Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants
Condition: Gastric Residual Volume; Preterm Infant; Feeding Disorder Neonatal
MeSH terms: Premature Birth; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The practice of checking gastric residuals is not evidence based. The amount of gastric
      residual volume (GRV) does not correlate with either feeding intolerance or development of
      NEC. We hypothesize that not monitoring GRV in infants with birth weights < 1,250 g, and who
      are being fed intermittently by gastric tube, will result in earlier attainment of full
      feeding. This is an unblinded randomized controlled trial where GRV will not be checked
      routinely in the intervention group.
    

Detailed description: 
      The term "gastric residuals" in neonates refers to aspiration of gastric contents before each
      feeding in an infant receiving enteral feeding using an intermittent feeding tube. The
      presence of significant gastric residual volume (GRV) (Greater than 50% of the feeding
      volume) is a manifestation of delayed gastrointestinal maturation in a preterm neonate. The
      presence of GRV and its characteristics usually delays advancement of enteral feedings in
      premature infants because a large volume of undigested milk usually prompts the clinicians to
      hold the feeding.

      Advancement of early enteral nutrition is delayed or discontinued for >24 hours in nearly 75%
      of all extremely preterm infants. This is despite clinical evidence showing that early
      establishment of enteral nutrition is associated with reductions in the severity of critical
      illness, and long-lasting benefits on linear growth and neurodevelopmental outcomes.

      The magnitude and characteristics of GRV combined with specific findings based on abdominal
      examinations are usually considered by clinicians in decisions to continue with the scheduled
      enteral feeding plan. There are no studies to establish the normal volume of gastric
      residuals, its characteristics and whether routinely checking for them prior to each feed
      prevents necrotizing enterocolitis. A recent cohort study using retrospective controls showed
      that not monitoring GRV is associated with earlier attainment of full feeding in very low
      birth weight infants. Two small randomized studies conducted outside the United States and
      one study conducted in the United States showed no difference in outcomes when GRV are not
      checked routinely in preterm infants. These studies have several drawbacks and the practice
      of checking GRV continues.

      Study Objectives

      Primary Objective/Aim/Goal/Hypothesis

      The primary objective of this study is to demonstrate that not monitoring GRV in infants with
      birth weights < 1,250 g, and who are being fed intermittently by gastric tube, will result in
      earlier attainment of full feeding.

      Hypothesis:

      In preterm infants, changing the clinical practice from routine gastric residuals evaluation
      to no aspiration for gastric residuals will decrease the number of days to reach full enteral
      feeds.

      Secondary Objective/Aim/Goal/Hypothesis

      A secondary objective is to show that there will be no difference in the incidence of NEC
      (necrotizing enterocolitis) in the experimental vs the control group.

      Sample Size Determination

      Our NICU database shows that for infants <1,250 g the days to full feeding was 16.4 ±7.3
      days. To detect a relative decrease of 20% in the experimental group will require 73 infants
      in each group with an alpha of 0.05 and a power of 0.8.

      Statistical Analysis Plan

      Primary Objective Analysis

      The primary outcome analysis is the number of days to reach full feeding volume, defined as
      volume > 120 ml/kg/d. This time will be compared between the two groups using analysis of
      variance.

      Secondary Objective Analysis

      Secondary analysis will be focused the frequency of feeding interruptions, incidences of NEC
      between the two groups using analysis of variance.
    

Intervention name(s): No Gastric residual volume monitoring
Intervention type(s): Other
Intervention description(s): Gastric residual volumes will not be monitored
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Unblinded Single center Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: gastric residuals, feeding, very low birth weight infants