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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