Viewing Study NCT05749458



Ignite Creation Date: 2024-05-06 @ 6:40 PM
Last Modification Date: 2024-10-26 @ 2:52 PM
Study NCT ID: NCT05749458
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-03-01
First Post: 2023-01-31

Brief Title: Maternal and Neonatal Risk Factors of HIE
Sponsor: Assiut University
Organization: Assiut University

Study Overview

Official Title: Retrospective Study on Maternal and Neonatal Risk Factors That Contribute to Hypoxic Ischemic Encephalopathy in Neonates
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 infants 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 deathstillbirth 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None