Cell Damage, Inflammation, Metabolic Acidosis, Neonatal Encephalopathy
Conditions
Keywords
mild neonatal encephalopathy, birth asphyxia, metabolic acidosis, Autophagy, Mitophagy, inflammation
Brief summary
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births. Over the last six years, several randomized control trials have demonstrated that therapeutic hypothermia reduces the rate of death or disability at 18 months of age among infants who survived. However, the neurodevelopmental outcome in milder NE not treated with hypothermia remains unclear. A multicenter prospective observational study will be conducted to determine biological changes of mild neonatal encephalopathy who are not recruited for therapeutic hypothermia .
Detailed description
It is a prospective observational multicenter study on 50 newborns with mild neonatal encephalopathy and metabolic acidosis at birth not qualified for therapeutic hypothermia compared to healthy controls. Infants with metabolic acidosis at birth and evidence of mild encephalopathy graded according to Sarnat&Sarnat neurological evaluation will be recruited to evaluate plasma concentration of melatonin and levels of Autophagy, mitophagy and inflammation. Plasmatic changes will be compared to: * healthy control * infants with isolated metabolic acidosis at birth and normal neurological evaluation.
Interventions
None listed
Sponsors
AUSL Romagna Rimini
University Hospital of Ferrara
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Minutes to 6 Hours
Healthy volunteers
Yes
Inclusion criteria
* gestational age \> 35 weeks and weight \> 1800 gr * Apgar score \< 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutes or evidence of base excess \> 12 mmol/L or pH \< 7,0 at initial blood gas analyses * evidence of mild encephalopathy graded according to Sarnat&Sarnat neurological evaluation * normal amplitude integrated electroencephalography
Exclusion criteria
* suspected inborn errors of metabolism * major chromosomal congenital defects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline ATG5 Plasma concentration at 7 days of life | birth, 72 hours, 7 days of life | correlation between metabolic acidosis at birth and Autophagy. ELISA test will be used to measure plasma levels of ATG5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline Parkin and Pink1 Plasma concentration at 7 days of life | birth, 72 hours, 7 days of life | correlation between metabolic acidosis at birth and Mitophagy. ELISA test will be used to measure plasma levels of Parkin and Park1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| change from baseline Plasma Concentration of Melatonin at 7 days of life | birth, 72 hours, 7 days of life | UPLC-Massa Acquity-Xevo TQD (Waters) will be used to measure plasma melatonin concentration. |
| change from baseline of inflammatory cytokines at 7 days of life | birth, 72 hours, 7 days of life | correlation between metabolic acidosis at birth and inflammatory cytokines. ELISA test will be used to measure plasma levels inflammatory cytokines. |
Countries
Italy
Contacts
Primary ContactAnna Tarocco, MD
Backup ContactPaolo Pinton, Prof
Outcome results
None listed