Skip to main content
Clinical Trials/NCT05749458
NCT05749458
Not yet recruiting
Not Applicable

Retrospective Study on Maternal and Neonatal Risk Factors That Contribute to Hypoxic Ischemic Encephalopathy in Neonates

Assiut University0 sites100 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxic Ischemic Encephalopathy of Newborn
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
Identify the contribution of maternal, pregnancy, birth and neonatal factors to increase incidence of encephalopathic features in new born infants.
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Detailed Description

Brain injury in the full-term and near-term gestation neonate is a significant contributor to mortality and long-term morbidity, secondary to the vulnerability of the developing brain to injury. Causes of early brain injury include stroke, birth trauma, metabolic or genetic disorders, neonatal-onset epilepsies, and a variety of perinatal events that lead to decreased blood flow or oxygen delivery to the brain. This last cause is the most common cause of perinatal brain injury. It usually presents with neonatal encephalopathy, or an abnormal neurological examination and is estimated to occur in 3 to 5 in 1000 live births. The Sarnat and Sarnat classification is still the universally accepted scoring system to provide information about the prognosis for the asphyxiated neonate. This staging is based on the infant's clinical presentation, examination findings and the presence of seizures, with emphasis on the duration of symptoms. Martinez-Biarge et al. reported some intrapartum factors associated with the development of HIE- Intrapartum maternal fever, prolonged rupture of membranes, Placental abruption, Ruptured uterus, thick meconium, and gestational age ≥ 41 weeks. In their case-control study of infants born beyond 36 weeks gestation, Hayes et al. identified several risk factors for the development of HIE including thick meconium, fetal growth restriction, large head circumference, oligohydramnios, male fetal sex, fetal bradycardia, maternal pyrexia, and increased uterine contractility. Previously identified antenatal risk factors for HIE include nulliparity, gestation \> 41 weeks, intrauterine growth restriction, maternal age \> 35 years, and urinary tract infection during pregnancy. Previously identified intrapartum risk factors for HIE include sentinel events, emergency cesarean delivery, prolonged rupture of membranes, presence of meconium, shoulder dystocia, maternal fever, and clinical chorioamnionitis. Also, associated factors of HIE include maternal factors such as maternal age (years), parity (primigravida- multigravida), maternal hypertension, pre-eclampsia, gestational DM, Previous fetal death/stillbirth and prior cesarean section. maternal pre-eclampsia with HELLP syndrome and umbilical cord prolapse have been shown to be a risk for asphyxia (14). Route of delivery (Vaginal - Cesarean section) and neonatal factors as gestational age (weeks), gender, Birth weight (grams) and Apgar score if available. An Apgar scores at 5 min provides useful prognostic data before other evaluations are available. Low Apgar scores at 1, 5 and 10 min have been found to be markers with possible increased risk of death or chronic motor disability.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
December 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Mamdouh Kemaly

Resident

Assiut University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline

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.

Similar Trials