Table 3 Description of outcomes with analysis metric, aggregation method, and time points in sub-cohort
Outcome variables sub cohort | |||
|---|---|---|---|
Outcome variables - feeding tolerance | Analysis metrics | Method of aggregation | Time point |
Enteral nutrition | Number of days until full enteral feeds | Mean/Median | During study intervention (until 34 weeks of gestational age) |
Parental nutrition | Number of days with parental nutrition | Mean/Median | During study intervention (until 34 weeks of gestational age) |
Interruptions of enteral nutrition | Number of enteral nutrition interruptions >8 h | Mean/Median | During study intervention (until 34 weeks of gestational age) |
Enteral nutrition decreased due to clinical instability | Number of EN decrease >50% | Mean/Median | During study intervention (until 34 weeks of gestational age) |
Use of breastmilk fortifiers | Number of days until breastmilk fortifiers is induced | Mean/Median | During study intervention (until 34 weeks of gestational age) |
Feeding tube requirement | Number of days requiring a feeding tube | Mean/Median | During study intervention and until 40 weeks of gestational age |
Macronutrient intake | Amount of macronutrients given (kcal/kg/day) | Mean/Median | During study intervention (until 34 weeks of gestational age) |
Micronutrient intake | Amount of micronutrients given (μg or mg/kg/day) | Mean/Median | During study intervention (until 34 weeks of gestational age) |
Outcome variables - postnatal growth | |||
Attaining birth weight | Number of days | Mean/Median | After attaining birth weight after normal initial weight loss postpartum |
Body weight | Kilograms | Mean/Median | 1. Once every week during study intervention 2. 40 weeks of gestational age 3. 3 months of corrected age 4. 12 months of corrected age 5. 2.5 years of corrected age 6. 5.5 years of age |
Body length | Centimeters | Mean/Median | 1. Once every week during study intervention 2. 40 weeks of gestational age 3. 3 months of corrected age 4. 12 months of corrected age 5. 2.5 years of corrected age 6. 5.5 years of age |
Head circumference | Centimeters | Mean/Median | 1. Once every week during study intervention 2. 40 weeks of gestational age 3. 3 months of corrected age 4. 12 months of corrected age 5. 2.5 years of corrected age 6. 5.5 years of age |
Growth chart Z-score | Standard deviation | 1. Once every week during study intervention 2. 40 weeks of gestational age 3. 3 months of corrected age 4. 12 months of corrected age 5. 2.5 years of corrected age 6. 5.5 years of age | |
Body composition | Fat mass, fat-free mass (%) | Average | 3 months corrected age |
Characteristics/covariates | |||
Use of medical steroids | Period of treatment | Mean/Median | From birth until 5.5 years of age |
Use of tetracyclines | Period of treatment | Mean/Median | From birth until 5.5 years of age |
Type of enteral nutrition mothers’ own milk, donated breastmilk, formula | Percentages (%) | Proportion | During study intervention (until 34 weeks of gestational age) |
Breastmilk fortification | Type | Proportion | During study intervention (until 34 weeks of gestational age) |
Breastfeeding at discharge | Full, partly, none | Proportion | Discharge from neonatal intensive care unit/homecare |