None listed
Conditions
Brief summary
We hypothesized that delaying the time needed to achieve macronutrients target of supplemental PN, beyond the critical window period (first week of life), even maintaining the same target value recommended, may reduce the occurrence of hyperglycemia in very low birth weight infants. Starting to these considerations, we designed a controlled clinical trial aiming to investigate the efficacy and safety of two PN strategies which were different for the time of target achievement ( Group 1: early target achievement of PN; 2) Group 2: delayed target achievement of PN).
Interventions
Intravenous administration of parenteral nutrition, administered by a neonatal physician, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. For newborns with birth weight less than 1000 g in Group 2: time of energy target dose achievement (100-110 kcal/kg/day), at 10-12 days of life; time of amino acids target dose achievement (3.5- 4.0 g/kg/day), at 5-7 days of life; time of dextrose target dose achievement (13.0 - 14.0 g/kg/day), at 10-12
Intravenous administration of parenteral nutrition, administered by a neonatal physician, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. For newborns with birth weight less than 1000 g in Group 2: time of energy target dose achievement (100-110 kcal/kg/day), at 10-12 days of life; time of amino acids target dose achievement (3.5- 4.0 g/kg/day), at 5-7 days of life; time of dextrose target dose achievement (13.0 - 14.0 g/kg/day), at 10-12 days of life; time of lipids target dose achievement (3.5-4.0 g/kg/day), at 5-7 days of life. For newborns with birth weight equal or greater than 1000 g in the Group 2: time of energy target dose achievement (90-100 kcal/kg/day), at 10-12 days of life; time of amino acids target dose achievement (3.5-4.0 g/kg/day), at 5-7 days of life; time of dextrose target dose achievement (13.0-14.0 g/kg/day), at 10-12 days of life; time of lipids target dose achievement (3.0-3.5 g/kg/day), at 5-7 days of life.
Sponsors
University of Rome "La Sapienza"
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 3 Days
Healthy volunteers
No
Inclusion criteria
Newborns with gestational age < 32 weeks or with birth weight <1500 g
Exclusion criteria
Neonates with major congenital malformations, inborn errors of metabolism, congenital infections, hospital discharge or death within 24 hours of life.
Outcome results
None listed