Acute neonatal emergencies short before/after birth.
Conditions
Interventions
Group 1: Arm 1 (Intervention): 24/7 acute teleneonatology support via a hub-and-spoke network (real-time video consultation with a perinatal center) in predefined neonatal emergencies (“trigger cases”
Sponsors
KinderUniKlinik Ostbayern (KUNO), Klinik St. Hedwig, Barmherzige Brüder Regensburg
Eligibility
Sex/Gender
All
Age
0 Days to No maximum
Inclusion criteria
Inclusion criteria: Newborns delivered in one of the participating maternity units during the study period. Presence of at least one predefined neonatal trigger criterion (acute clinical condition requiring neonatal decision support) immediately after birth. Occurrence of at least one of the predefined trigger criteria from one of the 6 trigger groups A-F: A: Perinatal risk: Emergency delivery, silent CTG, placental abruption, uncovered uterine rupture, suspected perinatal asphyxia B: Resuscitation/severe primary adaptation disorder: Ongoing resuscitation (> 1 cycle of chest compressions), limp infant (> 5 initial ventilations with no response from the infant), umbilical cord pH 5 minutes D: Other acute emergencies: Persistent cyanosis (> 5 minutes) of any cause Severe recurrent hypoglycemia (<30 mg/dL), Suspected seizures E: Severe malformations: MMC, abdominal wall defects, atresia, cleft lip and palate, and others F: Prematurity <37 weeks of gestation: Prematurity <37 weeks of gestation
Exclusion criteria
Exclusion criteria: Newborns without any predefined trigger criterion. Births outside the participating maternity units. Newborns with missing or incomplete data required for the primary endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a hierarchical Desirability of Outcome Ranking (DOOR) endpoint, compared between intervention and control phases using a win ratio analysis. WHAT: Composite endpoint consisting of four hierarchically ranked dimensions: (1) death or severe early morbidity/escalation within 24 hours after birth, (2) early clinical stability at 10 minutes (Apgar score), (3) transfer/escalation of care (need for transfer and clinical status before transport measured by the TRIPS-II score [Transport Risk Index of Physiologic Stability]), (4) time to first involvement of a neonatal expert. WHEN: Dimension (1): within the first 24 hours of life Dimension (2): at 10 minutes (Apgar score) Dimension (3): during initial care until transfer decision / prior to transport Dimension (4): time interval from first clinical abnormality (trigger criterion) to first documented expert involvement HOW: Data are obtained from routine clinical care and medical records: Apgar score (standardized clinical scoring system), TRIPS-II score (Transport Risk Index of Physiologic Stability), documentation of escalation measures, interventions, and mortality, timestamps of clinical events and telemedical contacts. Evaluation follows a predefined hierarchical ranking of the DOOR components. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary endpoints have been defined. | — |
Countries
Germany
Contacts
Public ContactSven Wellmann
KinderUniKlinik Ostbayern (KUNO), Klinik St. Hedwig, Barmherzige Brüder Regensburg
Outcome results
None listed