Gastric Residuals AssessmentGRASSNCT03111329
Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?
A study testing No aspiration of gastric residuals in people with Gastric Residuals Assessment and Prematurity, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 2 sites in 2 countries.
Trial summary
The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc. Read more about this study
- Who is it for?
- Ages 26 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Gastric Residuals Assessment, Prematurity, Sepsis Newborn
- What is being tested?
- No aspiration of gastric residuals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Oct 2017to 30 Jul 2021
- 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 26 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm neonate, born between 26+0 and 30+0 weeks of gestation
- Birth weight below 1500g
- Parental informed consent obtained
Who cannot join
- Intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender)
- Life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l
- Circulatory instability requiring treatment with inotropes
- Highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to NICU)
- Known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Randomized and Controlled Trial Comparing the Role of no Gastric Residual ASSessment and Standard Gastric Residual Measurement for the Achievement of Full Enteral Feeding in Preterm Infants
The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.
Read the detailed description
In general, regular assessment of gastric residuals and its´ evaluation prior to every feeding is considered standard practice for preterm neonates in neonatal intensive care units. It is believed useful to confirm correct placement of the orogastric or nasogastric tube and thought of as necessary to aid the decision of enteral feeding advancement by informing about possible remains of contents from previous feeding. Furthermore, evaluation of gastric residuals is routinely performed in order to assess for feeding intolerance and used as a possible indicator of risk for development of necrotizing enterocolitis.
However there is conflicting evidence to support the approach of routine gastric residuals assessment and it seems unclear whether it confers any clinical benefit. Withholding of enteral feeding or cessation of advancement in the amounts given due to misinterpretation of routine gastric aspirates may have a negative impact on the preterm neonate. This can potentially involve prolonged indwelling of venous catheters, higher risk of infection and growth restriction with potentially worse developmental outcome in particular for very low birth weight infants.
This randomized controlled clinical study aims to compare a control group with regular assessment and evaluation of gastric residuals and an intervention group with no routine assessment of residuals prior to feeding advancement, for the time taken to reach full enteral feeding and for occurrence of any observed complications including necrotizing enterocolitis.
- Conditions
- Gastric Residuals Assessment, Prematurity, Sepsis Newborn, Necrotizing Enterocolitis of Newborn
- Being tested
- No aspiration of gastric residuals
- Keywords
- Gastric residuals assessment, Prematurity, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Nutrition of newborn, feeding tolerance of newborn
- Medical subject headings
- Premature Birth, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No aspiration of gastric residualsOther
No assessment of gastric residuals will be performed prior to administering 3-hourly feeds with increasing amounts of the feeds given as per a predefined plan
| Study group | Role | What they receive |
|---|---|---|
| GRASS - Intervention group | Experimental | The intervention group (GRASS) will receive 3 hourly feeds, with no gastric residuals being aspirated. Solely opening of the nasogastric tube once every 6 hours to relieve possible backflow of gastric content will be allowed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours.
Intervention = NO aspiration of gastric residuals Receives: Other: No aspiration of gastric residuals |
| Standard Approach group | No intervention | Standard Approach group serving as control group will be treated as per standard approach - participants will be fed 3 hourly and gastric residuals checked via nasogastric tube prior to each feed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)
Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day
Measured: 5 days after delivery for yes or no answer to whether full enteral feeding has been achieved, thereafter daily for the first three weeks until full enteral feeding has been reached
Secondary outcomes (11)
Withholding of enteral feeding
The need to withhold enteral feeds due to clinical situation as per clinical judgement of the clinician in charge
Measured: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Total duration of parenteral infusion
The length of time (in hours) that parenteral infusion is needed
Measured: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Total duration of indwelling central venous catheter
The length of time (in hours) that an indwelling central venous catheter is needed
Measured: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Hypoglycaemia
Any episodes of hypoglycaemia (value less than 2,5 mmol/l) after attainment of full enteral feeding
Measured: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Late onset sepsis
The incidence of late onset sepsis
Measured: Duration of hospitalization, an average of 8-15 weeks
Necrotizing enterocolitis
The incidence of necrotizing enterocolitis
Measured: Duration of hospitalization, an average of 8-15 weeks
Spontaneous intestinal perforation
The incidence of spontaneous intestinal perforation
Measured: Duration of hospitalization, an average of 8-15 weeks
Bronchopulmonary dysplasia
Incidence of bronchopulmonary dysplasia
Measured: At timepoint of reached 36 gestational weeks of the neonate
Intraventricular and periventricular haemorrhage
The incidence of intraventricular and periventricular haemorrhage (stage I-IV)
Measured: Duration of hospitalization, an average of 8-15 weeks
Retinopathy of prematurity
Incidence of retinopathy of prematurity (stage I-V)
Measured: Duration of hospitalization, an average of 8-15 weeks
Neurodevelopment
Assessment of neurodevelopmental outcome
Measured: Follow up at 24 months of corrected age of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start6 Oct 2017
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Residuals AssessmentStudies 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
- Randomization into 2 groups (interventional and control) with crossover rescue strategy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Coombe Women and Infants University Hospital
- Responsible party
- Sponsor
- Investigators
- Zbynek Stranak, MD, Study chair, Institute for the Care of Mother and Child in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111329
- Sponsor's protocol ID
- GRASS-1
- Acronym
- GRASS
- Status last verified
- May 2024
- First submitted
- 23 Mar 2017
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available on request after publication of study results
Publications
Branagan A, Murphy C, O'Sullivan A, Bodnarova I, Feyereislova S, Berka I, Miletin J, Stranak Z. Influence of gastric residual assessment in preterm neonates on time to achieve enteral feeding (the GRASS trial)-Multi-centre, assessor-blinded randomised clinical trial. Eur J Pediatr. 2024 May;183(5):2325-2332. doi: 10.1007/s00431-024-05483-w. Epub 2024 Mar 1.
PubMed 38427039
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized and Controlled Trial Comparing the Role of no Gastric Residual ASSessment and Standard Gastric Residual Measurement for the Achievement of Full Enteral Feeding in Preterm Infants
- ClinicalTrials.gov ID
- NCT03111329
- Acronym / sponsor ID
- GRASS / GRASS-1
- Conditions
- Gastric Residuals Assessment, Prematurity, Sepsis Newborn, Necrotizing Enterocolitis of Newborn
- Keywords
- Gastric residuals assessment, Prematurity, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Nutrition of newborn, feeding tolerance of newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Institute for the Care of Mother and Child, Prague, Czech RepublicUniversity, hospital or other
- Collaborators
- Coombe Women and Infants University Hospital
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 12 Apr 2017 (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 study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.
Detailed description
In general, regular assessment of gastric residuals and its´ evaluation prior to every feeding is considered standard practice for preterm neonates in neonatal intensive care units. It is believed useful to confirm correct placement of the orogastric or nasogastric tube and thought of as necessary to aid the decision of enteral feeding advancement by informing about possible remains of contents from previous feeding. Furthermore, evaluation of gastric residuals is routinely performed in order to assess for feeding intolerance and used as a possible indicator of risk for development of necrotizing enterocolitis.
However there is conflicting evidence to support the approach of routine gastric residuals assessment and it seems unclear whether it confers any clinical benefit. Withholding of enteral feeding or cessation of advancement in the amounts given due to misinterpretation of routine gastric aspirates may have a negative impact on the preterm neonate. This can potentially involve prolonged indwelling of venous catheters, higher risk of infection and growth restriction with potentially worse developmental outcome in particular for very low birth weight infants.
This randomized controlled clinical study aims to compare a control group with regular assessment and evaluation of gastric residuals and an intervention group with no routine assessment of residuals prior to feeding advancement, for the time taken to reach full enteral feeding and for occurrence of any observed complications including necrotizing enterocolitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization into 2 groups (interventional and control) with crossover rescue strategy.
| Arm | Type | Receives |
|---|---|---|
| GRASS - Intervention group | Experimental | Other: No aspiration of gastric residualsThe intervention group (GRASS) will receive 3 hourly feeds, with no gastric residuals being aspirated. Solely opening of the nasogastric tube once every 6 hours to relieve possible backflow of gastric content will be allowed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours. Intervention = NO aspiration of gastric residuals |
| Standard Approach group | No intervention | –Standard Approach group serving as control group will be treated as per standard approach - participants will be fed 3 hourly and gastric residuals checked via nasogastric tube prior to each feed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours. |
Who may qualify
- Ages
- 26 to 30 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm neonate, born between 26+0 and 30+0 weeks of gestation
- Birth weight below 1500g
- Parental informed consent obtained
Key exclusion criteria (5 listed)
- Intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender)
- Life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l
- Circulatory instability requiring treatment with inotropes
- Highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to NICU)
- Known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations
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 aspiration of gastric residualsNo assessment of gastric residuals will be performed prior to administering 3-hourly feeds with increasing amounts of the feeds given as per a predefined plan | Other | GRASS - Intervention group |
Primary outcome
Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)
Time frame: 5 days after delivery for yes or no answer to whether full enteral feeding has been achieved, thereafter daily for the first three weeks until full enteral feeding has been reached
Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day
11 secondary outcomes
Withholding of enteral feeding
Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Total duration of parenteral infusion
Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Total duration of indwelling central venous catheter
Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Hypoglycaemia
Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Late onset sepsis
Time frame: Duration of hospitalization, an average of 8-15 weeks
Necrotizing enterocolitis
Time frame: Duration of hospitalization, an average of 8-15 weeks
Spontaneous intestinal perforation
Time frame: Duration of hospitalization, an average of 8-15 weeks
Bronchopulmonary dysplasia
Time frame: At timepoint of reached 36 gestational weeks of the neonate
Intraventricular and periventricular haemorrhage
Time frame: Duration of hospitalization, an average of 8-15 weeks
Retinopathy of prematurity
Time frame: Duration of hospitalization, an average of 8-15 weeks
Neurodevelopment
Time frame: Follow up at 24 months of corrected age of the child
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 10 May 2024.
- Derived from this study: PubMed 38427039Branagan A, Murphy C, O'Sullivan A, Bodnarova I, Feyereislova S, Berka I, Miletin J, Stranak Z. Influence of gastric residual assessment in preterm neonates on time to achieve enteral feeding (the GRASS trial)-Multi-centre, assessor-blinded randomised clinical trial. Eur J Pediatr. 2024 May;183(5):2325-2332. doi: 10.1007/s00431-024-05483-w. Epub 2024 Mar 1.
- Individual participant dataSharing planned: Yes. Available on request after publication of study results
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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.
Zbynek Stranak, MD study chair
Institute for the Care of Mother and Child in Prague
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No aspiration of gastric residuals in people with Gastric Residuals Assessment and Prematurity, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 2 sites in 2 countries.
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 5 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Ireland. 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?
Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day) (time frame: 5 days after delivery for yes or no answer to whether full enteral feeding has been achieved, thereafter daily for the first three weeks until full enteral feeding has been reached). 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 NCT03111329, which also lists 1 linked publication.
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 10 May 2024.