None listed
Conditions
Brief summary
We aim to evaluate the effects of an “early” enteral feeding regimen, compared to one of “late” introduction of enteral feeds, in a group of very low birth weight infants. The timing of introduction and rate of progression of milk feeds is an area of clinical uncertainty with arguments in favour of both early and late introduction of enteral feeds. Early introduction may improve nutrition and growth, but may increase the risk of NEC. Conversely late introduction may be detrimental due to lack of stimulation of the gastrointestinal tract, resulting in villous atrophy and lack of hormone and enzyme production and may not reduce the incidence of NEC. Prolonged use of parenteral nutrition increases the risks of sepsis, cholestatic jaundice and vitamin and mineral deficiencies
Interventions
two different feeding'protocols: Infants with birth weight
between 750 and 1500 gr, consecutively admitted to the neonatal intensive care unit of the recruited Institutions were enrolled and randomly assigned to receive an early (Group A, <= 72h of life) or a late (Group B, >= 7
days of life) advancement of enteral feeding volume. A minimal enteral feeding (15 ml/kg/day of preterm formula) was started for all the infants within the first 24 hours of life. Daily advancement of enteral nutrition w
two different feeding'protocols: Infants with birth weight between 750 and 1500 gr, consecutively admitted to the neonatal intensive care unit of the recruited Institutions were enrolled and randomly assigned to receive an early (Group A, <= 72h of life) or a late (Group B, >= 7 days of life) advancement of enteral feeding volume. A minimal enteral feeding (15 ml/kg/day of preterm formula) was started for all the infants within the first 24 hours of life. Daily advancement of enteral nutrition was <= 20 ml/kg. Parenteral nutrition was administered until the infant was able to take 120 ml/kg of feeding enterally. this schedule will be applied until discharge the newborn
Sponsors
Buon Consiglio Fatebenefratelli Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 24 Hours
Healthy volunteers
No
Inclusion criteria
Infants with birth weight between 750 and 1500 gr, consecutively admitted to the neonatal intensive care unit of the recruited Institutions
Exclusion criteria
major congenital abnormality including known chromosomal abnormality, twin-twin transfusion, significant multi-organ failure prior to trial entry, already received any enteral feeding
Outcome results
None listed