Neonatal Hypoxic Ischemic EncephalopathyNCT04364932
Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy
An observational study of Neonatal Hypoxic Ischemic Encephalopathy, run by Assiut University.
Trial summary
Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs notwithstanding. Read more about this study
- Who is it for?
- Ages 24 hours to 28 days
- Conditions the study is for
- Neonatal Hypoxic Ischemic Encephalopathy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2022
- 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 24 hours to 28 days
- All sexes
- Child
Study population: Full term infants with clinic linical signs of neonatal encephalopathy(e.g. irritability, decreased responsiveness, coma, seizures, hypotonia, abnormal primitive reflexes, apnea, feeding disturbance, and abnormal cry), NICU admission, full-term infant with poor condition at birth (5-minute Apgar score <7) and/or need for major resuscitation
Who may be able to join
- Clinical signs of neonatal encephalopathy(e.g. irritability, decreased responsiveness, coma, seizures, hypotonia, abnormal primitive reflexes, apnea, feeding disturbance, and abnormal cry), NICU admission, full-term infant with poor condition at birth (5-minute Apgar score <7) and/or need for major resuscitation.
Who cannot join
- Preterm infant, full term infants with birth asphyxia but with congenital malformations or chromosomal abnormalities, infant of diabetic mother and CNS infections are excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs notwithstanding. In recent years have attempted to quantify the effect, and wider impact of intrapartum compromise, as well as the underlying mechanisms for it. After a poor outcome related to intrapartum care parents and healthcare practitioners often strive to understand whether the event could have been predicted and/or prevented. This can be difficult to answer, at least partly related to the heterogeneous fetal response to perinatal asphyxia. Mothers and the maternity service are increasingly encouraged to personalize care and their choices around the birth process, however the information required to guide these choices is most often missing. This makes it difficult for women and professionals to make an informed choice about their care, including the safest mode of birth for them and their baby.
Aim of the study: Identifying antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.
Read the detailed description
Antenatal, perinatal and postpartum data will be documented from the medical notes and from parental reports including;
- Booking factors (maternal age, smoking, parity, previous lower segment caesarean section (LSCS), multiple births)
- Antenatal factors (preeclampsia, gestational diabetes, prelabor abruption, placenta previa, oligohydramnios, polyhydramnios, threatened preterm labor, gender, concerns of IUGR infant)
- Labor factors (induction of labor, pre-labor rupture of membranes, planned LSCS, gestation at birth, presentation, prelabor breech, breech delivery, duration of ruptured membranes).
- Infant characteristics included GA, gender, birth weight (BW), head circumference, and multiplicity.
- Clinical signs, examination findings and laboratory data also will be included. Most covariates will be extracted from patient's notes, routine data collection or as part of a routine clinical database.
Data will be processed and analyzed using SPSS software and the results will be processed in tables and figures.
- Conditions
- Neonatal Hypoxic Ischemic Encephalopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.
Antenatal, perinatal and postpartum data will be documented from the medical notes and from parental reports including;
- Booking factors (maternal age, smoking, parity, previous lower segment caesarean section (LSCS), multiple births)
- Antenatal factors (preeclampsia, gestational diabetes, prelabor abruption, placenta previa, oligohydramnios, polyhydramnios, threatened preterm labor, gender, concerns of IUGR infant)
- Labor factors (induction of labor, pre-labor rupture of membranes, planned LSCS, gestation at birth, presentation, prelabor breech, breech delivery, duration of ruptured membranes).
- Infant characteristics included GA, gender, birth weight (BW), head circumference, and multiplicity.
- Clinical signs, examination findings and laboratory data also will be included. Most covariates will be extracted from patient's notes, routine data collection or as part of a routine clinical database.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (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 Neonatal Hypoxic Ischemic EncephalopathyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rady Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364932
- Sponsor's protocol ID
- HIE risk factors
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Glass HC. Hypoxic-Ischemic Encephalopathy and Other Neonatal Encephalopathies. Continuum (Minneap Minn). 2018 Feb;24(1, Child Neurology):57-71. doi: 10.1212/CON.0000000000000557.
PubMed 29432237Simiyu IN, Mchaile DN, Katsongeri K, Philemon RN, Msuya SE. Prevalence, severity and early outcomes of hypoxic ischemic encephalopathy among newborns at a tertiary hospital, in northern Tanzania. BMC Pediatr. 2017 May 25;17(1):131. doi: 10.1186/s12887-017-0876-y.
PubMed 28545428Qureshi AM, ur Rehman A, Siddiqi TS. Hypoxic ischemic encephalopathy in neonates. J Ayub Med Coll Abbottabad. 2010 Oct-Dec;22(4):190-3.
PubMed 22455295Odd D, Heep A, Luyt K, Draycott T. Hypoxic-ischemic brain injury: Planned delivery before intrapartum events. J Neonatal Perinatal Med. 2017;10(4):347-353. doi: 10.3233/NPM-16152.
PubMed 29286930
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT04364932
- Acronym / sponsor ID
- HIE risk factors
- Conditions
- Neonatal Hypoxic Ischemic Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Apr 2020 (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.
Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs notwithstanding. In recent years have attempted to quantify the effect, and wider impact of intrapartum compromise, as well as the underlying mechanisms for it. After a poor outcome related to intrapartum care parents and healthcare practitioners often strive to understand whether the event could have been predicted and/or prevented. This can be difficult to answer, at least partly related to the heterogeneous fetal response to perinatal asphyxia. Mothers and the maternity service are increasingly encouraged to personalize care and their choices around the birth process, however the information required to guide these choices is most often missing. This makes it difficult for women and professionals to make an informed choice about their care, including the safest mode of birth for them and their baby.
Aim of the study: Identifying antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.
Detailed description
Antenatal, perinatal and postpartum data will be documented from the medical notes and from parental reports including;
- Booking factors (maternal age, smoking, parity, previous lower segment caesarean section (LSCS), multiple births)
- Antenatal factors (preeclampsia, gestational diabetes, prelabor abruption, placenta previa, oligohydramnios, polyhydramnios, threatened preterm labor, gender, concerns of IUGR infant)
- Labor factors (induction of labor, pre-labor rupture of membranes, planned LSCS, gestation at birth, presentation, prelabor breech, breech delivery, duration of ruptured membranes).
- Infant characteristics included GA, gender, birth weight (BW), head circumference, and multiplicity.
- Clinical signs, examination findings and laboratory data also will be included. Most covariates will be extracted from patient's notes, routine data collection or as part of a routine clinical database.
Data will be processed and analyzed using SPSS software and the results will be processed in tables and figures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 hours to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- Full term infants with clinic linical signs of neonatal encephalopathy(e.g. irritability, decreased responsiveness, coma, seizures, hypotonia, abnormal primitive reflexes, apnea, feeding disturbance, and abnormal cry), NICU admission, full-term infant with poor condition at birth (5-minute Apgar score <7) and/or need for major resuscitation
Key inclusion criteria (1 listed)
- Clinical signs of neonatal encephalopathy(e.g. irritability, decreased responsiveness, coma, seizures, hypotonia, abnormal primitive reflexes, apnea, feeding disturbance, and abnormal cry), NICU admission, full-term infant with poor condition at birth (5-minute Apgar score <7) and/or need for major resuscitation.
Key exclusion criteria (1 listed)
- Preterm infant, full term infants with birth asphyxia but with congenital malformations or chromosomal abnormalities, infant of diabetic mother and CNS infections are 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
Antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.
Time frame: Baseline
Antenatal, perinatal and postpartum data will be documented from the medical notes and from parental reports including; * Booking factors (maternal age, smoking, parity, previous lower segment caesarean section (LSCS), multiple births) * Antenatal factors (preeclampsia, gestational diabetes, prelabor abruption, placenta previa, oligohydramnios, polyhydramnios, threatened preterm labor, gender, concerns of IUGR infant) * Labor factors (induction of labor, pre-labor rupture of membranes, planned LSCS, gestation at birth, presentation, prelabor breech, breech delivery, duration of ruptured membranes). * Infant characteristics included GA, gender, birth weight (BW), head circumference, and multiplicity. * Clinical signs, examination findings and laboratory data also will be included. Most covariates will be extracted from patient's notes, routine data collection or as part of a routine clinical database.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 29432237Glass HC. Hypoxic-Ischemic Encephalopathy and Other Neonatal Encephalopathies. Continuum (Minneap Minn). 2018 Feb;24(1, Child Neurology):57-71. doi: 10.1212/CON.0000000000000557.
- Background: PubMed 28545428Simiyu IN, Mchaile DN, Katsongeri K, Philemon RN, Msuya SE. Prevalence, severity and early outcomes of hypoxic ischemic encephalopathy among newborns at a tertiary hospital, in northern Tanzania. BMC Pediatr. 2017 May 25;17(1):131. doi: 10.1186/s12887-017-0876-y.
- Background: PubMed 22455295Qureshi AM, ur Rehman A, Siddiqi TS. Hypoxic ischemic encephalopathy in neonates. J Ayub Med Coll Abbottabad. 2010 Oct-Dec;22(4):190-3.
- Background: PubMed 29286930Odd D, Heep A, Luyt K, Draycott T. Hypoxic-ischemic brain injury: Planned delivery before intrapartum events. J Neonatal Perinatal Med. 2017;10(4):347-353. doi: 10.3233/NPM-16152.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hypoxic Ischemic Encephalopathy, 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 28 Apr 2020. 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 Radwa Rady, M. B. B. Ch. (01096284005, radwa011200@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy. (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 NCT04364932, 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 28 Apr 2020.