Indicators of Neuronal Insult in Newborns of COVID-19 Positive Mothers.

NCT05175638 | Unknown

• 1 other identifier: NER
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The coronavirus disease (COVID- 19) is now a global pandemic that was first reported in China (Wuhan) in December of 2019. Multiple placental abnormalities including fetal and maternal vascular malperfusion have been described in pregnant women infected with (COVID- 19). To date, there are far fewer reports about the specific effects of (COVID- 19) in the newborns delivered for (COVID- 19) positive mothers.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

• the expression of specific CNS enzyme (enolase), proinflammatory cytokines MIF and apoptotic marker caspase-3 in the umbilical blood of infants delivered for Covid positive mothers.

  RNA extraction Reverse Transcription polymerase chain reaction (RT-PCR) analysis:

  one month

Study Arms (2)

Control

A total of 20 term newborn infants with a median gestational age of 40 weeks (range: 37-42 weeks) will be selected from the Gynecology and Obstetrics Hospital (Assiut University). All control infants should have an Apgar score of \> 9 at 1, 5, and 10 minutes.

Genetic: Gene Expression

Study group

Thirty newborn infants born for Covid-19 positive mothers will be prospectively included in this study. The diagnosis of hypoxia will made based on Apgar score, clinical signs present during the first hours of life and acid-base status. The following inclusion criteria will be used (all necessary): Covid-19 positive mothers, term newborn (\>37 completed gestational weeks), free from severe malformations. All infants will be examined generally, systemically and neurologically at birth for clinical assessment of HIE if present and for detection of outcome of these neonates.

Genetic: Gene Expression

Interventions

Gene Expression GENETIC

the expression of specific CNS enzyme (enolase), proinflammatory cytokines MIF and apoptotic marker caspase-3 in the umbilical blood of infants delivered for Covid positive mothers.

Control; Study group

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Fifty newborn babies will be recruited from Assiut university hospital and included in this study. Thirty newborn babies delivered for COVID 19 positive mothers, and 20 newborns delivered for normal mothers will be used as control group. Informed consent will be obtained from mothers.

You may not qualify if:

• free from severe malformations

Sponsors & Collaborators

• Assiut University: lead

Related Publications (15)

• Aksakal A, Kerget B, Kerget F, Askin S. Evaluation of the relationship between macrophage migration inhibitory factor level and clinical course in patients with COVID-19 pneumonia. J Med Virol. 2021 Dec;93(12):6519-6524. doi: 10.1002/jmv.27189. Epub 2021 Jul 22.

  PMID: 34241898 BACKGROUND

• Bleilevens C, Soppert J, Hoffmann A, Breuer T, Bernhagen J, Martin L, Stiehler L, Marx G, Dreher M, Stoppe C, Simon TP. Macrophage Migration Inhibitory Factor (MIF) Plasma Concentration in Critically Ill COVID-19 Patients: A Prospective Observational Study. Diagnostics (Basel). 2021 Feb 17;11(2):332. doi: 10.3390/diagnostics11020332.

  PMID: 33671433 BACKGROUND

• Chaparro-Huerta V, Flores-Soto ME, Merin Sigala ME, Barrera de Leon JC, Lemus-Varela ML, Torres-Mendoza BM, Beas-Zarate C. Proinflammatory Cytokines, Enolase and S-100 as Early Biochemical Indicators of Hypoxic-Ischemic Encephalopathy Following Perinatal Asphyxia in Newborns. Pediatr Neonatol. 2017 Feb;58(1):70-76. doi: 10.1016/j.pedneo.2016.05.001. Epub 2016 May 31.

  PMID: 27522459 BACKGROUND

• Deng C, Li J, Li L, Sun F, Xie J. Effects of hypoxia ischemia on caspase-3 expression and neuronal apoptosis in the brain of neonatal mice. Exp Ther Med. 2019 Jun;17(6):4517-4521. doi: 10.3892/etm.2019.7487. Epub 2019 Apr 15.

  PMID: 31086583 BACKGROUND

• Florez-Sampedro L, Brandsma CA, de Vries M, Timens W, Bults R, Vermeulen CJ, van den Berge M, Obeidat M, Joubert P, Nickle DC, Poelarends GJ, Faiz A, Melgert BN. Genetic regulation of gene expression of MIF family members in lung tissue. Sci Rep. 2020 Oct 12;10(1):16980. doi: 10.1038/s41598-020-74121-w.

  PMID: 33046825 BACKGROUND

• Ganti L, Serrano E, Toklu HZ. Can Neuron Specific Enolase Be a Diagnostic Biomarker for Neuronal Injury in COVID-19? Cureus. 2020 Oct 19;12(10):e11033. doi: 10.7759/cureus.11033.

  PMID: 33214960 BACKGROUND

• Gladkevich A, Kauffman HF, Korf J. Lymphocytes as a neural probe: potential for studying psychiatric disorders. Prog Neuropsychopharmacol Biol Psychiatry. 2004 May;28(3):559-76. doi: 10.1016/j.pnpbp.2004.01.009.

  PMID: 15093964 BACKGROUND

• Golden TN, Simmons RA. Maternal and neonatal response to COVID-19. Am J Physiol Endocrinol Metab. 2020 Aug 1;319(2):E315-E319. doi: 10.1152/ajpendo.00287.2020. Epub 2020 Jun 23.

  PMID: 32574110 BACKGROUND

• Haque A, Polcyn R, Matzelle D, Banik NL. New Insights into the Role of Neuron-Specific Enolase in Neuro-Inflammation, Neurodegeneration, and Neuroprotection. Brain Sci. 2018 Feb 18;8(2):33. doi: 10.3390/brainsci8020033.

  PMID: 29463007 BACKGROUND

• Hekimoglu B, Akturk Acar F. Effects of COVID-19 pandemic period on neonatal mortality and morbidity. Pediatr Neonatol. 2022 Jan;63(1):78-83. doi: 10.1016/j.pedneo.2021.08.019. Epub 2021 Oct 27.

  PMID: 34776364 BACKGROUND

• Isgro MA, Bottoni P, Scatena R. Neuron-Specific Enolase as a Biomarker: Biochemical and Clinical Aspects. Adv Exp Med Biol. 2015;867:125-43. doi: 10.1007/978-94-017-7215-0_9.

  PMID: 26530364 BACKGROUND

• Jain P, Thakur A, Kler N, Garg P. Manifestations in Neonates Born to COVID-19 Positive Mothers. Indian J Pediatr. 2020 Aug;87(8):644. doi: 10.1007/s12098-020-03369-x. Epub 2020 Jun 5. No abstract available.

  PMID: 32504454 BACKGROUND

• Wang S, Guo L, Chen L, Liu W, Cao Y, Zhang J, Feng L. A Case Report of Neonatal 2019 Coronavirus Disease in China. Clin Infect Dis. 2020 Jul 28;71(15):853-857. doi: 10.1093/cid/ciaa225.

  PMID: 32161941 BACKGROUND

• Wu YT, Liu J, Xu JJ, Chen YF, Yang W, Chen Y, Li C, Wang Y, Liu H, Zhang C, Jiang L, Qian ZX, Kawai A, Mol BW, Dennis CL, Xiong GP, Cheng BH, Yang J, Huang HF. Neonatal outcome in 29 pregnant women with COVID-19: A retrospective study in Wuhan, China. PLoS Med. 2020 Jul 28;17(7):e1003195. doi: 10.1371/journal.pmed.1003195. eCollection 2020 Jul.

  PMID: 32722722 BACKGROUND

• Zeng L, Xia S, Yuan W, Yan K, Xiao F, Shao J, Zhou W. Neonatal Early-Onset Infection With SARS-CoV-2 in 33 Neonates Born to Mothers With COVID-19 in Wuhan, China. JAMA Pediatr. 2020 Jul 1;174(7):722-725. doi: 10.1001/jamapediatrics.2020.0878.

  PMID: 32215598 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

Rasha Mohammed, MD.

CONTACT

01010024021; rasha.mohamed94@yahoo.com

Ebtihal Osman, MD.

CONTACT

01004270932; ebthal2@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 1, 2022
• First Posted: January 4, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01