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

University Hospital of Ferrara

Status: Unknown

Conditions: Inflammation; Cell Damage; Neonatal Encephalopathy; Metabolic Acidosis

Study type: Observational

Funder types: Other

Identifiers

NCT03897101

639/2018/Sper/AOUFe

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 15 minutes to 6 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

MILD NE

Description:

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 Plasma levels of melatonin, Atg5, Parkin, Pink1, inflammatory cytokines will be evaluated

ISOLATED METABOLIC ACIDOSIS

Description:

gestational age \> 35 weeks and weight \> 1800 gr * evidence of base excess \> 12 mmol/L or pH \< 7,0 at initial blood gas analyses * Normal Sarnat\&Sarnat neurological evaluation Plasma levels of melatonin, Atg5, Parkin, Pink1, inflammatory cytokines will be evaluated

HEALTY CONTROLS

Description:

gestational age \> 35 weeks and weight \> 1800 gr Normal blood pH or base excess Plasma levels of melatonin, Atg5, Parkin, Pink1, inflammatory cytokiness will be evaluated