P21.0
Conditions
Interventions
Group 1: The aim of the project is to identify factors influencing the long-term neuroprotective efficacy of hypothermia treatment after perinatal asphyxia in newborns. A particular focus is placed on
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
No minimum to 8 Years
Inclusion criteria
Inclusion criteria: Participants will be newborns with a gestational age of =36 weeks who, from April 1, 2025 onward, fulfilled the postnatal criteria for perinatal asphyxia and were treated with therapeutic hypothermia. The criteria for perinatal asphyxia are: i) postnatal pH =7.0 and/or base deficit =15 mmol/L measured in umbilical arterial blood or in a blood sample obtained within the first hour of life, ii) Apgar score 1 or pathological amplitude-integrated EEG).
Exclusion criteria
Exclusion criteria: Preterm infants <30 weeks of gestation, as well as newborns =36 weeks of gestation who did not fulfill the postnatal asphyxia criteria or who had a congenital malformation or intracerebral hemorrhage, will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of clinical factors influencing treatment success and outcome (death or severe disability at 2, 4, 6, or 7 years of age). The data are collected from the patients’ medical records. The study participants are examined at standardized time points in the neonatal follow-up clinic up to 24 months of age. Assessments at 4 and 6/7 years of age are conducted at the Social Pediatric Center as part of routine clinical follow-up in pediatrics. As this is a data analysis, no risks, disadvantages, or harm are to be expected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Birth-related data are collected (e.g., socioeconomic status, gestational age, week of gestation, prenatal risk factors, birth weight, length, head circumference, Apgar scores, umbilical cord pH), as well as perinatal risk factors (e.g., resuscitation at birth, presence of amniotic infection syndrome, lactate levels after birth, catecholamine therapy, volume therapy during initial stabilization) and postnatal risk factors (e.g., mechanical ventilation, sepsis, persistent ductus arteriosus Botalli, catecholamine therapy, grade of hypoxic-ischemic encephalopathy, seizures). In addition, patient outcomes (death or long-term Bayley II outcome up to 6/7 years of age) are obtained from the medical records. | — |
Countries
Germany
Contacts
Public ContactHemmen Sabir
Universitätsklinikum Bonn
Outcome results
None listed