Footprints Study

JRCT ID: jRCT2031240339

Registered date:17/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: BPD, CLD, Intraventricular Hemorrhage, Retinopathy of Prematurity
• Date of first enrollment: 30/09/2024
• Target sample size: 14
• Countries of recruitment: Finland,Japan,Germany,Japan,Ireland,Japan,Italy,Japan,Netherlands,Japan,Portugal,Japan,Spain,Japan,UK,Japan,Canada,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Participants will receive continuous IV infusion of OHB-607 through from birth up to postmenstrual age (PMA) 29 weeks +6 days.

Outcome(s)

• Primary Outcome: Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (+- 3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA, whichever comes first as compared to the standard neonatal care (SNC) group.

Key inclusion & exclusion criteria

• Age minimum: >= 23weeks old
• Age maximum: < 28weeks old
• Gender: Both

Include criteria

1.Written informed consents and/or assents must be signed and dated by the subject's parent(s) prior to any study-related procedures. The informed consent and any assents for underageparents must be approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) (in accordance with local regulations).
2.Written informed consents and/or assents must be signed and dated by the subject's birth mother prior to providing study-related information related to birth mother medical history, pregnancy, and the birth of the subject. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
3.Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

Exclude criteria

1. Detectable major (or severe) congenital malformation identified before randomization.
2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigators opinion.
3. Hypoglycemia at baseline (blood glucose <45 mg/dL or 2.5 mmol/L) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
4. Clinically significant neurological disease identified before randomization according to CUS (hemorrhages confined to the germinal matrix are allowed) and investigators opinion.
5. Any other condition or therapy that, in the investigators opinion, may pose a risk to the subject or interfere with the subjects potential compliance with this protocol or interfere with interpretation of results.
6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
7. The subject or subjects parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.

Related Information

• Primary Sponsor: Furuzono Hiroshi
• Secondary ID(s): NCT03253263,2018-001393-16