Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Time to Establish Full Enteral Feeds |
The age of the infants in days when the infant receive 150 ml/kg/day via enteral feeding for the first time. |
Birth to gestational week 36+0 |
|
Secondary |
Days With Halted Feeding Due to Food Intolerance |
Episode with food intolerance. Retention volume> food volume given the last 2 hours (retention checked routinely every 4 hours) and/or clinical signs consistent with necrotizing enterocolitis (reduced general condition and inflated abdomen). The number of such events will also be indicated. |
Birth to gestational week 36 |
|
Secondary |
Number of Stools |
|
Recorded over the first four weeks |
|
Secondary |
Time Until Birth Weight is Regained. Specifies the Number of Full Days the Child Has Lived. |
Specifies the number of full days the child has lived. |
Birth to gw 36+0 |
|
Secondary |
Weight Gain (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At 14th day of life |
|
Secondary |
Mortality |
|
Birth to gw 36+0 |
|
Secondary |
Necrotizing Enterocolitis |
Bell´s criteria II-III |
Birth to gw 36+0 |
|
Secondary |
Sepsis |
Blood culture positive sepsis |
Birth to gw 36+0 |
|
Secondary |
Bronchopulmonary Dysplasia |
Need of oxygen or CPAP/ventilator at gw 36+0 |
Gw 36+0 |
|
Secondary |
Weight Gain (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At 28th day of life |
|
Secondary |
Weight Gain (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At gestational week 36+0 |
|
Secondary |
Length Gain (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At 14th day of life |
|
Secondary |
Length Gain (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At 28th day of life |
|
Secondary |
Length Gain (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At gestational week 36+0 |
|
Secondary |
Head Circumference Growth (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At 14th day of life |
|
Secondary |
Head Circumference Growth (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At 28th day of life |
|
Secondary |
Head Circumference Growth (SD) |
In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict. |
At gestational week 36+0 |
|
Secondary |
Neurological Development |
Bayleys´s test by psychologist |
At 2 years corrected age |
|
Secondary |
Neurological Development Impairment |
A composite of several outcomes: impaired cognition at the Bayleys´test, cerebral palsy, blindness and deafness, divided into normal, mild, moderate and severe. Mild -1SD to -2SD, Moderate <-2D to 3 SD and Severe <3SD |
At 2 years corrected age |
|