclusion criteria: 1. Birth weight <1800 g
2. Gestational age < 36 weeks
3. Newborn older than 6 hours
4. Need for surgery during first 3 days of life
5. Severe congenital malformations
6. Severe multiorganic dysfunction and refractory to treatment
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nervous System Disease
Nervous System Diseases
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Intervention(s)
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Beginning within first 6 hours of life, newborns under treatment will receive a intravenous perfusion of melatonin. Dosis= 5 mg per Kilogram of weight per day. Duration of the substance treatment= 3 days (equal to hypothermia treatment period) (total doses= 3).
Other newborns will receive placebo. The neonatologist, nursing team or statistics don´t know which treatment have been administered because of a doubled blind design.
Follow up include intensive monitoring at the Neonatal Intensive Care Unit during the critical period of the illness. We´ll take blood and urine samples to determine inflammatory biochemical markers. We will also assess neurological sequelae (standardized tests of psychomotor development, testing, neuroimaging and sensory disturbances and / or refractory seizures)
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Primary Outcome(s)
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Better scores on neurodevelopment test in cooled newborns treated with melatonin vs placebo at 6 months and 18 months of age
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Secondary Outcome(s)
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1. Lower plasmatic concentrations of proinflamatory biomarkers derivated of oxidative stress and neuronal damage
2. Type and of brain damaged areas obtained by Magnetic Resonance Imaging
3. Poor prognosis electroencephalographic patterns at Function Cerebral Monitor
Measured at 3-6 hours, 24 hours, 72 hours and then 7-10 days after birth
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Secondary ID(s)
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2012-000184-24
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Source(s) of Monetary Support
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Health General Institute: Ministry of Health, Social Services and Equality (Ministerio de Sanidad y consumo) (Spain)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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