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Table 2 Measurements and visits conducted in ChiNuT

From: Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT)

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
  1. *All time points ± 14 days