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Nutritional Intervention for Preterm Infants-2


- candidate number3985
- NTR NumberNTR1445
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-sep-2008
- Secondary IDsMEC-2008-186 METC Erasmus MC
- Public TitleNutritional Intervention for Preterm Infants-2
- Scientific TitleNutritional Intervention for Preterm Infants-2
- ACRONYMNIPI-2
- hypothesisEarly lipid and extra amino acid administration is safe and effective and leads to improved short- and long-term outcome.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, Preterm infants, Feeding tolerance, Parenteral nutrition
- Inclusion criteria1. Inborn, Gestational weight less than 1500g
- Exclusion criteria1. Congenital anomalies
2. Metabolic disease
3. Endocrine, renal or hepatic disorder
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-okt-2008
- planned closingdate6-okt-2010
- Target number of participants240
- InterventionsIntervention 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.
- Primary outcomeNitrogen balance
- Secondary outcome1. 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
- TimepointsMost 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. MD. PhD. J.B. Goudoever, van
- CONTACT for SCIENTIFIC QUERIESProf. MD. PhD. J.B. Goudoever, van
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- PublicationsN/A
- Brief summaryAfter 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.
- Main changes (audit trail)
- RECORD15-sep-2008 - 29-sep-2008


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