Study Outcome | Method/Samples | Randomization | Close-Out | ||||
---|---|---|---|---|---|---|---|
≤ 120 | 180* | 240* | 270* | 365* | 730* | ||
ENROLLMENT: | |||||||
Eligibility Screen | X | ||||||
Informed Consent | X | ||||||
Randomization | X | ||||||
STUDY GROUPS: | |||||||
Standard formula (SF) | X | X | X | X | X | X | |
Experimental formula (EF) | X | X | X | X | X | X | |
Human milk Reference (HM) | X | X | X | X | X | X | |
ASSESSMENTS: | |||||||
Parent/Family | |||||||
Sociodemographics | Questionnaire | X | |||||
Family History | Questionnaire | X | |||||
Maternal obstetric history | Questionnaire/Clinical Record | X | |||||
Parental Height | Stadiometer | X | |||||
Parental Weight | SECA Scale | X | X | X | X | ||
Parental Waist Circumference | Circumference Tape | X | X | X | X | ||
All participants | |||||||
APGAR score | APGAR test | X | |||||
Clinical history | Clinical record | X | X | X | X | ||
Length/Height | Stadiometer | X | X | X | X | X | |
Weight | SECA scale | X | X | X | X | X | |
Head Circumference | Circumference Tape | X | X | X | X | X | |
Mid Upper Arm Circumference | Circumference Tape | X | X | X | X | X | |
Dietary Assessment | 24-Hr Recall Questionnaire | X | X | X | X | ||
Medically confirmed AEs | Phone calls | ||||||
Protocol compliance | Phone calls | ||||||
Participant Subset 1 | |||||||
Body composition | PeaPod® | X | X | ||||
Deuterium Dilution | X | X | |||||
Micronutrient Status | Fasting venous sample | X | X | X | X | ||
Metabolic Markers | Fasting venous sample | X | X | X | X | ||
Serum Phospholipids | Fasting venous sample | X | X | ||||
Cognitive performance | Bayley-III, Cognitive Scale | X | |||||
Participant Subset 2 | |||||||
Sleep Pattern | Actigraphy | X | X | X | |||
BISQ | X | X | X | ||||
ERP | Dense array Electroencephalography | X | X | ||||
Participant Subset 3 | Native Phoneme | X | X | ||||
Word Discovery | X | ||||||
Rule Inference | X | ||||||
CDI | X | X |