No registrations found.
ID
Source
Brief title
Sponsors and support
<br><br>
Participants Nutricia Netherlands:
Mrs. C. Kleijer Nutricia Netherlands, Scientific Services
P.O. Box 1
2700 MA Zoetermeer, The Netherlands
Tel: 0031-79-3539205/452
E-mail: chantal.kleijer@nutricia.nl
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Adequate nutrition is essential part of threatment of critically ill infants and children but often receives little attention in the acute phase of the disease. Undernutrition however is present in 15-20% of all children admitted to pediatric intensive cares. Undernutrition is associated with decreased woundhealing, decreased immunefunction and increased mortality and morbidity. Requirements of critically ill infants and children are not known.
In the present study we investigate the requirement of these children by comparing an energy and protein enriched infant formula (Infatrini, Nutricia, Zoetermeer, The Netherlands) with the standard infant formula (Nutrilon 1, Nutricia, Zoetermeer Netherlands) during 7 days in a randomised double blind manner. Our hypothesis is that the protein and energy enriched formula has positive effects on protein metabolism (as measured with stable isotope methods on the 4th day of enteral nutrition), substrate utilization (daily indirect calorimetry), and growth (body weight, knee-heel length, skinfolds day 1, 4 and 7)) during critical illness and does not lead to overfeeding gewichtsgroei.
Study objective
The hypothesis is that increasing energy and protein intake in these children will stimulate the rate of protein synthesis, decrease the rate of (muscle)protein breakdown, lead to increased net protein accretion, avoids weight loss and promotes growth. The second hypothesis is that it will be well tolerated by these infants and not lead to sign and symptoms of overfeeding. Also the caloric intake achieved with these feeding regimen compared to the energy expenditure will be assessed.
Study design
N/A
Intervention
Energy and protein enriched enteral feeding; Infatrini (Nutricia, Zoetermeer, The Netherlands).
Department of Paediatrics,
Paediatric Intensive Care
[default]
The Netherlands
+31-43-3875245
d.vanwaardenburg@paed.azm.nl
Department of Paediatrics,
Paediatric Intensive Care
[default]
The Netherlands
+31-43-3875245
d.vanwaardenburg@paed.azm.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL474 |
| NTR-old | NTR515 |
| Other | : N/A |
| ISRCTN | Incomplete data for ISRCTN |