TIBC-II: 2-Iminobiotin versus standard care in neonates with perinatal asphyxia in Kinshasa (DR Congo)
Phase 2
Not yet recruiting
- 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of 2-iminobiotin improve outcomes in neonatal asphyxia?
How does 2-iminobiotin compare to standard-of-care treatments for perinatal asphyxia in low-resource settings?
Are there specific biomarkers that predict neonatal response to 2-iminobiotin therapy in perinatal asphyxia?
What are the known or potential adverse events associated with 2-iminobiotin treatment in preterm and term neonates?
What other compounds or combination therapies are being explored for moderate to severe perinatal asphyxia in sub-Saharan Africa?