- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062851
Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32803
- AdventHealth
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Birth weight ≤1250g
- Gestational age of < 33 weeks
- Expected to receive feeds via gastric tubes
Exclusion Criteria:
- Death expected within 72 hours of birth
- Major chromosomal or congenital anomaly
- Major GI anomaly such as gastroschisis, spontaneous perforation etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: GRV group
Gastric residuals will be checked prior to feeds
|
|
Experimental: NO GRV group
Gastric residuals will not be checked prior to feeds
|
Gastric residual volumes will not be monitored
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days to reach full enteral feeds
Time Frame: 1 month after enrollment
|
Days to reach enteral feeding volume of 120ml/kg/day
|
1 month after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Necrotizing enterocolitis
Time Frame: Until hospital discharge, an average of 2-6 months
|
Stage 2 NEC and higher grade
|
Until hospital discharge, an average of 2-6 months
|
weight gain
Time Frame: 4 weeks chronological age and 36 weeks corrected gestation
|
Weight gain velocity in gm/kg/d
|
4 weeks chronological age and 36 weeks corrected gestation
|
frequency of feeding interruptions
Time Frame: Until full feeds are reached, usually between 2 weeks - 2 months
|
Number of timed feeds are withheld
|
Until full feeds are reached, usually between 2 weeks - 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Narendra Dereddy, MD, AdventHealth
Publications and helpful links
General Publications
- Li YF, Lin HC, Torrazza RM, Parker L, Talaga E, Neu J. Gastric residual evaluation in preterm neonates: a useful monitoring technique or a hindrance? Pediatr Neonatol. 2014 Oct;55(5):335-40. doi: 10.1016/j.pedneo.2014.02.008. Epub 2014 Aug 14.
- Torrazza RM, Parker LA, Li Y, Talaga E, Shuster J, Neu J. The value of routine evaluation of gastric residuals in very low birth weight infants. J Perinatol. 2015 Jan;35(1):57-60. doi: 10.1038/jp.2014.147. Epub 2014 Aug 28.
- Parker L, Torrazza RM, Li Y, Talaga E, Shuster J, Neu J. Aspiration and evaluation of gastric residuals in the neonatal intensive care unit: state of the science. J Perinat Neonatal Nurs. 2015 Jan-Mar;29(1):51-9; quiz E2. doi: 10.1097/JPN.0000000000000080.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1255832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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