Respiratory InsufficiencyFeedNIVNCT01301352
Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation
A study testing Route of feeding (nasogastric vs. nasojejunal) in people with Respiratory Insufficiency and Pneumonia, Aspiration, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The investigators are studying whether it is safe and effective to provide enteral nutrition to critically ill children via the nasogastric route, as opposed to the nasojejunal route, while they are receiving noninvasive positive pressure ventilation. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Respiratory Insufficiency, Pneumonia, Aspiration, Nutrition Disorders
- What is being tested?
- Route of feeding (nasogastric vs. nasojejunal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Jun 2014
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age under 18 years old
- Acute respiratory failure as the indication for non-invasive ventilatory support
- Signed consent from parent or guardian
- Patients with a feeding tube in place who have not been fed in > 12 hours
Who cannot join
- Immediate postoperative cardiac surgery
- Chronic ventilatory support
- Admission diagnosis of aspiration pneumonia
- Known history of frequent aspiration (more than 2 previous admissions for this diagnosis)
- Contraindication to feeding tube placement (e.g. basal skull fracture)
- Imminent need for endotracheal intubation
Show all 15Show fewer
- Percutaneous gastric tube in place
- History of Nissen fundoplication
- Contraindication to study nutritional formulas (e.g. galactosemia)
- Allergy to metoclopramide
- No signed consent from parent or guardian
- Continuous Positive Airway Pressure (CPAP) with or without pressure support administered via an endotracheal tube
- Corrected gestational age under 38 weeks
- Patients with a feeding tube in place who have been fed within the last 12 hours
- Patients with a feeding tube in place in whom the PICU staff do not wish to change the position of the feeding tube (i.e. do not agree to randomize the patient's feeding tube position)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Gastric Feeding in Critically Ill Pediatric Patients Receiving Non-invasive Positive Pressure Ventilation: A Pilot Study
The investigators are studying whether it is safe and effective to provide enteral nutrition to critically ill children via the nasogastric route, as opposed to the nasojejunal route, while they are receiving noninvasive positive pressure ventilation.
Read the detailed description
It has been our experience that the placement of post-pyloric tubes can be difficult, and that these tubes frequently become obstructed and are difficult to replace, resulting in lost caloric intake for the patient. The population where this is most relevant is children receiving Noninvasive Positive Pressure Ventilation (NPPV). NPPV has become increasingly popular in the Pediatric Intensive Care Unit (PICU) population, due to its perception as a safe and effective alternative to mechanical ventilation via an endotracheal tube. Historically, NPPV has been used in children with chronic respiratory insufficiency, but its application for acute respiratory compromise is increasing. It has been shown to be effective in disease states associated with hypoventilation, and is now also being applied to respiratory problems leading to decreased oxygenation. Infants and children receiving noninvasive ventilation for respiratory failure, which is often infectious in origin, have significant caloric needs. However, it is our practice not to allow gastric feeding in these patients due to the fear of gastric distension and vomiting, which carries a risk of aspiration.
There is no data available on the question of efficacy and safety of gastric feeding in critically-ill children supported by noninvasive ventilation. Given the ease of (re)placement, and the potential nutritional benefit of earlier feeding provided by gastric feeding, it seems clinically important to question the bias against this route of enteral nutrition in noninvasively ventilated patients. The investigators therefore propose a pilot randomized trial of gastric versus post-pyloric feeds in patients on NPPV.
- Being tested
- Route of feeding (nasogastric vs. nasojejunal)
- Keywords
- Critical Care, Intubation, gastrointestinal, Child, Infant, Adolescent, Continuous positive airway pressure, Enteral Nutrition
- Medical subject headings
- Respiratory Insufficiency, Pneumonia, Aspiration, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Route of feeding (nasogastric vs. nasojejunal)Other
Safety and efficacy of feeding nasogastrically vs. nasojejunally while receiving noninvasive positive pressure ventilation
| Study group | Role | What they receive |
|---|---|---|
| Nasojejunal feeding (control) | No intervention | Not described |
| Nasogastric feeding (intervention) | Experimental | Not described Receives: Other: Route of feeding (nasogastric vs. nasojejunal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent goal enteral calories received while receiving NPPV
Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.
Measured: Daily up to 14 days
Secondary outcomes (3)
The time required to achieve goal calories while on NPPV
Measured: Hours (estimated up to 48 hours)
The length of stay in ICU and in hospital
Measured: Days (estimated up to 14 and 28 days, respectively)
Episodes of clinically important gastric aspiration
Measured: Episodes (number - up to 1 per subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allon Beck, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Pramod Puligandla, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301352
- Sponsor's protocol ID
- 10-192-PED
- Acronym
- FeedNIV
- Status last verified
- Jul 2014
- First submitted
- 22 Feb 2011
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2.
PubMed 19572118Antonelli M, Azoulay E, Bonten M, Chastre J, Citerio G, Conti G, De Backer D, Lemaire F, Gerlach H, Hedenstierna G, Joannidis M, Macrae D, Mancebo J, Maggiore SM, Mebazaa A, Preiser JC, Pugin J, Wernerman J, Zhang H. Year in review in Intensive Care Medicine 2009. Part III: mechanical ventilation, acute lung injury and respiratory distress syndrome, pediatrics, ethics, and miscellanea. Intensive Care Med. 2010 Apr;36(4):567-84. doi: 10.1007/s00134-010-1781-0. Epub 2010 Feb 23. No abstract available.
PubMed 20177660Barr J, Hecht M, Flavin KE, Khorana A, Gould MK. Outcomes in critically ill patients before and after the implementation of an evidence-based nutritional management protocol. Chest. 2004 Apr;125(4):1446-57. doi: 10.1378/chest.125.4.1446.
PubMed 15078758Binnekade JM, Tepaske R, Bruynzeel P, Mathus-Vliegen EM, de Hann RJ. Daily enteral feeding practice on the ICU: attainment of goals and interfering factors. Crit Care. 2005 Jun;9(3):R218-25. doi: 10.1186/cc3504. Epub 2005 Mar 22.
PubMed 15987393Braunschweig CL, Levy P, Sheean PM, Wang X. Enteral compared with parenteral nutrition: a meta-analysis. Am J Clin Nutr. 2001 Oct;74(4):534-42. doi: 10.1093/ajcn/74.4.534.
PubMed 11566654Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.
PubMed 19851094Casaer MP, Mesotten D, Schetz MR. Bench-to-bedside review: metabolism and nutrition. Crit Care. 2008;12(4):222. doi: 10.1186/cc6945. Epub 2008 Aug 19.
PubMed 18768091Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19.
PubMed 18712350Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
PubMed 15190137Gramlich L, Kichian K, Pinilla J, Rodych NJ, Dhaliwal R, Heyland DK. Does enteral nutrition compared to parenteral nutrition result in better outcomes in critically ill adult patients? A systematic review of the literature. Nutrition. 2004 Oct;20(10):843-8. doi: 10.1016/j.nut.2004.06.003.
PubMed 15474870Greenough A. Role of ventilation in RSV disease: CPAP, ventilation, HFO, ECMO. Paediatr Respir Rev. 2009 Jun;10 Suppl 1:26-8. doi: 10.1016/S1526-0542(09)70012-0.
PubMed 19651398Griffiths RD. Is parenteral nutrition really that risky in the intensive care unit? Curr Opin Clin Nutr Metab Care. 2004 Mar;7(2):175-81. doi: 10.1097/00075197-200403000-00012.
PubMed 15075709Griffiths RD, Bongers T. Nutrition support for patients in the intensive care unit. Postgrad Med J. 2005 Oct;81(960):629-36. doi: 10.1136/pgmj.2005.033399.
PubMed 16210458Gurgueira GL, Leite HP, Taddei JA, de Carvalho WB. Outcomes in a pediatric intensive care unit before and after the implementation of a nutrition support team. JPEN J Parenter Enteral Nutr. 2005 May-Jun;29(3):176-85. doi: 10.1177/0148607105029003176.
PubMed 15837777Hadfield RJ, Sinclair DG, Houldsworth PE, Evans TW. Effects of enteral and parenteral nutrition on gut mucosal permeability in the critically ill. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 1):1545-8. doi: 10.1164/ajrccm.152.5.7582291.
PubMed 7582291
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Gastric Feeding in Critically Ill Pediatric Patients Receiving Non-invasive Positive Pressure Ventilation: A Pilot Study
- ClinicalTrials.gov ID
- NCT01301352
- Acronym / sponsor ID
- FeedNIV / 10-192-PED
- Keywords
- Critical Care, Intubation, gastrointestinal, Child, Infant, Adolescent, Continuous positive airway pressure, Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Feb 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.
The investigators are studying whether it is safe and effective to provide enteral nutrition to critically ill children via the nasogastric route, as opposed to the nasojejunal route, while they are receiving noninvasive positive pressure ventilation.
Detailed description
It has been our experience that the placement of post-pyloric tubes can be difficult, and that these tubes frequently become obstructed and are difficult to replace, resulting in lost caloric intake for the patient. The population where this is most relevant is children receiving Noninvasive Positive Pressure Ventilation (NPPV). NPPV has become increasingly popular in the Pediatric Intensive Care Unit (PICU) population, due to its perception as a safe and effective alternative to mechanical ventilation via an endotracheal tube. Historically, NPPV has been used in children with chronic respiratory insufficiency, but its application for acute respiratory compromise is increasing. It has been shown to be effective in disease states associated with hypoventilation, and is now also being applied to respiratory problems leading to decreased oxygenation. Infants and children receiving noninvasive ventilation for respiratory failure, which is often infectious in origin, have significant caloric needs. However, it is our practice not to allow gastric feeding in these patients due to the fear of gastric distension and vomiting, which carries a risk of aspiration.
There is no data available on the question of efficacy and safety of gastric feeding in critically-ill children supported by noninvasive ventilation. Given the ease of (re)placement, and the potential nutritional benefit of earlier feeding provided by gastric feeding, it seems clinically important to question the bias against this route of enteral nutrition in noninvasively ventilated patients. The investigators therefore propose a pilot randomized trial of gastric versus post-pyloric feeds in patients on NPPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasojejunal feeding (control) | No intervention | – |
| Nasogastric feeding (intervention) | Experimental | Other: Route of feeding (nasogastric vs. nasojejunal) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age under 18 years old
- Acute respiratory failure as the indication for non-invasive ventilatory support
- Signed consent from parent or guardian
- Patients with a feeding tube in place who have not been fed in > 12 hours
Key exclusion criteria (15 listed)
- Immediate postoperative cardiac surgery
- Chronic ventilatory support
- Admission diagnosis of aspiration pneumonia
- Known history of frequent aspiration (more than 2 previous admissions for this diagnosis)
- Contraindication to feeding tube placement (e.g. basal skull fracture)
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 |
|---|---|---|
| Route of feeding (nasogastric vs. nasojejunal)Safety and efficacy of feeding nasogastrically vs. nasojejunally while receiving noninvasive positive pressure ventilation | Other | Nasogastric feeding (intervention) |
Primary outcome
The percent goal enteral calories received while receiving NPPV
Time frame: Daily up to 14 days
Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.
3 secondary outcomes
The time required to achieve goal calories while on NPPV
Time frame: Hours (estimated up to 48 hours)
The length of stay in ICU and in hospital
Time frame: Days (estimated up to 14 and 28 days, respectively)
Episodes of clinically important gastric aspiration
Time frame: Episodes (number - up to 1 per subject)
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 16 Jul 2014.
- Background: PubMed 19572118Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2.
- Background: PubMed 20177660Antonelli M, Azoulay E, Bonten M, Chastre J, Citerio G, Conti G, De Backer D, Lemaire F, Gerlach H, Hedenstierna G, Joannidis M, Macrae D, Mancebo J, Maggiore SM, Mebazaa A, Preiser JC, Pugin J, Wernerman J, Zhang H. Year in review in Intensive Care Medicine 2009. Part III: mechanical ventilation, acute lung injury and respiratory distress syndrome, pediatrics, ethics, and miscellanea. Intensive Care Med. 2010 Apr;36(4):567-84. doi: 10.1007/s00134-010-1781-0. Epub 2010 Feb 23. No abstract available.
- Background: PubMed 15078758Barr J, Hecht M, Flavin KE, Khorana A, Gould MK. Outcomes in critically ill patients before and after the implementation of an evidence-based nutritional management protocol. Chest. 2004 Apr;125(4):1446-57. doi: 10.1378/chest.125.4.1446.
- Background: PubMed 15987393Binnekade JM, Tepaske R, Bruynzeel P, Mathus-Vliegen EM, de Hann RJ. Daily enteral feeding practice on the ICU: attainment of goals and interfering factors. Crit Care. 2005 Jun;9(3):R218-25. doi: 10.1186/cc3504. Epub 2005 Mar 22.
- Background: PubMed 11566654Braunschweig CL, Levy P, Sheean PM, Wang X. Enteral compared with parenteral nutrition: a meta-analysis. Am J Clin Nutr. 2001 Oct;74(4):534-42. doi: 10.1093/ajcn/74.4.534.
- Background: PubMed 19851094Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.
- Background: PubMed 18768091Casaer MP, Mesotten D, Schetz MR. Bench-to-bedside review: metabolism and nutrition. Crit Care. 2008;12(4):222. doi: 10.1186/cc6945. Epub 2008 Aug 19.
- Background: PubMed 18712350Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19.
- Background: PubMed 15190137Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
- Background: PubMed 15474870Gramlich L, Kichian K, Pinilla J, Rodych NJ, Dhaliwal R, Heyland DK. Does enteral nutrition compared to parenteral nutrition result in better outcomes in critically ill adult patients? A systematic review of the literature. Nutrition. 2004 Oct;20(10):843-8. doi: 10.1016/j.nut.2004.06.003.
- Background: PubMed 19651398Greenough A. Role of ventilation in RSV disease: CPAP, ventilation, HFO, ECMO. Paediatr Respir Rev. 2009 Jun;10 Suppl 1:26-8. doi: 10.1016/S1526-0542(09)70012-0.
- Background: PubMed 15075709Griffiths RD. Is parenteral nutrition really that risky in the intensive care unit? Curr Opin Clin Nutr Metab Care. 2004 Mar;7(2):175-81. doi: 10.1097/00075197-200403000-00012.
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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.
Pramod Puligandla, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Route of feeding (nasogastric vs. nasojejunal) in people with Respiratory Insufficiency and Pneumonia, Aspiration, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 4 inclusion and 15 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 16 Jul 2014. 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?
The percent goal enteral calories received while receiving NPPV (time frame: Daily up to 14 days). 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 NCT01301352, which also lists 39 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 16 Jul 2014.