No registrations found.
ID
Source
Brief title
Health condition
Preterm neonates, Premature infants, parenteral nutrition, tolerance
Sponsors and support
Intervention
Outcome measures
Primary outcome
Nitrogen balance
Secondary outcome
1. Safety of the nutritional regimen: as reflected by normal blood chemistry, no effect on hearing ability, no effect on chronic lung disease;
2. Growth: measured in terms of body weight, knemometry, head circumference, protein accretion and protein breakdown;
3. Fatty acid profile in plasma and erythrocytes;
4. Energy expenditure;
5. Short- and long-term outcome: days on mechanical ventilation, incidence of bronchopulmonary dysplasia, incidence of infection, intraventricular hemorrhage, and necrotizing enterocolitis, normal ALGO-test and Bayley III scores
Background summary
After birth, premature infants mainly depend on their limited endogenous stores and on parenteral nutrition for energy and growth. However, the optimal amounts and composition of the exogenous nutrients is not known. Recently, we demonstrated the beneficial effect of early amino acid (AA) supplementation on nitrogen balance, protein synthesis and redox state. Early lipid administration, in addition to amino acids and glucose, may be beneficial, since it provides energy for enhanced protein accretion and supplies essential fatty acids necessary for central nervous system development. With this study, we will quantify the effect of early parenteral lipid introduction and additional amino acid supplementation on protein accretion and growth, and determine possible adverse effects. Initiating total parenteral nutrition in an earlier stage after birth and in a different composition, as in this study, can further improve early postnatal outcome.
In addition we will compare different fat emulsions.
Study objective
Early lipid and extra amino acid administration is safe and effective and leads to improved short- and long-term outcome.
Study design
Most outcome measurements will be registered during the first week of
life (nitrogen balance, safety, fatty acid profile, protein metabolism
and energy expenditure), growth will be recorded during the first five
weeks of life, and general short- and long-term outcome will be recorded
until two years corrected age.
Intervention
Intervention group A will receive lipids from birth onwards. Interventiongroup B will receive extra amino acids in combination with lipids from birth onwards. The control group will be fed according to the standard nutrition policy (lipids from day 2 or 3 onwards). Different lipid emulsions will be compared.
P.O. Box 2060
J.B. Goudoever, van
Rotterdam 3000 CB
The Netherlands
+31 (0)10 4636363
j.vangoudoever@erasmusmc.nl
P.O. Box 2060
J.B. Goudoever, van
Rotterdam 3000 CB
The Netherlands
+31 (0)10 4636363
j.vangoudoever@erasmusmc.nl
Inclusion criteria
1. Inborn, Gestational weight less than 1500g
Exclusion criteria
1. Congenital anomalies
2. Metabolic disease
3. Endocrine, renal or hepatic disorder
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 | NL1385 |
| NTR-old | NTR1445 |
| Other | METC Erasmus MC : MEC-2008-186 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |