Nutrition of Preterm Infants Clinical Trial
Official title:
Comparison of Early Total Enteral Feeding (ETEF) Versus Conventional Enteral Feeding (CEF) in Stable Very Low Birth Weight (VLBW) Infants - A Randomized Controlled Trial
The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants. In current clinical practice, the introduction of oral feeds for VLBW infants is often preceded by a period of fasting or minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be associated with potential disadvantages and increased infectious and metabolic complications related to prolonged fasting and use of parenteral nutrition. The studies conducted till date have shown better outcomes and improved postnatal growth with early initiation and fast advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total oral feeds on day 1 of life. No such study has been conducted on early total oral feeding but observational work in our unit has shown it to be safe without any increased incidence of feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW infants all over the world, the investigators decided to assess the effect of early total enteral feeding in stable VLBW infants.
Preterm VLBW infants often have negligible intrauterine reserves of nutrition along with a
host of medical conditions postbirth including respiratory distress syndrome, hypoxia,
hypotension, acidosis, infection and surgery. These conditions increase the metabolic energy
requirements and nutrient needs of preterm babies. They require more specialised nutrition
because of their faster growth rates; to correct the growth faltering post birth and to
attain appropriate weight gain. Delayed postnatal growth due to inappropriate nutrition in
early period leads to long term cognitive impairment and decreased school performance.
Additional impediments to growth are high degree of biochemical and physiological immaturity
of gastro intestinal tract with an immature immune system.
In current clinical practice, the introduction of progressive enteral feeds for preterm VLBW
infants is often preceded by a period of enteral fasting or minimal enteral nutrition to
decrease the incidence of NEC. However, there may also be potential disadvantages associated
with delayed introduction of progressive enteral feeds. Gastrointestinal hormone secretion
and motility is stimulated by enteral milk and hence delayed enteral feeding could diminish
the functional adaptation of the gastrointestinal tract. In addition, 'starving' the gut may
be harmful increasing susceptibility to infection due to impaired barrier function by
intestinal epithelium. Parenteral nutrition (PN), though having an important role in early
stabilization by allowing early calorie intake and preventing catabolism, is associated with
significant risks of infectious and metabolic complications thereby increasing mortality and
morbidity, prolonging hospital stay, and adversely affecting growth and development. As per
recent literature reviews, enteral feeding has many advantages including appropriate intake
of most nutrients. It also promotes growth and development of the gut and reduces the risk
of infection. It is therefore important to establish enteral feeding as early as is safely
possible. It has been argued that the risk of NEC should not be considered in isolation of
these other potential clinical outcomes when determining feeding policies and practices for
VLBW infants. A systematically conducted, randomized controlled trial is necessary to prove
or refute the benefits of early total enteral feeding and nutrition. Hence the purpose of
this prospective randomized controlled trial is to compare the benefits of early total
enteral feeding over conventional enteral feeding in terms of attainment of full feeds,
incidence of sepsis & NEC and duration of hospital stay.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care