Dietary ModificationCOBO2NCT02566070
COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2
A study testing Continuous Gastric Feeding and Bolus Gastric Feeding in people with Dietary Modification, run by Akron Children's Hospital at 6 sites in United States.
Trial summary
This multi-center, prospective, randomized comparative effectiveness intervention study will evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated critically ill children for up through 12… Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Continuous Gastric Feeding and Bolus Gastric Feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2015to Dec 2018
- 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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all medical patients hospitalized in the Pediatric Intensive Care Unit (PICU)
- aged 1 month through 12 years of age
- mechanically ventilated within the first 24 hours of admission
- patients with an anticipated duration of mechanical ventilation greater than 48 hours
Who cannot join
- diagnosis of acute or chronic gastrointestinal pathology
- primary cardiac surgery or other surgical service patients
- enteral nutrition initiated greater than 48 hours post PICU admission, or
- enteral nutrition was initiated prior to admission to PICU
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Shands Children's Hospital
Gainesville, Florida, 32608
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73117
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
This multi-center, prospective, randomized comparative effectiveness intervention study will evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated critically ill children for up through 12 hours post achievement goal feeds or exclusion from feeding protocol, whichever comes first, to a maximum of 10 days.
Read the detailed description
A significant number of children (>30%) are malnourished upon admission to the Pediatric Intensive Care Unit (PICU). In addition, critically ill children are at risk to develop new or worsened malnutrition during their PICU stay. Adequate nutritional support of critically ill children reduces mortality and morbidities, such as hospital acquired health care infections. Inadequate nutrition during hospitalization results in poor healing, increased risk for hospital acquired conditions, and prolonged length of stay, all of which contribute to increased health care costs. Even previously healthy children experiencing critical illness are at high risk for malnourishment because of increased protein and/or caloric needs at a time when oral intake is inadequate to meet their metabolic needs. A gap in the literature exists regarding the effectiveness of 2 delivery modes for gastric enteral nutrition: continuous gastric (stomach) feeding (CGF), the steady infusion of liquid nutrition is delivered at an hourly volume via an infusion pump, and bolus gastric feeding (BGF), whereby nutrition is intermittently delivered over a prescribed period of time, followed by a period of rest.
Enteral nutrition (EN, or tube feeding) in the PICU is commonly given via continuous gastric feeding. However, feeding by bolus or intermittent methods better mimics normal body function and may minimize interruptions to feedings improving nutritional intake. This study proposes to address the gap in the literature regarding the best method to deliver EN to achieve prescribed nutritional goals and avoid feeding interruptions in the mechanically ventilated, critically ill pediatric population.
This multi-center, prospective, randomized, controlled study includes children 1-month to 12-years who are on a ventilator and have EN started within 48-hours of admission. Subjects are randomized to CGF or BGF. Feeding volume is advanced in a weight-based manner every 3-hours to target volume; caloric density is then increased to goal. Feeding intolerance measures are assessed every 3-hours. Study sites are assigned to follow one of two feeding intolerance criteria to better define the measures and thresholds necessary to halt and resume feeds for safety purposes. Incidence, duration and category of feeding interruptions are recorded. Statistical significance is defined as p < 0.05. The findings will be submitted for oral and poster presentation and manuscripts submitted for publication.
As the focus of nursing remains not on disease and cure, rather on healing and health, nutrition is embedded in this philosophy. Our vision of nursing is to put the patient in the best position to heal him or herself. Mitigating existing malnutrition and/or avoiding newly acquired nutritional deficits decreases the risk of mortality and hospital acquired adverse events in this population. This study seeks to optimize delivery of nutrition as therapy as imperative to optimize clinical and functional outcomes in the critically ill child.
- Conditions
- Dietary Modification
- Being tested
- Continuous Gastric Feeding, Bolus Gastric Feeding
- Keywords
- Enteral feeding, Continuous gastric feeding, Bolus gastric feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Gastric FeedingOther
Bolus Gastric FeedingOther
| Study group | Role | What they receive |
|---|---|---|
| Continuous Gastric Feeding (CGF) | Active comparator | CGF group will have total daily enteral nutrition requirement delivered at a constant rate via infusion over the entire 24 hour period. Receives: Other: Continuous Gastric Feeding |
| Bolus Gastric Feeding (BGF) | Experimental | BGF group will have total daily enteral nutrition requirement delivered in interval, finite volumes over the course of the 24 hour period. Receives: Other: Bolus Gastric Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol.
TTGF defined as time to attain goal feeds
Measured: 12 to 48 hours post enteral feeding
Secondary outcomes (6)
Feeding interruptions
measured by minutes feeds are withheld.
Measured: 12 to 48 hours post enteral feeding
Gastric residual volumes
measured in milliliters
Measured: 12 to 48 hours post enteral feeding
Rate of ventilator associated infections (VAI)
as reported by Infection Control Department.
Measured: 12 to 48 hours post enteral feeding
Oxygen Saturation Index
as calculated by [(FiO2 x Mean Airway Pressure)/SpO2]
Measured: 12 to 48 hours post enteral feeding
Emesis
as a binary yes/no event
Measured: 12 to 48 hours post enteral feeding
Abdominal girth
measured in centimeters
Measured: 12 to 48 hours post enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann-Marie Brown, PhD, CPNP, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566070
- Sponsor's protocol ID
- 150311
- Acronym
- COBO2
- Status last verified
- Jan 2020
- First submitted
- 24 Sep 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.
PubMed 22564954Mikhailov TA, Kuhn EM, Manzi J, Christensen M, Collins M, Brown AM, Dechert R, Scanlon MC, Wakeham MK, Goday PS. Early enteral nutrition is associated with lower mortality in critically ill children. JPEN J Parenter Enteral Nutr. 2014 May;38(4):459-66. doi: 10.1177/0148607113517903. Epub 2014 Jan 8.
PubMed 24403379Mehta NM, McAleer D, Hamilton S, Naples E, Leavitt K, Mitchell P, Duggan C. Challenges to optimal enteral nutrition in a multidisciplinary pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):38-45. doi: 10.1177/0148607109348065. Epub 2009 Nov 10.
PubMed 19903872Khorasani EN, Mansouri F. Effect of early enteral nutrition on morbidity and mortality in children with burns. Burns. 2010 Nov;36(7):1067-71. doi: 10.1016/j.burns.2009.12.005. Epub 2010 Apr 18.
PubMed 20403667Schindler CA, Mikhailov TA, Kuhn EM, Christopher J, Conway P, Ridling D, Scott AM, Simpson VS. Protecting fragile skin: nursing interventions to decrease development of pressure ulcers in pediatric intensive care. Am J Crit Care. 2011 Jan;20(1):26-34; quiz 35. doi: 10.4037/ajcc2011754.
PubMed 21196569Larsen BM, Goonewardene LA, Field CJ, Joffe AR, Van Aerde JE, Olstad DL, Clandinin MT. Low energy intakes are associated with adverse outcomes in infants after open heart surgery. JPEN J Parenter Enteral Nutr. 2013 Mar;37(2):254-60. doi: 10.1177/0148607112463075. Epub 2012 Oct 11.
PubMed 23064254Mehta NM, Compher C; A.S.P.E.N. Board of Directors. A.S.P.E.N. Clinical Guidelines: nutrition support of the critically ill child. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):260-76. doi: 10.1177/0148607109333114. No abstract available.
PubMed 19398612Brown A-M, Forbes ML, Vitale VS, Tirodker UH, Zeller R. Effects of a gastric feeding protocol on efficiency of enteral nutrition in critically ill infants and children. ICAN: Infant, Child, & Adolescent Nutrition. 2012;4(3):175-180.
Tume L, Carter B, Latten L. A UK and Irish survey of enteral nutrition practices in paediatric intensive care units. Br J Nutr. 2013 Apr 14;109(7):1304-22. doi: 10.1017/S0007114512003042. Epub 2012 Aug 1.
PubMed 22853808Mohr F, Steffen R. Physiology of gastrointestinal motility. In: Wyllie R, Hyams JS, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 4th ed. Philadelphia, PA: Elsevier/Saunders; 2011:39-49.
Chen YC, Chou SS, Lin LH, Wu LF. The effect of intermittent nasogastric feeding on preventing aspiration pneumonia in ventilated critically ill patients. J Nurs Res. 2006 Sep;14(3):167-80. doi: 10.1097/01.jnr.0000387575.66598.2a.
PubMed 16967399Lee JS, Auyeung TW. A comparison of two feeding methods in the alleviation of diarrhoea in older tube-fed patients: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):388-93. doi: 10.1093/ageing/32.4.388.
PubMed 12851181Lee JS, Kwok T, Chui PY, Ko FW, Lo WK, Kam WC, Mok HL, Lo R, Woo J. Can continuous pump feeding reduce the incidence of pneumonia in nasogastric tube-fed patients? A randomized controlled trial. Clin Nutr. 2010 Aug;29(4):453-8. doi: 10.1016/j.clnu.2009.10.003. Epub 2009 Nov 12.
PubMed 19910085Horn D, Chaboyer W. Gastric feeding in critically ill children: a randomized controlled trial. Am J Crit Care. 2003 Sep;12(5):461-8.
PubMed 14503430Hurt RT, McClave SA. Gastric residual volumes in critical illness: what do they really mean? Crit Care Clin. 2010 Jul;26(3):481-90, viii-ix. doi: 10.1016/j.ccc.2010.04.010.
PubMed 20643301
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COntinuous vs BOlus Nasogastric Feeding in Mechanically Ventilated Pediatric Patients 2
- ClinicalTrials.gov ID
- NCT02566070
- Acronym / sponsor ID
- COBO2 / 150311
- Conditions
- Dietary Modification
- Keywords
- Enteral feeding, Continuous gastric feeding, Bolus gastric feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 1 Oct 2015 (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.
This multi-center, prospective, randomized comparative effectiveness intervention study will evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated critically ill children for up through 12 hours post achievement goal feeds or exclusion from feeding protocol, whichever comes first, to a maximum of 10 days.
Detailed description
A significant number of children (>30%) are malnourished upon admission to the Pediatric Intensive Care Unit (PICU). In addition, critically ill children are at risk to develop new or worsened malnutrition during their PICU stay. Adequate nutritional support of critically ill children reduces mortality and morbidities, such as hospital acquired health care infections. Inadequate nutrition during hospitalization results in poor healing, increased risk for hospital acquired conditions, and prolonged length of stay, all of which contribute to increased health care costs. Even previously healthy children experiencing critical illness are at high risk for malnourishment because of increased protein and/or caloric needs at a time when oral intake is inadequate to meet their metabolic needs. A gap in the literature exists regarding the effectiveness of 2 delivery modes for gastric enteral nutrition: continuous gastric (stomach) feeding (CGF), the steady infusion of liquid nutrition is delivered at an hourly volume via an infusion pump, and bolus gastric feeding (BGF), whereby nutrition is intermittently delivered over a prescribed period of time, followed by a period of rest.
Enteral nutrition (EN, or tube feeding) in the PICU is commonly given via continuous gastric feeding. However, feeding by bolus or intermittent methods better mimics normal body function and may minimize interruptions to feedings improving nutritional intake. This study proposes to address the gap in the literature regarding the best method to deliver EN to achieve prescribed nutritional goals and avoid feeding interruptions in the mechanically ventilated, critically ill pediatric population.
This multi-center, prospective, randomized, controlled study includes children 1-month to 12-years who are on a ventilator and have EN started within 48-hours of admission. Subjects are randomized to CGF or BGF. Feeding volume is advanced in a weight-based manner every 3-hours to target volume; caloric density is then increased to goal. Feeding intolerance measures are assessed every 3-hours. Study sites are assigned to follow one of two feeding intolerance criteria to better define the measures and thresholds necessary to halt and resume feeds for safety purposes. Incidence, duration and category of feeding interruptions are recorded. Statistical significance is defined as p < 0.05. The findings will be submitted for oral and poster presentation and manuscripts submitted for publication.
As the focus of nursing remains not on disease and cure, rather on healing and health, nutrition is embedded in this philosophy. Our vision of nursing is to put the patient in the best position to heal him or herself. Mitigating existing malnutrition and/or avoiding newly acquired nutritional deficits decreases the risk of mortality and hospital acquired adverse events in this population. This study seeks to optimize delivery of nutrition as therapy as imperative to optimize clinical and functional outcomes in the critically ill child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Gastric Feeding (CGF) | Active comparator | Other: Continuous Gastric FeedingCGF group will have total daily enteral nutrition requirement delivered at a constant rate via infusion over the entire 24 hour period. |
| Bolus Gastric Feeding (BGF) | Experimental | Other: Bolus Gastric FeedingBGF group will have total daily enteral nutrition requirement delivered in interval, finite volumes over the course of the 24 hour period. |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- all medical patients hospitalized in the Pediatric Intensive Care Unit (PICU)
- aged 1 month through 12 years of age
- mechanically ventilated within the first 24 hours of admission
- patients with an anticipated duration of mechanical ventilation greater than 48 hours
Key exclusion criteria (4 listed)
- diagnosis of acute or chronic gastrointestinal pathology
- primary cardiac surgery or other surgical service patients
- enteral nutrition initiated greater than 48 hours post PICU admission, or
- enteral nutrition was initiated prior to admission to PICU
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 |
|---|---|---|
| Continuous Gastric Feeding | Other | Continuous Gastric Feeding (CGF) |
| Bolus Gastric Feeding | Other | Bolus Gastric Feeding (BGF) |
Primary outcome
Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol.
Time frame: 12 to 48 hours post enteral feeding
TTGF defined as time to attain goal feeds
6 secondary outcomes
Feeding interruptions
Time frame: 12 to 48 hours post enteral feeding
Gastric residual volumes
Time frame: 12 to 48 hours post enteral feeding
Rate of ventilator associated infections (VAI)
Time frame: 12 to 48 hours post enteral feeding
Oxygen Saturation Index
Time frame: 12 to 48 hours post enteral feeding
Emesis
Time frame: 12 to 48 hours post enteral feeding
Abdominal girth
Time frame: 12 to 48 hours post enteral feeding
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 18 Jan 2020.
- Background: PubMed 22564954Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.
- Background: PubMed 24403379Mikhailov TA, Kuhn EM, Manzi J, Christensen M, Collins M, Brown AM, Dechert R, Scanlon MC, Wakeham MK, Goday PS. Early enteral nutrition is associated with lower mortality in critically ill children. JPEN J Parenter Enteral Nutr. 2014 May;38(4):459-66. doi: 10.1177/0148607113517903. Epub 2014 Jan 8.
- Background: PubMed 19903872Mehta NM, McAleer D, Hamilton S, Naples E, Leavitt K, Mitchell P, Duggan C. Challenges to optimal enteral nutrition in a multidisciplinary pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):38-45. doi: 10.1177/0148607109348065. Epub 2009 Nov 10.
- Background: PubMed 20403667Khorasani EN, Mansouri F. Effect of early enteral nutrition on morbidity and mortality in children with burns. Burns. 2010 Nov;36(7):1067-71. doi: 10.1016/j.burns.2009.12.005. Epub 2010 Apr 18.
- Background: PubMed 21196569Schindler CA, Mikhailov TA, Kuhn EM, Christopher J, Conway P, Ridling D, Scott AM, Simpson VS. Protecting fragile skin: nursing interventions to decrease development of pressure ulcers in pediatric intensive care. Am J Crit Care. 2011 Jan;20(1):26-34; quiz 35. doi: 10.4037/ajcc2011754.
- Background: PubMed 23064254Larsen BM, Goonewardene LA, Field CJ, Joffe AR, Van Aerde JE, Olstad DL, Clandinin MT. Low energy intakes are associated with adverse outcomes in infants after open heart surgery. JPEN J Parenter Enteral Nutr. 2013 Mar;37(2):254-60. doi: 10.1177/0148607112463075. Epub 2012 Oct 11.
- Background: PubMed 19398612Mehta NM, Compher C; A.S.P.E.N. Board of Directors. A.S.P.E.N. Clinical Guidelines: nutrition support of the critically ill child. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):260-76. doi: 10.1177/0148607109333114. No abstract available.
- BackgroundBrown A-M, Forbes ML, Vitale VS, Tirodker UH, Zeller R. Effects of a gastric feeding protocol on efficiency of enteral nutrition in critically ill infants and children. ICAN: Infant, Child, & Adolescent Nutrition. 2012;4(3):175-180.
- Background: PubMed 22853808Tume L, Carter B, Latten L. A UK and Irish survey of enteral nutrition practices in paediatric intensive care units. Br J Nutr. 2013 Apr 14;109(7):1304-22. doi: 10.1017/S0007114512003042. Epub 2012 Aug 1.
- BackgroundMohr F, Steffen R. Physiology of gastrointestinal motility. In: Wyllie R, Hyams JS, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 4th ed. Philadelphia, PA: Elsevier/Saunders; 2011:39-49.
- Background: PubMed 16967399Chen YC, Chou SS, Lin LH, Wu LF. The effect of intermittent nasogastric feeding on preventing aspiration pneumonia in ventilated critically ill patients. J Nurs Res. 2006 Sep;14(3):167-80. doi: 10.1097/01.jnr.0000387575.66598.2a.
- Background: PubMed 12851181Lee JS, Auyeung TW. A comparison of two feeding methods in the alleviation of diarrhoea in older tube-fed patients: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):388-93. doi: 10.1093/ageing/32.4.388.
- 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.
Ann-Marie Brown, PhD, CPNP principal investigator
Akron Children's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Gastric Feeding and Bolus Gastric Feeding in people with Dietary Modification, run by Akron Children's Hospital at 6 sites 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 4 inclusion and 4 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Time to goal feeds (TTGF) is decreased in a bolus compared to continuous gastric feeding protocol. (time frame: 12 to 48 hours post enteral feeding). 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 NCT02566070, which also lists 25 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 18 Jan 2020.