Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT00854633
Eligibility Criteria:
Inclusion Criteria:
* Birth weights ranging from 750 to 1500 grams
* Entry before 24 hours of age
* Informed-consent form signed by parent(s) or legal guardian
* Able to take liquid medication by mouth or feeding tube
Exclusion Criteria
* A major birth defect or malformation syndrome
* Chromosomal or inherited disorder
* Proven presence of an immunodeficiency
* Antenatal exposure to illicit substances
* Birth asphyxia
* HIV or other congenital viral, bacterial, or fungal infection
* Lack of parental consent or refusal of attending neonatologist to allow participation
* Discretion of the investigator
* The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
24 Hours
Study:
NCT00854633
Study Brief:
Protocol Section:
NCT00854633