Maternal and Neonatal Risk Factors of HIE

NCT ID: NCT05749458

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxic Ischemic Encephalopathy of Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marwa Mamdouh Kemaly

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abdellatif M. Abd-Elmoaz, Professor

Role: STUDY_DIRECTOR

Assiut University

Mohamed G. Abo-Elela, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marwa M. Kemaly, Master

Role: CONTACT

01090354033

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24019409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31611618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30270166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29228911 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Risk factors in HIE neonates

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Developmental Outcomes
NCT02264808 COMPLETED