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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT01208493
Eligibility Criteria:
Inclusion Criteria:
* Gestational age \<32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof
* Birth weight ≤1500 g
* Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h
* Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved
* In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl
* Written informed consent has been obtained from the legal representative
Exclusion Criteria:
* Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days
* Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography
* Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine
* Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture
* Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3)
* Hepatic dysfunction: defined by jaundice (direct bilirubin \>1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT)
* Lung disease, severe enough to require steroid therapy.
* Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age.
* Participation in another clinical trial that may affect outcomes of this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
10 Weeks
Study:
NCT01208493
Study Brief:
Protocol Section:
NCT01208493