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 785 children have been entered (this includes 18 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 18 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, 1 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, 15 children dropped out of the study. NA died.

This leaves 752 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 189) Group 2 (n = 188) Group 3 (n = 189) Group 4 (n = 186)
child age (days) 5.5 +/- 7.3 5.1 +/- 6.7 5.3 +/- 6 5.2 +/- 6.4
# male sex (%) 93 (49.2%) 91 (48.4%) 95 (50.3%) 96 (51.6%)
# born in hospital (%) 100 (52.9%) 99 (52.7%) NA (NA%) 94 (50.5%)
Median family income 30000 (min: 5000, max: 5e+05) 30000 (min: 10000, max: 4e+05) 30000 (min: 5000, max: 360000) 30000 (min: 1500, max: 3e+05)
Mother with >= 7 years of education (%) 131/163 (80.4%) 108/160 (67.5%) 112/156 (71.8%) 117/158 (74.1%)
# Iraqw 130/163 (79.8%) 135/160 (84.4%) 120/156 (76.9%) 120/158 (75.9%)
maternal age (years) 28.2 +/- 7.3 28 +/- 6.7 27.7 +/- 6 27.8 +/- 6.4
enrollment length (cm) 49.3 +/- 2.2 min:42.2 max: 59 48.8 +/- 2.1 min:40 max: 53 49.2 +/- 2 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 +/- 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 +/- 1.4 min:30 max: 38 34.8 +/- 1.4 min:31 max: 38 34.7 +/- 1.3 min:31.5 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 147 adverse events in mothers (79 in NIC-A and 68 in NIC-B). There have been 18 serious adverse events (10 in NIC-A and 8 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%) 8 (11.8%)
diarrhea 3 2
DVT 1 0
Lab abnormality 1 3
Other 5 3

The “other” serious AEs for NIC-A were as follows: UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., 1. UTI, 2. VAGINA CANDIDIASIS, 3. UNSPECIFIED GASTROENTESTINAL ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, BREAST ENGORGEMENT., UNSPECIFIED ILLNESS, EPILEPSY, UNSPECIFIED ILLNESS, UNSPECIFIED RESPIRATORY ILLNESS., UNSPECIFIED ILLNESS, BREAST PAIN, UNSPECIFIED ILLNESS, UNSPECIFIED GASTROINTESTINAL ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, PEPTIC ULCERS, PEPTIC ULCER, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, ABSCESS, NA, UNSPECIFIED ILLNESS., UTI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, PARTIAL INTESTINAL OBSTRUCTION, PARTIAL INTESTINAL OBSTRUCTION, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UTI, PARTIAL INTESTINAL OBSTRUCTION, UNSPECIFIED ILLNESS , UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, ABSCESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., BREAST PAIN, UNSPECIFIED GASTROINTESTINAL ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS.

The “other” serious AEs for NIC-B were as follows: POSTPARTUM PRE ECLAMPSIA, UNSPECIFIED ILLNESS, UNKNOWN ILLNESS, 1. TOOTH FRACTURE 2. UNSPECIFIED ILLNESS, MASTITIS, MASTITIS, UNSPECIFIED ILLNESS, PEUPERAL SEPSIS, SCHIZOAFFECTIVE DISORDER, ASTHMA, DENTAL ABSCESS DUE TO DENTAL CARIES , UNSPECIFIED ILLNESS., CONJUCTIVITIS, UNSPECIFIED ILLNESS, MASTITIS, UNSPECIFIED ILLNESS, MASTITIS, PUD, UNSPECIFIED ILLNESS, MASTITIS, TOOTH ACHE, MASTITIS, EYE INJURY., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS , UNSPECIFIED ARTHRITIS , UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., PEPTIC ULCERS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS.

Adverse events in children

To date, there have been 499 adverse events in children (253 in NIC-A and 246 in NIC-B). There have been 43 serious adverse events (23 in NIC-A and 20 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 23 (9.1%) NA (NA%)
ALRI 8 7
diarrhea 1 1
Lab abnormality 5 1
neonatal sepsis 7 8
Other 1 3
URTI 1 0

The “other” serious AEs for NIC-A were as follows: UNSPECIFIED EAR INFECTION., UNSPECIFIED ILLNESS., GASTROINTESTINAL COLIC, PREUMONIA, CONJUNCTIVITIS AND COMMON COLD, SEPSIS, ABDOMINAL PAIN, UNSPECIFIED ILLNESS, ECZEMA, NONSPEFIC ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED GASTROINTESTINAL ILLNESS, UNSPECIFIED DISORDER OF BREAST , CONJUCTIVITIS., OTITIS MEDIA, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., NON- SPECIFIC SKIN ERUPTION., UTI, UNSPECIFIED ILLNESS, OPTHALMIC NEONATORUM., UNSPECIFIED GASTROINTESTINSL ILLNESS, UNSPECIFIED RESPIRATORY INFECTION, UNSPECIFIED ILLNESS., ABSCESS, ACUTE OTITIS MEDIA, UNSPECIFRED ILLNESS, UNSPECIFIED RESPIRATORY ILLNESS., INFANTILE IMPETIGO, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED EYE PROBLEM, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., UNSPECIFIED GASTROINTESTINAL ILLNESS, URTO, UNSPECIFIED RESPIRATORY ILLNESS, UNSPECIFIED RESPIRATORY ILLNESS

The “other” serious AEs for NIC-B were as follows: UNSPECIFIED ILLNESS, 1. GASTROENRITIS 2. UTI, NEONATAL ERYTHEMATOXIUM, DYSENTRY, UNSPECIFIED RESPIRATORY ILLNESS, CONSTIPATION, OPTHALMIC NEONATORUM, CONJUCTIVITIS, UNSPECIFIED RESPIRATORY ILLNESS, UTI, UTI, UNSPECIFIED ILLNESS, UNSPECIFIED GASTROENTESTINAL ILLNESS., SUBLAXATION OF LEFT LOWER LIMB., UNSPECIFIED ILLNESS, ABSCESS ON THE RIGHT BREAST, UNSPECIFIED RESPIRATORY ILLNESS., PARTIAL INTESTINAL OBSTRUCTION, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, CONGENITAL CYST, UNSPECIFIED RESPIRATORY ILLNESS., AIRI, ABSCESS, UNSPECIFIED GASTROINTESTINAL ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIC ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, ABSCESS, UNSPECIFIED ILLNESS, UNSPECIFIED GASTROINTESTINAL ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, NEONATAL JAUNDICE, UNSPECIFIED RESPIRATORY ILLNESS

Protocol deviations by nicotanmide arm

NIC-A NIC-B
Any protocol deviation 46 49
Inappropriate documentation of consent 0 1
Study medication given outside of time window 9 8
Incorrect does of study medication 3 3
Delay of AE/SAE reporting 7 15
Blood for safety labs at 2 months (first 100 participants) not obtained 26 22

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: