Early Enteral Feeding AdvancementNCT01337622
Gastric Residuals in Preterm Infants
A study testing No check of gastric residuals for early enteral feeding advancement and Routine check of gastric residuals for early enteral feeding advancement in people with Early Enteral Feeding Advancement and Nutrition, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs the time to establish full gastric feeding in the early postnatal period. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Early Enteral Feeding Advancement, Nutrition, Preterm Infants
- What is being tested?
- No check of gastric residuals for early enteral feeding advancement and Routine check of gastric residuals for early enteral feeding advancement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Dec 2013
- 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 Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a birth weight ≥ 1500g and < 2000g
- Age ≤48 hours of life
- Informed, written parental consent
Who cannot join
- Antenatally recognized gastrointestinal malformation
- Major congenital anomaly
- Chromosomal anomaly
- NEC stage II
- Severe acidosis, asphyxia (pH <7.0)
- Severe growth restriction below 3rd percentile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Residuals in Preterm Infants (GRIP)
Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs the time to establish full gastric feeding in the early postnatal period.
- Being tested
- No check of gastric residuals for early enteral feeding advancement, Routine check of gastric residuals for early enteral feeding advancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No check of gastric residuals for early enteral feeding advancementProcedure or surgery
Discontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting.
Routine check of gastric residuals for early enteral feeding advancementProcedure or surgery
Discontinuation of gastric feeding and its advancement will be based on current practice of clinical examination of the abdomen and checking residual before every feed. Volume and color of gastric residual will be considered according to the current guideline.
| Study group | Role | What they receive |
|---|---|---|
| No routine check for gastric residuals | Experimental | Not described Receives: Procedure: No check of gastric residuals for early enteral feeding advancement |
| Routine check for gastric residuals | Active comparator | Not described Receives: Procedure: Routine check of gastric residuals for early enteral feeding advancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach full enteral feeding
Full enteral feeding is defned as an milk intake of equal or more than 120 ml/kg/d.
Measured: from inclusion (during first 48h of life) until 1 month
Secondary outcomes (1)
growth, tolerance, morbidity
Time to regain birth weight and maintain weight gain. Incidence of sepsis from birth until 48 hours after parenteral nutrition was administered.
Use of antibiotics. Incidence of feeding intolerance and necrotizing enterocolitis.
Measured: from inclusion (during first 48h of life) until one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
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 Early Enteral Feeding AdvancementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Fusch, McMaster Children's Hospital
- Investigators
- Sumesh Thomas, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337622
- Sponsor's protocol ID
- 201101GRIP
- Status last verified
- Mar 2015
- First submitted
- 15 Apr 2011
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Singh B, Rochow N, Chessell L, Wilson J, Cunningham K, Fusch C, Dutta S, Thomas S. Gastric Residual Volume in Feeding Advancement in Preterm Infants (GRIP Study): A Randomized Trial. J Pediatr. 2018 Sep;200:79-83.e1. doi: 10.1016/j.jpeds.2018.04.072. Epub 2018 Jun 1.
PubMed 29866595
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Residuals in Preterm Infants (GRIP)
- ClinicalTrials.gov ID
- NCT01337622
- Acronym / sponsor ID
- 201101GRIP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Apr 2011 (estimated)
- 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.
Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs the time to establish full gastric feeding in the early postnatal period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No routine check for gastric residuals | Experimental | Procedure: No check of gastric residuals for early enteral feeding advancement |
| Routine check for gastric residuals | Active comparator | Procedure: Routine check of gastric residuals for early enteral feeding advancement |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with a birth weight ≥ 1500g and < 2000g
- Age ≤48 hours of life
- Informed, written parental consent
Key exclusion criteria (6 listed)
- Antenatally recognized gastrointestinal malformation
- Major congenital anomaly
- Chromosomal anomaly
- NEC stage II
- Severe acidosis, asphyxia (pH <7.0)
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 check of gastric residuals for early enteral feeding advancementDiscontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting. | Procedure or surgery | No routine check for gastric residuals |
| Routine check of gastric residuals for early enteral feeding advancementDiscontinuation of gastric feeding and its advancement will be based on current practice of clinical examination of the abdomen and checking residual before every feed. Volume and color of gastric residual will be considered according to the current guideline. | Procedure or surgery | Routine check for gastric residuals |
Primary outcome
Time to reach full enteral feeding
Time frame: from inclusion (during first 48h of life) until 1 month
Full enteral feeding is defned as an milk intake of equal or more than 120 ml/kg/d.
1 secondary outcome
growth, tolerance, morbidity
Time frame: from inclusion (during first 48h of life) until one month
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 30 Mar 2015.
- Derived from this study: PubMed 29866595Singh B, Rochow N, Chessell L, Wilson J, Cunningham K, Fusch C, Dutta S, Thomas S. Gastric Residual Volume in Feeding Advancement in Preterm Infants (GRIP Study): A Randomized Trial. J Pediatr. 2018 Sep;200:79-83.e1. doi: 10.1016/j.jpeds.2018.04.072. Epub 2018 Jun 1.
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.
Sumesh Thomas, MD principal investigator
McMaster University
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 check of gastric residuals for early enteral feeding advancement and Routine check of gastric residuals for early enteral feeding advancement in people with Early Enteral Feeding Advancement and Nutrition, run by McMaster Children's Hospital at 1 site in Canada.
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 6 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 30 Mar 2015. 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 Canada. 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?
Time to reach full enteral feeding (time frame: from inclusion (during first 48h of life) until 1 month). 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 NCT01337622, 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 30 Mar 2015.