apnea of prematurity
Conditions
Interventions
test group:Caffeine use within 6 hours after birth
control group:The original clinical treatment plan remains unchanged (or 12 hours after birth) using caffeine
Sponsors
Pediatric Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1.27 weeks < gestational age < 32 weeks
Exclusion criteria
Exclusion criteria: 1. Died within 24 hours of admission or gave up treatment within 24 hours after taking medication; 2. Severe liver and kidney insufficiency, cardiac insufficiency; 3. Preterm infants with severe congenital malformations or congenital developmental abnormalities, congenital metabolic disorders, and chromosomal abnormalities; 4. Severe apnea or bradycardia 10 minutes before birth requires emergency tracheal intubation; 5. Children whose family members refuse or the attending doctor on duty thinks they are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of endpoint outcome events (death or IVH or cystic or diffuse PVL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of apnea within 72 hours of medication;Length of hospital stay, duration of respiratory support, and duration of oxygen use;Changes in cerebral cortical activity and cerebral blood oxygen during drug injection;death during hospitalization;Ultrasound-confirmed III-IV intracranial hemorrhage;Qualitative scoring of white matter and gray matter abnormalities by brain magnetic resonance imaging in stable stage;12-18 months neurodevelopmental outcomes (GMs score), cerebral palsy (GMFCS score), cognitive impairment (MDI score);Neonatal Necrotizing Enterocolitis (NEC)/Bronchopulmonary Dysplasia (BPD)/Retinopathy of Prematurity (ROP) / Incidence of Patent Ductus Arteriosus (PDA);Drug Safety Indicators; | — |
Countries
China
Contacts
Public ContactLaishuan Wang
Pediatric Hospital Affiliated to Fudan University
Outcome results
None listed