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Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy

Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04364932
Enrollment
100
Registered
2020-04-28
Start date
2021-09-30
Completion date
2022-12-31
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Brief 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. 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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 28 Days

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.BaselineAntenatal, 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.

Contacts

Primary ContactRadwa Rady, M. B. B. Ch.
radwa011200@med.aun.edu.eg01096284005
Backup ContactAbdel-Latef Abdel-Moez, Professor
a.m.abdelmoez@aun.edu.eg01005208016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026