Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Days of feed intolerance |
Defined as number of days enteral feed was withheld for =>12 hours due to concerns about nasogastric aspirate colour or volume, vomiting, abdominal distension, stoma output, stooling or vomiting, as a proportion of the total number of days on which human milk-based breast milk fortifier was included in the feed |
At 38 weeks postmenstrual age (an average of 8 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of adverse events per infant related to the administration of human milk-based breast milk fortifier. |
Any adverse event felt to be directly related to the administration of human milk-based breast milk fortifier will be determined by the research team and the clinical team caring for the infant. |
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily Energy intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily protein intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily fat intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily carbohydrate intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily zinc intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily selenium intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily copper intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin A intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin D intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin E intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin C intake between surgery/gastrointestinal disturbance and discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily Energy intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily protein intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily fat intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily carbohydrate intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily zinc intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily selenium intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily copper intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin A intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin D intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin E intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Mean daily vitamin C intake whilst on human milk based fortifier |
|
During the intervention period (whilst receiving human milk-based fortifier, an average of 8weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Growth since study enrollment- weight gain in g/kg/day |
|
At 36 weeks postmenstrual age |
|
Secondary |
Growth since study enrollment- change in weight standard deviation score based on UK reference data |
|
At 36 weeks postmenstrual age |
|
Secondary |
Growth since study enrollment- weight gain in g/kg/day |
|
At Estimated date of delivery |
|
Secondary |
Growth since study enrollment- change in weight standard deviation score based on UK reference data |
|
At Estimated date of delivery |
|
Secondary |
Growth since study enrollment- weight gain in g/kg/day |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Growth since study enrollment- change in weight standard deviation score based on UK reference data |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Growth since study enrollment- weight gain in g/kg/day |
|
At 3 months of age corrected for prematurity |
|
Secondary |
Growth since study enrollment- change in weight standard deviation score based on UK reference data |
|
At 3 months of age corrected for prematurity |
|
Secondary |
Growth since study enrollment- length in mm/week |
|
At 36 weeks postmenstrual age |
|
Secondary |
Growth since study enrollment- change in length standard deviation score based on UK reference data |
|
At 36 weeks postmenstrual age |
|
Secondary |
Growth since study enrollment- length in mm/week |
|
At Estimated date of delivery |
|
Secondary |
Growth since study enrollment- change in length standard deviation score based on UK reference data |
|
At Estimated date of delivery |
|
Secondary |
Growth since study enrollment- length in mm/week |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Growth since study enrollment- change in length standard deviation score based on UK reference data |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Growth since study enrollment- length in mm/week |
|
At 3 months of age corrected for prematurity |
|
Secondary |
Growth since study enrollment- change in length standard deviation score based on UK reference data |
|
At 3 months of age corrected for prematurity |
|
Secondary |
Growth since study enrollment- head circumference in mm/week |
|
At 36 weeks postmenstrual age |
|
Secondary |
Growth since study enrollment- change in head circumference standard deviation score based on UK reference data |
|
At 36 weeks postmenstrual age |
|
Secondary |
Growth since study enrollment- head circumference in mm/week |
|
At Estimated date of delivery |
|
Secondary |
Growth since study enrollment- change in head circumference standard deviation score based on UK reference data |
|
At Estimated date of delivery |
|
Secondary |
Growth since study enrollment- head circumference in mm/week |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Growth since study enrollment- change in head circumference standard deviation score based on UK reference data |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Growth since study enrollment- head circumference in mm/week |
|
At 3 months of age corrected for prematurity |
|
Secondary |
Growth since study enrollment- change in head circumference standard deviation score based on UK reference data |
|
At 3 months of age corrected for prematurity |
|
Secondary |
Number of Episodes of Central Line Associated Blood Stream infection (CLABSI) and NEC during hospital stay after initial initial surgery/gastrointestinal disturbance, defined using existing nationally agreed case definitions |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Days of Parenteral Nutrition (PN) during hospital stay after initial initial surgery/gastrointestinal disturbance, defined as each 24hour period an infants received at least some PN |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Cost of providing PN per day during hospital stay after initial initial surgery/gastrointestinal disturbance |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of days spent having level 3 care (according to British Association of Perinatal Medicine criteria with associated tariff cost) during hospital stay after initial initial surgery/gastrointestinal disturbance |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of days spent having level 2 care (according to British Association of Perinatal Medicine criteria with associated tariff cost) during hospital stay after initial initial surgery/gastrointestinal disturbance |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of days spent having level 1 care (according to British Association of Perinatal Medicine criteria with associated tariff cost) during hospital stay after initial initial surgery/gastrointestinal disturbance |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of days spent having 'normal' care (according to British Association of Perinatal Medicine criteria with associated tariff cost) during hospital stay after initial initial surgery/gastrointestinal disturbance |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of participants who develop PN associated liver disease stay after initial surgery/GI disturbance-defined as cholestasis (conjugated serum bilirubin 34.2 mmol/L) occurring in the setting of PN, when other specific causes of liver injury excluded |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Length of stay in the hospital (both overall and post-operatively) |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of episodes of unplanned gastrointestinal surgery during hospital stay after initial initial surgery/gastrointestinal disturbance |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of infants that discontinue fortifier during hospital stay after initial initial surgery/gastrointestinal disturbance |
The number of infants who have the NeoKare fortifier stopped for clinical reasons. Reason for discontinuation will also be collected |
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of infants who die during the study period and prior to hospital discharge |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|
Secondary |
Number of episodes of any infections/sepsis requiring antibiotic therapy > 7 days during hospital stay after initial initial surgery/gastrointestinal disturbance |
|
At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance) |
|