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van CCT (UK)


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van CCT (UK)


Double-blind, parallel, randomised study to investigate the effect of an energy- and protein-enriched formula on whole body protein turnover, substrate utilization, growth and tolerance in mechanically ventilated, critically ill infants.


- candidate number1802
- NTR NumberNTR515
- ISRCTNIncomplete data for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-nov-2005
- Secondary IDsN/A 
- Public TitleDouble-blind, parallel, randomised study to investigate the effect of an energy- and protein-enriched formula on whole body protein turnover, substrate utilization, growth and tolerance in mechanically ventilated, critically ill infants.
- Scientific TitleDouble-blind, parallel, randomised study to investigate the effect of an energy- and protein-enriched formula on whole body protein turnover, substrate utilization, growth and tolerance in mechanically ventilated, critically ill infants.
- ACRONYMInfatrinistudie
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-jan-2003
- planned closingdate31-dec-2005
- Target number of participants24
- InterventionsEnergy and protein enriched enteral feeding; Infatrini (Nutricia, Zoetermeer, The Netherlands).
- Primary outcome1. 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 outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. D.A Waardenburg van
- CONTACT for SCIENTIFIC QUERIESDrs. D.A Waardenburg van
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryAdequate 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.
- Main changes (audit trail)
- RECORD1-nov-2005 - 13-sep-2010


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