Hypoxic Ischemic Encephalopathy of NewbornNCT05749458
Maternal and Neonatal Risk Factors of HIE
An observational study of Hypoxic Ischemic Encephalopathy of Newborn, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy of Newborn
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Those newborn infants with stillbirth, congenital anomaly, and chromosomal abnormalities or infants with microbiological evidence of early neonatal infection were excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrospective Study on Maternal and Neonatal Risk Factors That Contribute to Hypoxic Ischemic Encephalopathy in Neonates
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Nov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypoxic Ischemic Encephalopathy of NewbornStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mamdouh Kemaly, Assiut University
- Investigators
- Abdellatif M. Abd-Elmoaz, Professor, Study director, Assiut UniversityMohamed G. Abo-Elela, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749458
- Sponsor's protocol ID
- Risk factors in HIE neonates
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24019409Peebles 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.
PubMed 31611618Parker 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.
PubMed 30270166Torbenson 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.
PubMed 29228911
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Maternal and Neonatal Risk Factors That Contribute to Hypoxic Ischemic Encephalopathy in Neonates
- ClinicalTrials.gov ID
- NCT05749458
- Acronym / sponsor ID
- Risk factors in HIE neonates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Those newborn infants with stillbirth, congenital anomaly, and chromosomal abnormalities or infants with microbiological evidence of early neonatal infection were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 24019409Martinez-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.
- Background: PubMed 31611618Peebles 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.
- Background: PubMed 30270166Parker 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.
- Background: PubMed 29228911Torbenson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdellatif M. Abd-Elmoaz, Professor study director
Assiut University
Mohamed G. Abo-Elela, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic Ischemic Encephalopathy of Newborn, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa M. Kemaly, Master (01090354033, marwa.kemaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the contribution of maternal, pregnancy, birth and neonatal factors to increase incidence of encephalopathic features in new born infants. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749458, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.