Routine Versus no Assessment of Gastric Residual Volumes in Very Low Birth Weight Infants Receiving Enteral Feeding Via Intermittent Feeding Tubes: A Randomized Controlled Trial.

Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants

Sponsors

Lead sponsor: AdventHealth

Source AdventHealth
Brief 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.

Overall Status Recruiting
Start Date May 3, 2019
Completion Date June 30, 2021
Primary Completion Date May 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Days to reach full enteral feeds 1 month after enrollment
Secondary Outcome
Measure Time Frame
Necrotizing enterocolitis Until hospital discharge, an average of 2-6 months
weight gain 4 weeks chronological age and 36 weeks corrected gestation
frequency of feeding interruptions Until full feeds are reached, usually between 2 weeks - 2 months
Enrollment 146
Condition
Intervention

Intervention type: Other

Intervention name: No Gastric residual volume monitoring

Description: Gastric residual volumes will not be monitored

Arm group label: NO GRV group

Eligibility

Criteria:

Inclusion Criteria:

1. Birth weight ≤1250g

2. Gestational age of < 33 weeks

3. Expected to receive feeds via gastric tubes

Exclusion Criteria:

1. Death expected within 72 hours of birth

2. Major chromosomal or congenital anomaly

3. Major GI anomaly such as gastroschisis, spontaneous perforation etc.

Gender: All

Minimum age: N/A

Maximum age: 1 Month

Healthy volunteers: No

Overall Contact

Last name: narendra Dereddy, MD

Phone: 4073032528

Email: [email protected]

Location
facility status contact AdventHealth Narendra Dereddy, MD 407-303-2528 [email protected]
Location Countries

United States

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: GRV group

Arm group type: No Intervention

Description: Gastric residuals will be checked prior to feeds

Arm group label: NO GRV group

Arm group type: Experimental

Description: Gastric residuals will not be checked prior to feeds

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Unblinded Single center Randomized controlled trial

Primary purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov