RecruitingACTRN12611000419965

Early Versus Late Progression of Enteral Feeding in Very Low Birth Weight (VLBW) Infants. A Randomized, Controlled, Multicenter Trial

Sponsor

Buon Consiglio Fatebenefratelli Hospital

Enrollment

120 participants

Start Date

Jun 1, 2010

Study Type

Interventional

Conditions

Nutrition of preterm infants

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

Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 24 Hourss

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to feeding very premature babies: starting milk feeds early (within the first 24 hours) versus starting later. Very small babies (under 1,500 grams) need careful feeding decisions because starting too early might increase the risk of a serious bowel condition (called NEC), but starting too late may also cause harm. This multicenter trial aims to find the safest and most beneficial approach. You may be eligible if: - Your baby was born weighing between 750 and 1,500 grams - Your baby was just admitted to the neonatal intensive care unit You may NOT be eligible if: - Your baby has a major birth defect or chromosomal abnormality - Your baby has twin-to-twin transfusion syndrome - Your baby has significant multi-organ failure - Your baby has already received any milk feeds before the trial Talk to your doctor about whether this trial might be right for you.

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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

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

Locations(1)

Italy

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ACTRN12611000419965