None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 1 week – 12 months At term, or born pre-term (before 37 completed weeks of gestation) but > 40 weeks post-conceptional age; 2. Primary admitted to or referred to the Paediatric Intensive Care Units (PICU) of the :1) Sophia Children’s Hospital or 2) University hospital Maastricht; 3. Respiratory insufficiency due to respiratory disease (viral or bacterial pneumonia); 4. Possibility to start study within 24 hours after admission; 5. Mechanical ventilation; 6. Expected length of stay >72 hours; 7. Exclusively formula-fed; 8. Naso-duodenal/gastric feeding during the study period; 9. No contra-indication for enteral nutrition Haemodynamic stable condition (normal, stable blood pressure and normal renal function); 10. One venous and one arterial line present; 11. Written informed consent from a parent or legal guardian.
Exclusion criteria
Exclusion criteria: 1. Simultaneous participation in another clinical study with interventions that may influence the end points of this trial; 2. Breastfeeding; 3. Known chromosomal disorder; 4. Congenital GI obstructions (duodenal atresia, anal atresia etc.), congenital metabolic disease, abnormal liver or kidney function tests, active upper GI bleeding or postoperative ileus; 5. At risk for intestinal ischaemia (to the judgement of the paediatric intensivist – including hypoxia and shock).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Whole body protein metabolism on day 4; 2. Rate of protein synthesis; 3. Rate of protein breakdown; 4. Rate of protein oxidation; 5. Rate of net nitrogen accretion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Differences in energy and substrate utilization (indirect calorimetry); 2. Gastric retentions as a measure of tolerance of the different feedings; 3. Protein and caloric intake achieved on on day 4; 4. Growth on day 4 and 7; 5. Weight gain; 6. Length gain (knee-heel length); 7. Skinfold + arm circumference. | — |