An interventional study of No Gastric residual volume monitoring in Gastric Residual Volume, Preterm Infant and Feeding Disorder Neonatal, sponsored by AdventHealth. Completed at 1 site in United States. Open to participants aged 2 Hours to 1 Month. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by AdventHealth · Not applicable, Interventional, and Supportive care
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.
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.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 80 is close to the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →AdventHealth is the lead sponsor of 113 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Exclusion Criteria:
Gastric residuals will be checked prior to feeds
Gastric residuals will not be checked prior to feeds
Other: No Gastric residual volume monitoring
Gastric residual volumes will not be monitored
Days to reach full enteral feeds
Days to reach enteral feeding volume of 120ml/kg/day
Time frame: 1 month after enrollment
Necrotizing enterocolitis
Stage 2 NEC and higher grade
Time frame: Until hospital discharge, an average of 2-6 months
weight gain
Weight gain velocity in gm/kg/d
Time frame: 4 weeks chronological age and 36 weeks corrected gestation
frequency of feeding interruptions
Number of timed feeds are withheld
Time frame: Until full feeds are reached, usually between 2 weeks - 2 months
Plan to share: No
Ran from May 2019 to primary completion in Jul 2021, 26 months.
Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 26 months is close to that.
Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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