TIBC-II FU Study: Follow-up study of 2-Iminobiotin versus standard care in newborns with perinatal asphyxia in Kinshasa, DR Congo

Follow-up TIBC-II Follow-up study of the multicenter Phase II trial comparing the efficacy of 2-iminobiotin (2-IB) treatment with standard care in newborns =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

PACTR202505604153688

Enrollment

Registered

2025-05-27

Start date

2024-08-16

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: All patients who were included in the TIBC-II study.

Exclusion criteria

Exclusion criteria: Lack of informed consent

Design outcomes

Primary

Measure	Time frame
Survival with a normal outcome is defined as a mental development index score = 85 for BSID-III, a GMFCS 0, freedom from blindness or hearing loss (> 40 dB), and/or epilepsy at 24 months of age.	—

Secondary

Measure	Time frame
The occurrence of Serious Adverse Events (SAEs) ;Mortality: the rate of death ;Severe neurodevelopmental impairment the incidence of severe neurodevelopmental impairment, defined as a Mental Development Index score 90 dB) requiring amplification and/or epilepsy requiring antiepileptic medications.;Moderate neurodevelopmental impairment: the incidence of moderate neurodevelopmental impairment, defined as a Mental Development Index score 40 dB) ;Moderate and severe neurodevelopmental death or impairment : incidence of moderate and severe neurodevelopmental death or impairment ;Death or severe neurodevelopmental impairment: the incidence of death or severe neurodevelopmental impairment;Normal Outcome ;The incidence of abnormal GMA at 3 months of age, defined as the absence of agitated movements or the presence of a cramped synchronized pattern ;The incidence of abnormal ASQ outcome, defined as a loss of at least 15% on the total ASQ score.;The impact of a mental development index score 40 dB) or severe (90 dB) bilateral hearing loss;The incidence of cerebral visual impairment;The growth rate	—

Measure

Time frame

The occurrence of Serious Adverse Events (SAEs) ;Mortality: the rate of death ;Severe neurodevelopmental impairment the incidence of severe neurodevelopmental impairment, defined as a Mental Development Index score 90 dB) requiring amplification and/or epilepsy requiring antiepileptic medications.;Moderate neurodevelopmental impairment: the incidence of moderate neurodevelopmental impairment, defined as a Mental Development Index score 40 dB) ;Moderate and severe neurodevelopmental death or impairment : incidence of moderate and severe neurodevelopmental death or impairment ;Death or severe neurodevelopmental impairment: the incidence of death or severe neurodevelopmental impairment;Normal Outcome ;The incidence of abnormal GMA at 3 months of age, defined as the absence of agitated movements or the presence of a cramped synchronized pattern ;The incidence of abnormal ASQ outcome, defined as a loss of at least 15% on the total ASQ score.;The impact of a mental development index score 40 dB) or severe (90 dB) bilateral hearing loss;The incidence of cerebral visual impairment;The growth rate

—

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