Table 3.

Interview, Observation, Measurement, Test Administration, Health Record Transcription, and Biologic Specimen Collection According to Fetal/Infant Age

Data Collected	Research Visit
	Antenatal			Postnatal, mo
	Baseline	32 wk	Birth	1	3	6	12	18
Household composition, socioeconomic status	I					I		I
IYCF and WASH knowledge and practices	I/O			I/O	I/O	I/O	I/O	I/O
Maternal factors
Antenatal care, pregnancy exposures, PMTCT	I	I		I
Sick clinic visits and hospitalizations	I	I		I	I	I	I	I
Maternal capabilities	I					I		I
Maternal depression		T				T	T
Height	M
Weight, mid-upper arm circumference	M	M		M	M	M	M	M
Blood pressure	T	T
Biologic specimen collection, testing, and archival
Blood: HIV, CD4 (baseline), Hb, EED panel in substudiesa	All	All						All
Urine: Pre- and post-LM; spot for urinalysis/schistosomiasisb	All	All-spot
Stool: EED panel in substudies	All			EED
Saliva: cortisol	All
Infant factors
Delivery date, time, mode, place, complications, care, sex			R
Weight, length, head circumference			R	M	M	M	M	M
Immunizations and vitamin A			R	R/I	R/I	R/I	R/I	R/I
7-day and long-term morbidity, sick clinic visits, hospitalizations				I	I	I	I	I
Biologic specimen collection, testing, and archival
Blood: EED panel, HIV DNA PCR, Hbc				EED	EED	EED	EED	All
Urine: Pre- and post-LM test					EED	EED	EED	EED
Stool: EED panel				EED	EED	EED	EED	EED
Saliva					EED	EED	EED	EED

For specimen collections, All refers to all women and infants enrolled in the trial; EED refers to mother–infant dyads selected for EED substudy.

Abbreviations: EED, environmental enteric dysfunction; Hb, hemoglobin; HIV, human immunodeficiency virus; I, interview; IYCF, infant and young child feeding; LM, lactulose-mannitol; M, measurement; O, observation; PCR, polymerase chain reaction; PMTCT, prevention of mother-to-child transmission of HIV; R, transcription from medical record; T, test; WASH, water, sanitation, and hygiene.

^a EED Panel includes assays which assess causal pathways of EED and anemia. Planned assays are listed below though final choice of biomarkers may change depending on emerging data. Blood/Serum/Plasma: α-1 acid glycoprotein; C-reactive protein; intestinal fatty acid binding protein; insulin-like growth factor 1; activation levels of T-cells by flow cytometry; soluble transferrin receptor; hemoglobin; Urine: lactulose-mannitol ratio; Feces: myeloperoxidase, α-1-antitrypsin; neopterin; regenerating protein 1B; composition and function of intestinal microbiota.

^b A single-void urine sample (spot sample) is collected from all women at baseline and at 32 gestational weeks for urinalysis using Multistix test strips in the homestead and for urinary microscopy for ova of Schistosoma hematobium in the field laboratory. At baseline, an LM test is additionally conducted in all women. Prior to ingestion of LM solution, a pre-LM single-void urine sample is collected to measure baseline mannitol by mass spectrometry; after ingestion of LM solution, all urine is collected over a 2-hour period (LM urine), preserved with chlorhexidine and measured, then aliquots frozen at −80°C for subsequent analysis of lactulose and mannitol recovery by mass spectrometry.

^c Hemoglobin is not measured at 1 month of age.