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: A

Sex: All

Target Recruitment: 477

Inclusion 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 underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).
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.
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) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.

Major (or severe) congenital malformations include structurally significant congenital heart disease, and structural abnormalities of the upper airway, lungs or chest wall. Congenital malformations that are suspected of being associated with chromosomal abnormalities, genetic syndromes, and neoplasia should be excluded, as well as abnormalities that may affect life expectancy, cardio-pulmonary development, neurologic development, or
interpretation of study results.

Isolated minor dysmorphic anomalies that are unlikely to be exclusionary could include post-axial polydactyly, ankyloglossia, accessory nipples, preauricular pits, single or horizontal palmar crease, clinodactyly, and single umbilical artery. However, the presence of multiple minor anomalies in the same infant may be exclusionary.

Uncomplicated infantile hemangiomas are unlikely to be exclusionary. However, infantile hemangiomas that may be associated with potential for disfigurement, life-threatening complications, functional impairment, ulceration, or underlying abnormalities should be excluded.
Inclusion/exclusion will ultimately be determined by the investigator, based on assessment of the clinical presentation of each candidate subject and the likelihood that physical finding(s) are associated with a condition that impacts health and development.

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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