P80
Conditions
Interventions
Group 1: Arm 1 (prospective cohort):
Neonates = 35+0 weeks of gestation with risk factors for thermoregulatory disturbance or hypoglycaemia under a newly introduced structured hypothermia prevention b
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
0 Days to No maximum
Inclusion criteria
Inclusion criteria: Neonates born at our institution with a gestational age of = 35+0 weeks of gestation who have at least one of the defined risk factors for thermoregulatory disturbance or hypoglycaemia are eligible for study participation. Prerequisites for enrolment are written informed consent from the parents and sufficient German language skills to safely understand the study contents, including the information materials and consent form. Defined risk factors are: Small-for-gestational-age status (birth weight 90th percentile) Late prematurity (35+0–36+6 weeks of gestation) Infants of diabetic mothers (pre-existing maternal diabetes or gestational diabetes) Perinatal stress (e.g. asphyxia, respiratory adaptation disorder, arterial umbilical cord pH < 7.1, delivery by vacuum extraction or secondary caesarean section due to pathological cardiotocography) Maternal risk factors (pre-eclampsia/HELLP syndrome, arterial hypertension, medical treatment with beta-blockers, antidepressants, or metformin) The above inclusion and exclusion criteria apply to all three study cohorts. The historical control cohort comprises data collected between May 2020 and September 2022; the retrospective validation cohort comprises data from the period April 2025 to March 2026.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Neonates will be excluded from the study if any of the following criteria apply: Preterm neonates with a gestational age < 35+0 weeks of gestation Severe congenital malformations with a direct impact on thermoregulation or glucose metabolism (e.g. malformations of the central nervous system, endocrine or metabolic disorders such as congenital hypothyroidism, adrenal hyperplasia, or known congenital metabolic disorders) Severe perinatal illness or cardiorespiratory instability immediately after birth, present prior to study enrolment and rendering study participation medically unjustifiable Transfer to another institution (external hospital transfer) before data collection can be initiated Missing or withdrawn written informed consent from the parents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Incidence of postnatal hypothermia (rectal temperature < 36.5 °C) in at-risk neonates, assessed by standardised rectal temperature measurements according to the institutional standard operating procedure (SOP) within the first 48 hours of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of neonatal hypoglycaemia (blood glucose < 45 mg/dl), assessed by routine blood glucose measurements according to the institutional SOP within the first 48 hours of life. 2. Severity (35.0–36.4 °C or < 35.0 °C) and cumulative duration of hypothermia episodes, and time to stable normothermia (= 36.5 °C), assessed by rectal temperature measurements within the first 48 hours of life. 3. Occurrence of hyperthermia (= 37.5 °C) as a safety outcome, assessed by rectal temperature measurements within the first 48 hours of life. 4. Adherence to SOP elements (drying, hat, skin-to-skin contact, room temperature, warming devices) and completeness of temperature documentation and participation in staff/parental training, assessed using structured documentation instruments during the inpatient stay. 5. Hospital admission for thermoregulatory or metabolic reasons, length of stay, and readmission within 7 days, assessed from medical records. Exploratory: Risk modifiers (gestational age, birth weight, mode of delivery, maternal diabetes, maternal medication, perinatal stress, season), assessed from birth records and maternal health booklet (Mutterpass) at the time of birth. | — |
Countries
Germany
Contacts
Public ContactCalvin Kurz
Universitätsklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed