Inflammation Clinical Trial
— AGAINOfficial title:
Autophagy, Mitophagy, Inflammation and Plasmatic Concentration of Melatonin in Newborn With Metabolic Acidosis at Birth
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 .
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital "Sant'Anna" of Ferrara | Ferrara | |
Italy | Infermi Hospital Rimini | Rimini |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara | AUSL Romagna Rimini |
Italy,
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Prempunpong C, Chalak LF, Garfinkle J, Shah B, Kalra V, Rollins N, Boyle R, Nguyen KA, Mir I, Pappas A, Montaldo P, Thayyil S, Sánchez 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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | change from baseline Plasma Concentration of Melatonin at 7 days of life | UPLC-Massa Acquity-Xevo TQD (Waters) will be used to measure plasma melatonin concentration. | birth, 72 hours, 7 days of life | |
Other | change from baseline of inflammatory cytokines at 7 days of life | correlation between metabolic acidosis at birth and inflammatory cytokines. ELISA test will be used to measure plasma levels inflammatory cytokines. | birth, 72 hours, 7 days of life | |
Primary | change from baseline ATG5 Plasma concentration at 7 days of life | correlation between metabolic acidosis at birth and Autophagy. ELISA test will be used to measure plasma levels of ATG5 | birth, 72 hours, 7 days of life | |
Secondary | change from baseline Parkin and Pink1 Plasma concentration at 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 | birth, 72 hours, 7 days of life |
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