Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants
Condition: Nutrition of Preterm Infants
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Early total enteral feeding (ETEF); Conventional enteral feeding (CEF)
Intervention type(s): Other; Other
Intervention description(s): In ETEF Group total required volume of fluid will be administered as oral feeds and no intravenous fluid will be given. Feeds will be started at 80 mL/kg and increased till 150ml/kg is attained.; CEF Group will receive some feed and some Intravenous fluids. Feeds will be slowly increased from 20 mL/kg on day 1 till full feeds 150ml/kg is attained on day 6 of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Early total enteral feeding (ETEF); Conventional enteral feeding (CEF); VLBW infants; NEC; Preterm infants