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Table 3 Data variables

From: The NICU Antibiotics and Outcomes (NANO) trial: a randomized multicenter clinical trial assessing empiric antibiotics and clinical outcomes in newborn preterm infants

Data variables for data collection form

Maternal

Demographics

DOB, race, highest education level

Lifestyle

Tobacco and alcohol use, BMI

Current pregnancy history

Final antepartum admission date, number of fetus(es), prenatal obstetrics visit, history of spontaneous preterm birth

Diagnoses (Yes/No)

Insulin-dependent diabetes, maternal hypertension, preeclampsia, antepartum hemorrhage, placenta previa, abruptio placenta, fetal growth restriction, cervical insufficiency, preterm labor

Antibiotics administered within 30 days of delivery

Diagnoses: positive urine cultures, genital tract infection, skin/soft tissue infection, vaginal yeast infection, PPROM, GBS, presumed or confirmed intraamniotic infection or chorioamnionitis; drug names, length of treatment

Other drugs

Tocolytic therapy, betamethasone, antenatal corticosteroids; drug names, length of treatment

Infant baseline

Delivery

Date, time, gestational age, sex, birth weight (kg)

Randomization

Date

Infant hospital course

Outcomes at 1 week of age

EOS diagnosis

1. If Yes: causative organism, antibiotics and dates of treatment

Days of antibiotics received during week 1 of life

Weekly

Weight (kg), length (cm), LOS diagnosis (Yes/No), NEC diagnosis (Yes/No), death (Yes/No)

Nutrition (days 3, 7, 14, 28, 60)

Enteral nutrition, type of milk or formula received, date subject reached full enteral feedings

Discharge

Date of discharge, culture results, diagnoses: Grade 3 or 4 IVH, ROP, CLD, days of endotracheal intubation, positive blood cultures, positive respiratory cultures, positive urine cultures, positive cerebrospinal fluid cultures

Antibiotics prescribed

Diagnosis, drug name, total number of days administered

IV antifungal medications

Total number of days prescribed