None listed
Conditions
Brief summary
To assess the best energy intake for very low birth weight newborns, considering both possible benefits for growth and risk of metabolic complications, we designed a prospective study, comparing Cohort of newborns, which received Energy-Enhanced (Cohort A) vs. Standard (Cohort B) Parenteral Nutrition. The main outcome measure was the growth until 24 months of life. Extra-uterine growth retardation, complications associated with PN, survival, length of the hospital stay and morbidity at time point of 36 weeks of Post Menstrual Age were also measured.
Interventions
Intravenous administration of parenteral nutrition given by neonatal specialist, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. For newborns with a birth weight less than 1000 g in the Cohort B: Energy starting dose 45 kcal/kg/day and target dose 105 kcal/kg/day at 7 days of life; Proteins starting dose 2.0 g/kg/day and target dose 4.0 g/kg/day at 7 days of life; Dextrose starting dose 7.0 g/kg/day and target dose 14.0 at 7 days of life;
Intravenous administration of parenteral nutrition given by neonatal specialist, starting from the first day of life. Adherence to the intervention was monitored by clinical observation. For newborns with a birth weight less than 1000 g in the Cohort B: Energy starting dose 45 kcal/kg/day and target dose 105 kcal/kg/day at 7 days of life; Proteins starting dose 2.0 g/kg/day and target dose 4.0 g/kg/day at 7 days of life; Dextrose starting dose 7.0 g/kg/day and target dose 14.0 at 7 days of life; Lipids starting dose 1.0 g/kg/day and target dose 3.5 at 7 days of life. For newborns with a birth weight greater than or equal to 1000 g in the Cohort B: Energy starting dose 45 kcal/kg/day and target dose 100 kcal/kg/day at 7 days of life; Proteins starting dose 2.0 g/kg/day and target dose 3.5 g/kg/day at 7 days of life; Dextrose starting dose 7.0 g/kg/day and target dose 14.5 at 7 days of life; Lipids starting dose 1.0 g/kg/day and target dose 3.0 at 7 days of life.
Sponsors
Department of Maternal and Child Health Policlinico Umberto I, University La Sapienza, Rome, Italy
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 2 Years
Healthy volunteers
No
Inclusion criteria
Newborns with gestational age <32 weeks or with birth weight <1500 g,
Exclusion criteria
Infants with major congenital malformations, inborn errors of metabolism, congenital infections, hospital discharge or death within 72 hours of life.
Outcome results
None listed