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

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ClinicalTrials.gov Identifier: NCT03897101
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
AUSL Romagna Rimini
Information provided by (Responsible Party):
Anna Tarocco, University Hospital of Ferrara

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 .


Condition or disease
Neonatal Encephalopathy Cell Damage Metabolic Acidosis Inflammation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Autophagy, Mitophagy, Inflammation and Plasmatic Concentration of Melatonin in Newborn With Metabolic Acidosis at Birth
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Group/Cohort
MILD NE

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

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

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




Primary Outcome Measures :
  1. change from baseline ATG5 Plasma concentration at 7 days of life [ Time Frame: 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 Outcome Measures :
  1. change from baseline Parkin and Pink1 Plasma concentration at 7 days of life [ Time Frame: 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 Outcome Measures:
  1. change from baseline Plasma Concentration of Melatonin at 7 days of life [ Time Frame: birth, 72 hours, 7 days of life ]
    UPLC-Massa Acquity-Xevo TQD (Waters) will be used to measure plasma melatonin concentration.

  2. change from baseline of inflammatory cytokines at 7 days of life [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
will be recruited 50 newborns with mild neonatal encephalopathy and metabolic acidosis at birth not qualified for therapeutic hypothermia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897101


Contacts
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Contact: Anna Tarocco, MD +39 0532236014 anna.tarocco@unife.it
Contact: Paolo Pinton, Prof 0532455802 paolo.pinton@unife.it

Locations
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Italy
University Hospital "Sant'Anna" of Ferrara Recruiting
Ferrara, Italy, 44124
Contact: Anna Tarocco, MD    +390532236014    anna.tarocco@unife.it   
Contact: Paolo Pinton, Prof    +390532455802    paolo.pinton@unife.it   
Infermi Hospital Rimini Recruiting
Rimini, Italy, 47923
Contact: Gina Ancora, MD PhD    +390541705445    gina.ancora@auslromagna.it   
Contact: Miria Natile, MD    +390541705445    mirianatile@gmail.com   
Sponsors and Collaborators
University Hospital of Ferrara
AUSL Romagna Rimini
Investigators
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Principal Investigator: Anna Tarocco, MD University Hospital s. Anna Ferrara

Additional Information:

Publications:

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Responsible Party: Anna Tarocco, Medical Doctor, Principal Investigator, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03897101     History of Changes
Other Study ID Numbers: 639/2018/Sper/AOUFe
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Tarocco, University Hospital of Ferrara:
mild neonatal encephalopathy
birth asphyxia
metabolic acidosis
Autophagy
Mitophagy
inflammation
Additional relevant MeSH terms:
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Brain Diseases
Acidosis
Inflammation
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Acid-Base Imbalance
Metabolic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants