TIBC-II: 2-Iminobiotin versus standard care in neonates with perinatal asphyxia in Kinshasa (DR Congo)

TIBC-II: Multicenter phase II trial comparing efficacy of 2-iminobiotin (2-IB) treatment with standard care in neonates =36 weeks gestational age with moderate to severe perinatal asphyxia in Kinshasa, DR Congo

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202308870380725

Enrollment

Registered

2023-08-30

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases

Interventions

2 iminobiotin

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Efficacy - The number of surviving patients with aEEG (Continuous Normal Voltage (CNV)) 36 hours after birth	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Democratic Republic of the Congo

Contacts

Public ContactTherese Biselele

Department of Pediatrics Neonatology University Clinics of Kinshasa

therese.biselele@unikin.ac.cd+243895082997

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026