P07
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Premature birth before completion of the 37th week of pregnancy and inpatient stay in the Neonatology and Paediatric Intensive Care Unit of the Department of Operative and Conservative Paediatrics and Adolescent Medicine, Paediatrics II, University Hospital Halle
Exclusion criteria
Exclusion criteria: - Congenital anomalies: chromosomal abnormalities, congenital cyanotic heart disease and anomalies of the gastrointestinal system - Metabolic diseases, kidney, liver or endocrine disorders - Severe genetic disorders that impair growth or neurological development - Incurable diseases in which life-sustaining measures have been limited or withheld - Cerebral haemorrhages of grade III or higher - Abdominal surgery leading to malabsorption, e.g. involving intestinal resection - Surgery due to necrotising enterocolitis with intestinal resection - Surgery due to congenital anomalies with intestinal resection, e.g. Hirschsprung's disease, small bowel atresia or oesophageal atresia - Surgery due to mechanical ileus, volvulus or intussusception with bowel resection - Surgery due to spontaneous intestinal perforation - Multiple abdominal surgeries, e.g. in cases of complicated omphalocele repair or stoma repair in Hirschsprung's disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints to be recorded are the body weight (in kilograms), body length (in centimeters), and head circumference (in centimeters) of the patients upon discharge from the ward to their homes, and the individual time (in days) until the calculated birth percentile is reached. All data should be taken from the respective patient charts. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following data should be recorded as secondary endpoints: - The time (in days) until full nutritional intake is achieved, defined as one sixth of body weight (in kilograms) per day - Whether separate calcium and phosphate supplementation was necessary during the inpatient stay and the respective duration of such supplementation (in days) - Whether bronchopulmonary dysplasia occurred during hospitalisation - Whether necrotising enterocolitis occurred during hospitalisation - Whether hyperglycaemia of > 8 mmol/l (145 mg/dl) occurred during hospitalisation - Whether insulin was required (start of insulin therapy from blood sugar levels > 10 mmol/l) during the hospital stay - The neural development of patients two years after birth (using BSID III) All data should be taken from the patient's respective curve, the doctor's letter about the inpatient stay, and the written documentation about the BSID III. | — |
Countries
Germany
Contacts
Martin-Luther-Universität Halle-Wittenberg