Gastric Residual VolumeNCT04062851
Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants
A study testing No Gastric residual volume monitoring in people with Gastric Residual Volume and Preterm Infant, run by AdventHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 hours to 1 month
- Conditions the study is for
- Gastric Residual Volume, Preterm Infant, Feeding Disorder Neonatal
- What is being tested?
- No Gastric residual volume monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 hours to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight ≤1250g
- Gestational age of < 33 weeks
- Expected to receive feeds via gastric tubes
Who cannot join
- Death expected within 72 hours of birth
- Major chromosomal or congenital anomaly
- Major GI anomaly such as gastroschisis, spontaneous perforation etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the 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.
- Being tested
- No Gastric residual volume monitoring
- Keywords
- gastric residuals, feeding, very low birth weight infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Gastric residual volume monitoringOther
Gastric residual volumes will not be monitored
| Study group | Role | What they receive |
|---|---|---|
| GRV group | No intervention | Gastric residuals will be checked prior to feeds |
| NO GRV group | Experimental | Gastric residuals will not be checked prior to feeds Receives: Other: No Gastric residual volume monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to reach full enteral feeds
Days to reach enteral feeding volume of 120ml/kg/day
Measured: 1 month after enrollment
Secondary outcomes (3)
Necrotizing enterocolitis
Stage 2 NEC and higher grade
Measured: Until hospital discharge, an average of 2-6 months
weight gain
Weight gain velocity in gm/kg/d
Measured: 4 weeks chronological age and 36 weeks corrected gestation
frequency of feeding interruptions
Number of timed feeds are withheld
Measured: Until full feeds are reached, usually between 2 weeks - 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start3 May 2019
- Primary completion26 Jul 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric Residual VolumeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded Single center Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narendra Dereddy, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062851
- Sponsor's protocol ID
- 1255832
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25129325Torrazza 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.
PubMed 25166623Parker 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.
PubMed 25633400
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04062851
- Acronym / sponsor ID
- 1255832
- Keywords
- gastric residuals, feeding, very low birth weight infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded Single center Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| GRV group | No intervention | –Gastric residuals will be checked prior to feeds |
| NO GRV group | Experimental | Other: No Gastric residual volume monitoringGastric residuals will not be checked prior to feeds |
Who may qualify
- Ages
- 2 hours to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight ≤1250g
- Gestational age of < 33 weeks
- Expected to receive feeds via gastric tubes
Key exclusion criteria (3 listed)
- Death expected within 72 hours of birth
- Major chromosomal or congenital anomaly
- Major GI anomaly such as gastroschisis, spontaneous perforation etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Gastric residual volume monitoringGastric residual volumes will not be monitored | Other | NO GRV group |
Primary outcome
Days to reach full enteral feeds
Time frame: 1 month after enrollment
Days to reach enteral feeding volume of 120ml/kg/day
3 secondary outcomes
Necrotizing enterocolitis
Time frame: Until hospital discharge, an average of 2-6 months
weight gain
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Results publication: PubMed 25129325Li 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.
- Results publication: PubMed 25166623Torrazza 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.
- Results publication: PubMed 25633400Parker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narendra Dereddy, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Gastric residual volume monitoring in people with Gastric Residual Volume and Preterm Infant, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to reach full enteral feeds (time frame: 1 month after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062851, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.