Introduction and enrollment summary

This document provides an automated summary of data entered from ELICIT. It is generated from a dataset built from the MuSIC server and is updated several times each week. These data lag the actual collected data by roughly one week (for the primary forms) and in some cases longer (e.g. for labs that have a longer turnaround time). Also, because data quality is being monitored, with corrections made and missing data added, there can be some variance in the data from day to day even if new subjects have not been added.

As of today, inital assessment data from 939 children have been entered (this includes 20 children who were ultimately not eligible)

The number of children with initial assessment data entered by week since enrollment began is as follows:

Eligibility

Of the 20 children who were not eligible, 3 did not consent to participation, 7 expected to move from the study area, 1 had a mother with age < 18, 2 were from a multiple pregnancy, 2 children were not healthy at the time of assessment, 0 had a child weight less than 1.5kg, and 0 already had a child enrolled in ELICIT. Additionally, 19 children dropped out of the study. NA died.

This leaves 902 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 226) Group 2 (n = 227) Group 3 (n = 228) Group 4 (n = 221)
child age (days) 5.6 +/- 7.2 5.7 +/- 6.6 5.7 +/- 6.2 5.4 +/- 6.7
# male sex (%) 112 (49.6%) 114 (50.2%) 121 (53.1%) 111 (50.2%)
# born in hospital (%) 126 (55.8%) 120 (52.9%) NA (NA%) 106 (48%)
Median family income 30000 (min: 4000, max: 5e+05) 40000 (min: 10000, max: 4e+05) 30000 (min: 5000, max: 360000) 30000 (min: 1500, max: 3e+05)
Mother with >= 7 years of education (%) 163/205 (79.5%) 147/210 (70%) 156/212 (73.6%) 154/205 (75.1%)
# Iraqw 167/205 (81.5%) 178/210 (84.8%) 166/212 (78.3%) 160/205 (78%)
maternal age (years) 27.5 +/- 7.2 28 +/- 6.6 27.7 +/- 6.2 27.3 +/- 6.7
enrollment length (cm) 49.2 +/- 2.1 min:42.2 max: 59 48.6 +/- 3.6 min:5.7 max: 56 49.1 +/- 2.1 min:42 max: 55 49.1 +/- 2.2 min:38 max: 57
enrollment weight (kg) 3.1 +/- 0.5 min:1.8 max: 4.6 3.1 +/- 0.4 min:1.9 max: 4.3 3.1 +/- 0.5 min:1.6 max: 4.4 3.1 +/- 0.5 min:1.9 max: 5.7
enrollment head circumference (cm) 34.6 +/- 1.3 min:31 max: 38 34.5 +/- 1.3 min:30 max: 38.4 34.8 +/- 1.3 min:31 max: 38 34.7 +/- 1.3 min:31.4 max: 37.5

Illness, access to healthcare, and antibiotic use

Access to healthcare in last week by child age and nicotinamide treatment assignment:

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Illness in the last week by child age and nicotinamide treatment assignment:

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Antibiotic use in the last week by child age and nicotinamide treatment assignment:

Adverse events in mothers

To date, there have been 219 adverse events in mothers (119 in NIC-A and 100 in NIC-B). There have been 22 serious adverse events (13 in NIC-A and 9 in NIC-B) and 0 adverse events deemed related or possibily related to study medications (0 in NIC-A and 0 in NIC-B).

Serious adverse event categories in mothers by nicotanimde arm:

NIC-A NIC-B
Any Serious AE NA (NA%) 9 (9%)
diarrhea 3 2
DVT 1 0
Lab abnormality 1 3
Other 8 4

The “other” serious AEs for NIC-A were as follows: EPILEPSY, UNSPECIFIED GASTROINTESTINAL ILLNESS, ACUTE ASTHMATIC ATTACK, PARTIAL INTESTINAL OBSTRUCTION, PARTIAL INTESTINAL OBSTRUCTION, PARTIAL INTESTINAL OBSTRUCTION, 1. UNSPECIFIED ILLNESS 2. SYPHILIS, UNSPECIFIED ILLNESS

The “other” serious AEs for NIC-B were as follows: POSTPARTUM PRE ECLAMPSIA, PEUPERAL SEPSIS, SCHIZOAFFECTIVE DISORDER, SUSPECTED ORGANOPHOSPHATE POISONING

Adverse events in children

To date, there have been 794 adverse events in children (402 in NIC-A and 392 in NIC-B). There have been 65 serious adverse events (32 in NIC-A and 33 in NIC-B) and 0 adverse events deemed related or possibily related to study medications (0 in NIC-A and 0 in NIC-B).

Adverse events in children by nictonamide arm:

NIC-A NIC-B
Any Serious AE NA (NA%) NA (NA%)
ALRI 15 16
diarrhea 1 2
Lab abnormality 5 1
neonatal sepsis 7 9
Other 1 4
URTI 3 1

The “other” serious AEs for NIC-A were as follows: SEPSIS

The “other” serious AEs for NIC-B were as follows: ABSCESS ON THE RIGHT BREAST, SYMPTOMATIC UTI, NEONATAL JAUNDICE, NEONATAL JAUNDICE

Protocol deviations by nicotanmide arm

NIC-A NIC-B
Any protocol deviation 46 53
Inappropriate documentation of consent 0 1
Study medication given outside of time window 9 9
Incorrect does of study medication 3 4
Delay of AE/SAE reporting 7 15
Blood for safety labs at 2 months (first 100 participants) not obtained 26 24

Compliance with study medications

Objective nicotanimide pill compliance (based on pill counting performed every 2 months starting at the 2 month visit):

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Subjective nicotanimide pill compliance (basd on maternal report of pills consumed in the previous 7 days at each monthly visit):

Breastfeeding status

Prevalence of breastfeeding as primary source of food by child age in months and nicotinamide treatment assignment:

Prevalence of exclusive breastfeeding by child age in months and nicotinamide treatment assignment: