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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24240
Enrollment
24
Registered
2005-11-01
Start date
2003-01-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Energy and protein enriched enteral feeding
Infatrini (Nutricia, Zoetermeer, The Netherlands).

Sponsors

Nutricia Netherlands 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
Lead Sponsor

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

MeasureTime 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

MeasureTime 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.

Contacts

Public ContactD.A Waardenburg van
d.vanwaardenburg@paed.azm.nl+31-43-3875245

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)