Infant and Young Child FeedingSAFESTNCT07136610
Standardized Application of Feeding Evaluations Using SMART Tool
A study testing SMART Tool in people with Infant and Young Child Feeding, run by Wake Forest University Health Sciences at 14 sites in United States.
Trial summary
Premature and medically complex infants have delayed development of oral feeding skills, leading to prolonged hospitalization, costs, and family stress. There is no "gold standard" infant feeding skill assessment tool for bedside clinicians. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infant and Young Child Feeding
- What is being tested?
- SMART Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Aug 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU
Who cannot join
- No oral feeding started by July 15, 2026
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Hope Reis, NPD, 804-464-7472, hope.reis@aah.org
Jenna Felix, RN
- Recruiting
Advocate Trinity Hospital
Chicago, Illinois, 60617
Karen Beagles, RN, 804-464-7472, karen.beagles@aah.org
Amber Barnes, RN
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Cynthia Manly, RN, 804-464-7472, cynthia.manly@aah.org
Julie Vannoord
- Recruiting
Aurora Medical Center Grafton
Grafton, Wisconsin, 53024
Julie Bulgrin, NPD, 804-464-7472, julie.bulgrin@aah.org
Julie Bulgrin, NPD
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Erica Huettl, NPD, 804-464-7472, erica.huettl@aah.org
Halli Schneiderwendt, RN
- Recruiting
Aurora Medical Center Kenosha
Kenosha, Wisconsin, 53142
Margaret Loehrke, NPD, 804-464-7472, margaret.loehrke@aah.org
Samantha Goodenough, RN
- Recruiting
Advocate Condell Medical Center
Libertyville, Illinois, 60048
Heidi Gutwoski, NPD, 804-464-7472, heidi.gutowski@aah.org
Heidi Gutwoski, NPD
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Kate Scythe, NPD, 804-464-7472, katelyn.scythe@aah.org
Shannon Brandel, SLP
- Recruiting
Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)
Oak Lawn, Illinois, 60453
Edythe Oliver, NPD, 804-464-7472, edythe.oliver@aah.org
Katlynn Alanza, RN
- Recruiting
Aurora Medical Center Oshkosh
Oshkosh, Wisconsin, 54904
Abbey Schonscheck, RN, 804-464-7472, abbey.schonscheck@aah.org
Wendy Roesler, RN
- Recruiting
Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)
Park Ridge, Illinois, 60068
Katie Kurnick, NPD, 804-464-7472, katie.kurncik@aah.org
Angela Lake, RN
- Recruiting
Aurora Medical Center - Sheboygan County
Sheboygan, Wisconsin, 53081
Michaele Schramm, RN, 804-464-7472, michaele.schramm@aah.org
Sara Jeanty, NPD
- Recruiting
Aurora Medical Center - Summit
Summit, Wisconsin, 53066
Dawn Hron, NPD, 804-464-7472, dawn.hron@aah.org
Dawn Hron, NPD
- Recruiting
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Shannon Schubel, NPD, 804-464-7472, shannon.schubel@aah.org
Carlye Butler, RN
About this study
Premature and medically complex infants have delayed development of oral feeding skills, leading to prolonged hospitalization, costs, and family stress. There is no "gold standard" infant feeding skill assessment tool for bedside clinicians. The research team developed a novel feeding skill assessment, the SMART Tool, to monitor infant feeding skill development in the neonatal intensive care unit. This study aims to determine whether this tool improves clinical outcomes, including reduced hospital days and enhanced safety and quality of infant feedings.
Read the detailed description
The current recommendation for preventing infant feeding problems is to provide cue-based feeding, which entails optimizing feeding based on infant cues, including behavioral and physiological signs of stress. These recommendations rely on appropriately recognizing infant feeding cues to inform care instead of applying time-based, volume-driven care irrespective of cues. Care providers vary widely in their subjective assessment of feeding skills, often because they lack standard education on feeding skill assessment and a "gold standard" tool to objectively measure infant oral feeding skill levels. This robust, step-wedge, cluster randomized trial was designed to evaluate the effect of implementing the SMART Tool in 14 different Neonatal Intensive Care Units (NICU) in the Advocate Health Midwest Region. The SMART Tool is a novel feeding assessment tool developed at Advocate Illinois Masonic Medical Center to objectively measure feeding readiness and skill. The psychometric properties were tested through a research study, and strong validity and reliability were established. The Advocate Health Midwest Region NICU standardization committee approved this tool as the sole feeding skill assessment tool to be used at each oral feed (eight times a day) for all NICU infants. Data on infants in the NICU will abstracted from the medical record at the time of discharge or death. The study will use PRISM and the REAIM Framework. The implementation framework consists of three parts that interact to influence outcomes (contextual factors, roll-out strategies, outcomes).
- Conditions
- Infant and Young Child Feeding
- Being tested
- SMART Tool
- Keywords
- premature infants, medically complex infants, infant feeding, feeding skills assessment, length of stay, infant developmental assessment, dysphagia of newborn, cluster randomized trial, length of NICU stay, breastfeeding
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART ToolBehavioural
Also called feeding skill assessment
The intervention in this implementation study involves (1) integrating the SMART Tool into electronic health records (EPIC), (2) educating all NICU staff (about 850 nurses, lactation consultants, speech-language pathologists, and physicians), and (3) Quality improvement to reinforce learning.
| Study group | Role | What they receive |
|---|---|---|
| SMART Tool | Experimental | Feeding skill assessment, the SMART Tool to monitor infant feeding skill development in the neonatal intensive care unit. Receives: Behavioral: SMART Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Days from birth to discharge
Measured: Month 6
Number of days to full oral feeds
Days from birth to full oral feeds
Measured: Month 6
Percent of Nasogastric tube days
Proportion of days with NG
Measured: Month 6
Secondary outcomes (1)
Home Tube Feeding
Proportion of infants discharged home with nasogastric tube or gastrosotomy tubes
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Aug 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Infant and Young Child FeedingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Mishra, MBBS, MD, Study chair, Advocate Illinois Masonic Medical CenterElizabeth Jensen, MPH, PhD, Principal investigator, Wake Forest University Health SciencesJoseph Chase, MPH, Principal investigator, Advocate Aurora Research InstituteAnne Albi, BS, MS, Principal investigator, Advocate Illinois Masonic Medical CenterCynthia Lira-Crame, BSN, MSN, Principal investigator, Advocate Illinois Masonic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136610
- Sponsor's protocol ID
- IRB00132685
- Acronym
- SAFEST
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
PubMed 16829207Hemming K, Taljaard M. Key considerations for designing, conducting and analysing a cluster randomized trial. Int J Epidemiol. 2023 Oct 5;52(5):1648-1658. doi: 10.1093/ije/dyad064.
PubMed 37203433Glasgow RE, Trinkley KE, Ford B, Rabin BA. The Application and Evolution of the Practical, Robust Implementation and Sustainability Model (PRISM): History and Innovations. Glob Implement Res Appl. 2024;4(4):404-420. doi: 10.1007/s43477-024-00134-6. Epub 2024 Aug 31.
PubMed 39568619Browne JV, Jaeger CB, Kenner C; Gravens Consensus Committee on Infant and Family Centered Developmental Care. Executive summary: standards, competencies, and recommended best practices for infant- and family-centered developmental care in the intensive care unit. J Perinatol. 2020 Sep;40(Suppl 1):5-10. doi: 10.1038/s41372-020-0767-1.
PubMed 32859958Russ SA, Hotez E, Berghaus M, Verbiest S, Hoover C, Schor EL, Halfon N. What Makes an Intervention a Life Course Intervention? Pediatrics. 2022 May 1;149(Suppl 5):e2021053509D. doi: 10.1542/peds.2021-053509D.
PubMed 35503318Sanders MR, Hall SL. Trauma-informed care in the newborn intensive care unit: promoting safety, security and connectedness. J Perinatol. 2018 Jan;38(1):3-10. doi: 10.1038/jp.2017.124. Epub 2017 Aug 17.
PubMed 28817114Samane S, Yadollah ZP, Marzieh H, Karimollah HT, Reza ZM, Afsaneh A, Als H. Cue-based feeding and short-term health outcomes of premature infants in newborn intensive care units: a non-randomized trial. BMC Pediatr. 2022 Jan 6;22(1):23. doi: 10.1186/s12887-021-03077-1.
PubMed 34991513Pineda R, Harris R, Foci F, Roussin J, Wallendorf M. Neonatal Eating Outcome Assessment: tool development and inter-rater reliability. Acta Paediatr. 2018 Mar;107(3):414-424. doi: 10.1111/apa.14128. Epub 2017 Dec 8.
PubMed 29059481Thoyre SM, Shaker CS, Pridham KF. The early feeding skills assessment for preterm infants. Neonatal Netw. 2005 May-Jun;24(3):7-16. doi: 10.1891/0730-0832.24.3.7.
PubMed 15960007Lubbe W. Clinicians guide for cue-based transition to oral feeding in preterm infants: An easy-to-use clinical guide. J Eval Clin Pract. 2018 Feb;24(1):80-88. doi: 10.1111/jep.12721. Epub 2017 Mar 2.
PubMed 28251754Crapnell TL, Rogers CE, Neil JJ, Inder TE, Woodward LJ, Pineda RG. Factors associated with feeding difficulties in the very preterm infant. Acta Paediatr. 2013 Dec;102(12):e539-45. doi: 10.1111/apa.12393. Epub 2013 Sep 30.
PubMed 23952198Adams-Chapman I, Bann CM, Vaucher YE, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition. J Pediatr. 2013 Sep;163(3):680-5.e1-3. doi: 10.1016/j.jpeds.2013.03.006. Epub 2013 Apr 10.
PubMed 23582139Goday PS, Huh SY, Silverman A, Lukens CT, Dodrill P, Cohen SS, Delaney AL, Feuling MB, Noel RJ, Gisel E, Kenzer A, Kessler DB, Kraus de Camargo O, Browne J, Phalen JA. Pediatric Feeding Disorder: Consensus Definition and Conceptual Framework. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):124-129. doi: 10.1097/MPG.0000000000002188.
PubMed 30358739Alshaikh B, Yusuf K, Dressler-Mund D, Mehrem AA, Augustine S, Bodani J, Yoon E, Shah P; Canadian Neonatal Network (CNN) and Canadian Preterm Birth Network (CPTBN) Investigators. Rates and Determinants of Home Nasogastric Tube Feeding in Infants Born Very Preterm. J Pediatr. 2022 Jul;246:26-33.e2. doi: 10.1016/j.jpeds.2022.03.012. Epub 2022 Mar 14.
PubMed 35301017Macias R, Peterson D, Korkis L, Edson R, Gall R. Prevalence and Impact of Feeding-Related Events on Hospital Stay in Preterm and Term Newborns. Adv Neonatal Care. 2023 Dec 1;23(6):541-546. doi: 10.1097/ANC.0000000000001115. Epub 2023 Oct 19.
PubMed 37862366
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Application of Feeding Evaluations Using SMART Tool
- ClinicalTrials.gov ID
- NCT07136610
- Acronym / sponsor ID
- SAFEST / IRB00132685
- Conditions
- Infant and Young Child Feeding
- Keywords
- premature infants, medically complex infants, infant feeding, feeding skills assessment, length of stay, infant developmental assessment, dysphagia of newborn, cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Aug 2025 (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.
Premature and medically complex infants have delayed development of oral feeding skills, leading to prolonged hospitalization, costs, and family stress. There is no "gold standard" infant feeding skill assessment tool for bedside clinicians. The research team developed a novel feeding skill assessment, the SMART Tool, to monitor infant feeding skill development in the neonatal intensive care unit. This study aims to determine whether this tool improves clinical outcomes, including reduced hospital days and enhanced safety and quality of infant feedings.
Detailed description
The current recommendation for preventing infant feeding problems is to provide cue-based feeding, which entails optimizing feeding based on infant cues, including behavioral and physiological signs of stress. These recommendations rely on appropriately recognizing infant feeding cues to inform care instead of applying time-based, volume-driven care irrespective of cues. Care providers vary widely in their subjective assessment of feeding skills, often because they lack standard education on feeding skill assessment and a "gold standard" tool to objectively measure infant oral feeding skill levels. This robust, step-wedge, cluster randomized trial was designed to evaluate the effect of implementing the SMART Tool in 14 different Neonatal Intensive Care Units (NICU) in the Advocate Health Midwest Region. The SMART Tool is a novel feeding assessment tool developed at Advocate Illinois Masonic Medical Center to objectively measure feeding readiness and skill. The psychometric properties were tested through a research study, and strong validity and reliability were established. The Advocate Health Midwest Region NICU standardization committee approved this tool as the sole feeding skill assessment tool to be used at each oral feed (eight times a day) for all NICU infants. Data on infants in the NICU will abstracted from the medical record at the time of discharge or death. The study will use PRISM and the REAIM Framework. The implementation framework consists of three parts that interact to influence outcomes (contextual factors, roll-out strategies, outcomes).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMART Tool | Experimental | Behavioral: SMART ToolFeeding skill assessment, the SMART Tool to monitor infant feeding skill development in the neonatal intensive care unit. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU
Key exclusion criteria (1 listed)
- No oral feeding started by July 15, 2026
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 |
|---|---|---|
| SMART ToolAlso: feeding skill assessmentThe intervention in this implementation study involves (1) integrating the SMART Tool into electronic health records (EPIC), (2) educating all NICU staff (about 850 nurses, lactation consultants, speech-language pathologists, and physicians), and (3) Quality improvement to reinforce learning. | Behavioural | SMART Tool |
Primary outcome
Length of hospital stay
Time frame: Month 6
Days from birth to discharge
Number of days to full oral feeds
Time frame: Month 6
Days from birth to full oral feeds
Percent of Nasogastric tube days
Time frame: Month 6
Proportion of days with NG
1 secondary outcome
Home Tube Feeding
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 16829207Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
- Background: PubMed 37203433Hemming K, Taljaard M. Key considerations for designing, conducting and analysing a cluster randomized trial. Int J Epidemiol. 2023 Oct 5;52(5):1648-1658. doi: 10.1093/ije/dyad064.
- Background: PubMed 39568619Glasgow RE, Trinkley KE, Ford B, Rabin BA. The Application and Evolution of the Practical, Robust Implementation and Sustainability Model (PRISM): History and Innovations. Glob Implement Res Appl. 2024;4(4):404-420. doi: 10.1007/s43477-024-00134-6. Epub 2024 Aug 31.
- Background: PubMed 32859958Browne JV, Jaeger CB, Kenner C; Gravens Consensus Committee on Infant and Family Centered Developmental Care. Executive summary: standards, competencies, and recommended best practices for infant- and family-centered developmental care in the intensive care unit. J Perinatol. 2020 Sep;40(Suppl 1):5-10. doi: 10.1038/s41372-020-0767-1.
- Background: PubMed 35503318Russ SA, Hotez E, Berghaus M, Verbiest S, Hoover C, Schor EL, Halfon N. What Makes an Intervention a Life Course Intervention? Pediatrics. 2022 May 1;149(Suppl 5):e2021053509D. doi: 10.1542/peds.2021-053509D.
- Background: PubMed 28817114Sanders MR, Hall SL. Trauma-informed care in the newborn intensive care unit: promoting safety, security and connectedness. J Perinatol. 2018 Jan;38(1):3-10. doi: 10.1038/jp.2017.124. Epub 2017 Aug 17.
- Background: PubMed 34991513Samane S, Yadollah ZP, Marzieh H, Karimollah HT, Reza ZM, Afsaneh A, Als H. Cue-based feeding and short-term health outcomes of premature infants in newborn intensive care units: a non-randomized trial. BMC Pediatr. 2022 Jan 6;22(1):23. doi: 10.1186/s12887-021-03077-1.
- Background: PubMed 29059481Pineda R, Harris R, Foci F, Roussin J, Wallendorf M. Neonatal Eating Outcome Assessment: tool development and inter-rater reliability. Acta Paediatr. 2018 Mar;107(3):414-424. doi: 10.1111/apa.14128. Epub 2017 Dec 8.
- Background: PubMed 15960007Thoyre SM, Shaker CS, Pridham KF. The early feeding skills assessment for preterm infants. Neonatal Netw. 2005 May-Jun;24(3):7-16. doi: 10.1891/0730-0832.24.3.7.
- Background: PubMed 28251754Lubbe W. Clinicians guide for cue-based transition to oral feeding in preterm infants: An easy-to-use clinical guide. J Eval Clin Pract. 2018 Feb;24(1):80-88. doi: 10.1111/jep.12721. Epub 2017 Mar 2.
- Background: PubMed 23952198Crapnell TL, Rogers CE, Neil JJ, Inder TE, Woodward LJ, Pineda RG. Factors associated with feeding difficulties in the very preterm infant. Acta Paediatr. 2013 Dec;102(12):e539-45. doi: 10.1111/apa.12393. Epub 2013 Sep 30.
- Background: PubMed 23582139Adams-Chapman I, Bann CM, Vaucher YE, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition. J Pediatr. 2013 Sep;163(3):680-5.e1-3. doi: 10.1016/j.jpeds.2013.03.006. Epub 2013 Apr 10.
- Psychometric Properties of the SMART Feeding ToolLink provided by the sponsor.
- Psychometric Properties of SMART Feeding Tool - AHMW SHARELink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Infant and Young Child Feeding
Active, not recruitingObservational study
Study on the Impact of Different Feeding Methods on Allergy Prevention and Digestive Absorption in Infants and Young Children
Infant Allergy, Infant Gut Health
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Recruiting
7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7D-1D Comparison)
Child Malnutrition
Recruiting
A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
Malnutrition in Children, Children Exposed to HIV
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.
Ravi Mishra, MBBS, MD study chair
Advocate Illinois Masonic Medical Center
Elizabeth Jensen, MPH, PhD principal investigator
Wake Forest University Health Sciences
Joseph Chase, MPH principal investigator
Advocate Aurora Research Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Tool in people with Infant and Young Child Feeding, run by Wake Forest University Health Sciences at 14 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ravi Mishra, MBBS,MD,FAAP (804.464.7472, ravi.mishra@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Month 6). The study lists 3 primary outcomes in all. 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 NCT07136610, which also lists 17 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 29 Jul 2026.