Hipothermia plus melatonine neuroprotection terapy in asphixiated newborns.
Conditions
Interventions
Product Name: MELATONINA IV
Product Code: MELATONINA IV
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Melatonin
CAS Number: 73-31-4
Current Sponsor code: PNF-MEL-6-01
Other descript
Sponsors
ANTONIO JEREZ CALERO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with A and B criteria. (and whose parents legal guardian has accepted and signed the informed consent document) A. Newborns, Gestational age >36 weeks, within 6 hours of birth and at least ONE of the followings: - Apgar test 6 points Are the trial subjects under 18? yes Number of subjects for this age range: 36 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Birth weight <1800 g - Gestacional age < 36 weeks - Newborn with over 6 hours of life - Need for surgery during first 3 days of life - Severe congenital malformations - Severe multiorganic disfunction and refractaria treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In asphyctic and cooled newborn we expect that Melatonin administration will decrease neurolesive free radicals production and wil prevent neurological damage derivated of their antiiflamatories and oxidative effects.;Secondary Objective: Other consequences: - measure of proinflamatory biomarkers derivated of oxidative stress and neuronal damage - Neurodevelopment assessment at 6 and 18 months specific tests - Magnetic Resonance Cerebral Images abnormalities - Electroencephalografic patterns in Cerebral Function Monitor - Visual and brain stem evoked potentials Monitoring security settings: - Hematologic: anemia, thrombocytopenia, leukopenia or neutropenia, coagulopathy - Digestive: days of parenteral nutrition, cholestasis, significant elevation of transaminases,NEC or days to full enteral nutrition. - Infectious : sepsis. Alteration of analytical infectious markers - Neurological : intraventricular hemorrhage , white matter injury, clinical/EEG seizures - Renal: Oligoanuria, glycosuria , proteinuria; serum urea and creatinine , hypertension - Respiratory: days of mechanical ventilation/oxigen, need for NO, pneumothorax - Skin: subcutaneous fat necrosis, dermatitis or other notable changes .;Primary end point(s): Better scores on Neurodevelopment test in cooled newborns treated with melatonin vs placebo;Timepoint(s) of evaluation of this end point: 6 and 18 months of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -lower plasmatic concentrations of proinflamatory biomarkers derivated of oxidative stress and neuronal damage (end point n. 2) - Type and of brain damaged areas obtained by Magnetic Resonance Imaging (end point n. 3) - poor prognosis electroencephalografic patterns at Function Cerebral Monitor (end point n. 4);Timepoint(s) of evaluation of this end point: - End point n. 2: 3-6 hours, 24 h, 72 h and 7-10 days of life - End point n. 3: newborn period and 12 months of life - End point n. 4: during first 72 hours of life (at least) | — |
Countries
Spain
Contacts
Public ContactJACQUELINE GUALDA RIVAS
FIBAO
Outcome results
None listed