Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)
NCT ID: NCT03897101
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2019-03-01
2020-12-31
Brief Summary
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A multicenter prospective observational study will be conducted to determine biological changes of mild neonatal encephalopathy who are not recruited for therapeutic hypothermia .
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* major chromosomal congenital defects
15 Minutes
6 Hours
ALL
Yes
Sponsors
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AUSL Romagna Rimini
OTHER
University Hospital of Ferrara
OTHER
Responsible Party
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Anna Tarocco
Medical Doctor, Principal Investigator
Principal Investigators
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Anna Tarocco, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital s. Anna Ferrara
Locations
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University Hospital "Sant'Anna" of Ferrara
Ferrara, , Italy
Infermi Hospital Rimini
Rimini, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Alirezaei M, Kemball CC, Whitton JL. Autophagy, inflammation and neurodegenerative disease. Eur J Neurosci. 2011 Jan;33(2):197-204. doi: 10.1111/j.1460-9568.2010.07500.x. Epub 2010 Dec 7.
Wang Q, Lv H, Lu L, Ren P, Li L. Neonatal hypoxic-ischemic encephalopathy: emerging therapeutic strategies based on pathophysiologic phases of the injury. J Matern Fetal Neonatal Med. 2019 Nov;32(21):3685-3692. doi: 10.1080/14767058.2018.1468881. Epub 2018 May 2.
Hassell KJ, Ezzati M, Alonso-Alconada D, Hausenloy DJ, Robertson NJ. New horizons for newborn brain protection: enhancing endogenous neuroprotection. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F541-52. doi: 10.1136/archdischild-2014-306284. Epub 2015 Jun 10.
McAdams RM, Juul SE. Neonatal Encephalopathy: Update on Therapeutic Hypothermia and Other Novel Therapeutics. Clin Perinatol. 2016 Sep;43(3):485-500. doi: 10.1016/j.clp.2016.04.007. Epub 2016 Jun 22.
Parikh P, Juul SE. Neuroprotective Strategies in Neonatal Brain Injury. J Pediatr. 2018 Jan;192:22-32. doi: 10.1016/j.jpeds.2017.08.031. Epub 2017 Oct 12. No abstract available.
Martinello K, Hart AR, Yap S, Mitra S, Robertson NJ. Management and investigation of neonatal encephalopathy: 2017 update. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F346-F358. doi: 10.1136/archdischild-2015-309639. Epub 2017 Apr 6.
Massaro AN, Wu YW, Bammler TK, Comstock B, Mathur A, McKinstry RC, Chang T, Mayock DE, Mulkey SB, Van Meurs K, Juul S. Plasma Biomarkers of Brain Injury in Neonatal Hypoxic-Ischemic Encephalopathy. J Pediatr. 2018 Mar;194:67-75.e1. doi: 10.1016/j.jpeds.2017.10.060.
Prempunpong C, Chalak LF, Garfinkle J, Shah B, Kalra V, Rollins N, Boyle R, Nguyen KA, Mir I, Pappas A, Montaldo P, Thayyil S, Sanchez PJ, Shankaran S, Laptook AR, Sant'Anna G. Prospective research on infants with mild encephalopathy: the PRIME study. J Perinatol. 2018 Jan;38(1):80-85. doi: 10.1038/jp.2017.164. Epub 2017 Nov 2.
Tarocco A, Morciano G, Perrone M, Cafolla C, Ferre C, Vacca T, Pistocchi G, Meneghin F, Cocchi I, Lista G, Cetin I, Greco P, Garani G, Stella M, Natile M, Ancora G, Savarese I, Campi F, Bersani I, Dotta A, Tiberi E, Vento G, Chiodin E, Staffler A, Maranella E, Di Fabio S, Wieckowski MR, Giorgi C, Pinton P. Increase of Parkin and ATG5 plasmatic levels following perinatal hypoxic-ischemic encephalopathy. Sci Rep. 2022 May 12;12(1):7795. doi: 10.1038/s41598-022-11870-w.
Other Identifiers
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639/2018/Sper/AOUFe
Identifier Type: -
Identifier Source: org_study_id
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