Maternal and Neonatal Risk Factors of HIE

NCT05749458 | Unknown

• 1 other identifier: Risk factors in HIE neonates
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current work aims to: The primary aim in this study was to identify the contribution of maternal, pregnancy, birth and neonatal factors to encephalopathic features in new born infants. The secondary aim of this study is to reduce the burden on the country by decreasing the rate of neonatal encephalopathy, decreasing the different grades of neurodevelopmental impairment and improvement the quality of life.

Conditions

Hypoxic Ischemic Encephalopathy of Newborn

Outcome Measures

Primary Outcomes (1)

• Identify the contribution of maternal, pregnancy, birth and neonatal factors to increase incidence of encephalopathic features in new born infants.

  retrospective study of newborns, who were admitted to the Neonatal intensive care Unit Assiut University Children's Hospital, from January 2019 till the end of December 2023.All outcome measures were summarized using frequencies and percentages or means ± standard deviations, stratified by group (HIE group vs. Non-HIE group). The categorical data were analyzed for statistical significance (p \< 0.05) by Chi-square test or Fisher exact test, or Student t-test. The odds ratio and 95% CI were calculated for those with statistical significance. Stepwise multiple logistic regression analysis used to determine the independent factors that may predispose an infant to HIE.

  Baseline

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

the study population: all neonates less than 28 days old newborns, who were admitted to the Neonatal intensive care Unit Assiut University Children's Hospital, from January 2019 till the end of December 2023.

You may qualify if:

• all neonates less than 28 days old newborns, who were admitted to the Neonatal intensive care Unit Assiut University Children's Hospital, from January 2019 till the end of December 2023.

You may not qualify if:

• Those newborn infants with stillbirth, congenital anomaly, and chromosomal abnormalities or infants with microbiological evidence of early neonatal infection were excluded from the study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Martinez-Biarge M, Diez-Sebastian J, Wusthoff CJ, Mercuri E, Cowan FM. Antepartum and intrapartum factors preceding neonatal hypoxic-ischemic encephalopathy. Pediatrics. 2013 Oct;132(4):e952-9. doi: 10.1542/peds.2013-0511. Epub 2013 Sep 9.

  PMID: 24019409 BACKGROUND

• Peebles PJ, Duello TM, Eickhoff JC, McAdams RM. Antenatal and intrapartum risk factors for neonatal hypoxic ischemic encephalopathy. J Perinatol. 2020 Jan;40(1):63-69. doi: 10.1038/s41372-019-0531-6. Epub 2019 Oct 14.

  PMID: 31611618 BACKGROUND

• Parker SJ, Kuzniewicz M, Niki H, Wu YW. Antenatal and Intrapartum Risk Factors for Hypoxic-Ischemic Encephalopathy in a US Birth Cohort. J Pediatr. 2018 Dec;203:163-169. doi: 10.1016/j.jpeds.2018.08.028. Epub 2018 Sep 27.

  PMID: 30270166 BACKGROUND

• Torbenson VE, Tolcher MC, Nesbitt KM, Colby CE, El-Nashar SA, Gostout BS, Weaver AL, Mc Gree ME, Famuyide AO. Intrapartum factors associated with neonatal hypoxic ischemic encephalopathy: a case-controlled study. BMC Pregnancy Childbirth. 2017 Dec 11;17(1):415. doi: 10.1186/s12884-017-1610-3.

  PMID: 29228911 BACKGROUND

Study Officials

• Abdellatif M. Abd-Elmoaz, Professor

  Assiut University

  STUDY DIRECTOR

• Mohamed G. Abo-Elela, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Marwa M. Kemaly, Master

CONTACT

01090354033; marwa.kemaly@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 1, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02