A study evaluating the safety and efficacy of an experimental drug for chronic lung disease against normally prescribed care in extremely premature babies

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 477

Inclusion Criteria

1. Written informed consents must be signed and dated by the subject's parent(s), if age 16 or older, prior to any study-related procedures. For parent(s) under the age of 16, written informed consents and assents must be signed and dated by the subject's parent(s) or legally authorized representative(s), if applicable, prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).
2. Written informed consents must be signed and dated by the subject's birth mother, if age 16 or older, prior to any study-related procedures. For birth mothers under the age of 16, written informed consents and assents must be signed and dated by the subject's birth mother and her legally authorized representative(s), if applicable, 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.
3. Initially, subjects must be between GA of 26 weeks +0 days and 27 weeks +6 days, inclusive. After approximately 75 subjects (approximately 25 subjects in each treatment group) have completed the PMA 40 weeks visit, an independent DMC will assess safety data and may authorize enrollment of subjects of GA between 23 weeks +0 days and 27 weeks +6 days, inclusive.
Are the trial subjects under 18? yes
Number of subjects for this age range: 477
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion 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 investigator’s 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 cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and
investigator’s opinion.
5. Any other condition or therapy that, in the investigator’s opinion, may pose a risk to the subject or interfere with the subject’s potential compliance with this protocol or interfere with interpretation of results.
6. Current or planned participation in a clinical study of another investigational study drug, device, or procedure (participation in observational studies is permitted on a case-by-case basis).
7. The subject or subject’s parent(s) or legally authorized representative(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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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