Evaluation of the effects of intravenous lipid and extra amino acid supplementation from birth onwards to very low birth weight infants on amino acid turnover and protein accretion. As secondary objectives the safety, energy expenditure and short-…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Nitrogen balance
Secondary outcome
Safety of the nutritional regimen: as reflected by normal blood chemistry, no
effect on hearing ability, no effect on chronic lung disease
Growth: measured in terms of body weight, protein accretion and protein
breakdown
Fatty acid profile in plasma and erythrocytes, plasma phytosterol profile
Energy expenditure
Short- and long-term outcome: days on mechanical ventilation, incidence of
bronchopulmonary dysplasia, incidence of infection, incidence of
intraventricular hemorrhage, incidence of necrotizing enterocolitis, normal
ALGO (screening for hearing loss), brain growth and development at 30 and 40
and/or 46 weeks gestational age and Bayley III scores (Mental Developmental
Index and Psychomotor Developmental Index) at 2 years of age (corrected age for
gestational age).
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 would like to compare two different fat emulsions (Intralipid
20% en SMOFlipid 20%).
Study objective
Evaluation of the effects of intravenous lipid and extra amino acid
supplementation from birth onwards to very low birth weight infants on amino
acid turnover and protein accretion. As secondary objectives the safety, energy
expenditure and short- and long-term outcome will be investigated.
Study design
Single-centred, randomized, prospective trial with open label
Intervention
The intervention group 1 will receive lipids from birth onwards. Intervention
group 2 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 3 onward). Half of the infants in the intervention
groups will receive Intralipid 20%, the other half SMOFlipid 20%.
Study burden and risks
Within the general study, two isotope substudies are performed. In substudy 1,
amino acid stable isotopes are infused via a venous catheter and blood samples
are withdrawn from an arterial catheter (both in situ for medical reasons). In
addition, expiratory air is collected. The child will hardly notice this. In
substudy 2, doubly labeled water (stable isotopes) will be infused and saliva
samples will be collected to evaluate energy expenditure. In addition, in 10
ventilated infants per group energy expenditure will be analyzed with indirect
calorimetry as well. In all included infants urine samples will be collected as
well on two separate days. Extended experience with the use of stable isotopes
in extreme premature infants has not shown side effects.
We hypothesize that patients who receive total parenteral nutrition from birth
onwards have an improved nutritional status and growth, and better clinical
outcome.
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Born within the Sophia Children's Hospital
Birth weight less than 1500g
Written informed consent
Exclusion criteria
Congenital anomalies
Metabolic disease
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 |
|---|---|
| CCMO | NL21277.078.08 |