NCT03897101

Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)

Autophagy, Mitophagy, Inflammation and Plasmatic Concentration of Melatonin in Newborn With Metabolic Acidosis at Birth

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 15 Minutes – 6 Hours
• Healthy volunteers: Accepted

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.

Conditions

• Neonatal Encephalopathy
• Cell Damage
• Metabolic Acidosis
• Inflammation

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2019-04-01
• Last updated: 2020-03-25

Locations

2 sites across 1 country: Italy