TIBC-II: 2-Iminobiotin versus standard care in neonates with perinatal asphyxia in Kinshasa (DR Congo)
Phase 2
- Conditions
- Neonatal Diseases
- Registration Number
- PACTR202308870380725
- Lead Sponsor
- niversity Clinics Kinshasa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
1. Newborns with = 36 weeks gestation with moderate to severe perinatal asphyxia with a Thompson score = 7 and < 16 within 6 hours of birth
2. Possibility to start treatment within 6 hours after birth
Exclusion Criteria
1.Inability to insert an umbilical venous catheter or peripheral infusion for study medication administration.
2.Major congenital or chromosomal abnormalities, such as diaphragmatic hernia, omphalocele, trisomy 13 or trisomy 18
3.Birth weight< 1800 grams
4.Obvious signs of infection
5.Moribund patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy - The number of surviving patients with aEEG (Continuous Normal Voltage (CNV)) 36 hours after birth
- Secondary Outcome Measures
Name Time Method Safety - Vital signs (heart rate, respiratory rate and non-invasive blood pressure) ;Safety - Vital signs (heart rate and respiratory rate);Safety - Need for intervention for respiratory and circulatory reasons ;Safety - The occurrence of (serious) adverse events;Efficacy - Thompson score ;Efficacy - The number of surviving patients with normal aEEG (CNV) ;Efficacy - The number of patients with CNV or Discontinuous Normal Voltage (DNV) ;Efficacy - The number of patients with a sleep-wake cycle (SWC) ;Efficacy - The time it takes for CNV, DNV and SWC ;Efficacy - Presence of clinical seizures;Efficacy - Epileptic burden of (sub)clinical seizures (observed by aEEG) and presence of epileptic status;Efficacy - Use of anticonvulsant medications needed to control seizures;Efficacy - Mortality at 7 days;Efficacy - The ability to drink at 7 days after birth or at discharge from the hospital