Purpose Minimizing Radiation-Induced-Lymphocyte-Kill (RILK), a key immune-suppressive effect of Radiation Therapy (RT) to augment tumor-specific immunity is timely and important. We assessed RT dose sparing to blood/immune-rich organs beyond Radiation-Therapy-Oncology-Group (RTOG) criteria, and its effect on RILK, and adverse events. Methods We conducted a single-institution phase-II randomized trial enrolling 51 early-stage NSCLC patients (IA–IB/IIA), to be treated with SBRT to evaluate the effect of dose reduction to immune rich organs on RILK, focusing on lymphocytes as primary immune cells. Participants were randomized to optimized-SBRT (reducing dose to blood, bone-marrow, lymph-nodes) or standard-SBRT, both following RTOG 0813/0915 guidelines. Peripheral blood was collected at baseline, same day, 4-weeks and 6-months post-treatment. Results Average percentage reductions in integral-dose, V5, and V10 to heart, lymph-nodes, and thoracic-vertebrae in the optimized-arm vs. standard-arm were 21%-68%(p=0.04 – 0.36), 37%-68%(p<0.001-0.01), and 57%-92%(p<0.001-0.002), respectively. Absolute Lymphocyte Counts (ALC) changes from baseline at immediate, 4-week, and 6-month post-SBRT were: optimized: -16%, -22%, -16%; standard: -31%, -34%, -26%; overall improvement: 13.4% (95% CI, 2.8-24.0; p=0.01) with optimized-treatment. Central tumors had the largest improvement: optimized: -8%, -18%, -14%; standard: -39%, -43%, -47%; overall improvement: 29.5% (95% CI, 10.1-48.9; p=0.004). Post SBRT grade 3 or higher lymphopenia occurred in 15.4% of standard arm patients but was absent in the optimized arm (risk difference -15.4%, 95% CI: -29.2%, -1.5%; p = 0.04). Standard-arm: 11.5% (only peripheral with PTV <20 cc group) and optimized-arm: 32% (all sub-groups) patients had a post-SBRT ALC increase. Dose to immune-rich organs (heart, great vessels, thoracic spine, and lymph nodes) significantly correlated with RILK. There was no difference in grade-3+ adverse events between groups.Exploratory analysis: a trend towards increased Event-Free-Survival (two-year: 75.0% (SE = 10.8%) versus 59.8% (SE = 11.2%), p=0·10) and Overall Survival (two-year: 93.4% (SE=6.1%) versus 69.4% (SE=10.5%), p=0·14) was observed with optimized-planning compared to standard-planning in treatment naïve patients. Conclusions Significant RT dose reductions to immune-rich-organs in lung SBRT with comparable-safety is achievable, markedly preserving lymphocytes compared to standard-of-care. (Funded by National Cancer Institute and others. ClinicalTrials.gov number, NCT04273893).

BACKGROUND:Infants and toddlers with perinatal arterial ischemic stroke face a high risk for lifelong neuromotor impairments and multiple disabilities. Phase 3 clinical trial evidence is urgently needed to identify efficacious treatment to improve outcomes. METHODS:The I-ACQUIRE Phase 3 trial (Perinatal Arterial Stroke: A Multisite RCT of Intensive Infant Rehabilitation) is a 15-site randomized clinical trial of 2 dosages of I-ACQUIRE, a multicomponent, therapist-delivered intervention including key components of constraint-induced movement therapy compared with usual and customary treatment. The trial recruited children 8 to 36 months old with parent-reported perinatal arterial ischemic stroke, hemiparesis, good health, and no prior botulinum toxin or constraint-induced movement therapy. Central 1:1:1 randomization assigned children to High-dose I-ACQUIRE (6-hour sessions, 5 days/wk, 4 weeks), Moderate-dose I-ACQUIRE (3-hour sessions, 5 days/wk, 4 weeks), and Usual and Customary Treatment. Blinded assessments at baseline, end-of-treatment, and 6-months later include the Emerging Behaviors Scale (success defined as % with gains ≥7 points), the primary outcome for unilateral skills on the paretic arm-and-hand; and the Mini-Assisting Hand Assessment, the secondary outcome for bimanual activities. Parents also rate children's motor skills, treatment responses, and stress. Statistical analyses include 2-sample binomial tests for group differences and linear mixed regression models. The registered trial adheres to international trial reporting guidelines and has a parent council. RESULTS:This study protocol describes intervention components plus training and monitoring of treatment fidelity. The trial recruited N=216 children; 198 completed baseline assessments, and 168 (85 boys and 83 girls) qualified for the modified intent-to-treat sample. The mean age was 18.0 (SD=7.6) months. A majority had right-sided paresis (70%); 51% had seizures/epilepsy. Children varied widely in functional classification levels and parent ratings. CONCLUSIONS:The trial sets a unique high threshold for efficacy and proposes sensitivity and exploratory analyses to consider differential response patterns to treatment. If 1 or both I-ACQUIRE dosages lead to significant improvements, then Phase 3 evidence will assist in infant/toddler rehabilitation decision-making. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03910075.

Protein phosphatase 2A (PP2A) B55α is required for angiotensin type 2 receptor (AT 2 R) natriuretic signaling and AT 2 R intracellular trafficking in renal proximal tubule cells (RPTCs). RPTC PP2A B55α is thus a key AT 2 R signaling intermediate and potential therapeutic target to promote sodium excretion in hypertensive individuals. This study introduces knocking down B55α in vivo specifically in RPTCs using renal interstitial infusion of siRNA as a novel and unique approach to investigate physiological protein function in the kidney.

Ongoing efforts to optimize the dosages of oncology drugs have largely focused on the initial indication, with emphasis placed on maximizing the utility of all available evidence to improve dose finding, dose selection, and trial design; however, optimizing dosages for new combinations or subsequent indications is more complex and warrants further discussion. For example, the dose-response (DR) or exposure-response (ER) relationships can change when multiple drugs are used (combination therapies) and can differ between tumor types, patient populations, and treatment settings (subsequent indications). Quantitative approaches can help address the challenges of optimizing dosages for new combinations or subsequent indications. To further this dialogue, the US Food and Drug Administration's Office of Clinical Pharmacology and the International Society of Pharmacometrics co-sponsored a workshop to discuss the development of investigational and approved drugs in new combinations or for subsequent indications using model-informed approaches to investigate, support, and select optimized dosages for oncology drugs.

Though several studies have demonstrated that preoperative oral feeding (PO) can be safe in patients with congenital heart disease, they are commonly prohibited from doing so, potentially precluding the development of such skills. We sought to determine whether preoperative oral feeding is associated with freedom from tube feeding at postoperative discharge. Single-center, observational study including patients in the first month of life (≤ 30 days of age) who underwent a single cardiac surgery between 7/1/2017–6/30/2022 and survived to discharge. Preoperative PO was defined as any oral intake up to the day of cardiac surgery. General demographics and peri-operative characteristics were analyzed. A total of 235 patients were included of which 178 (78

Background: We sought to estimate the impact, acceptance, and additional cost of opportunistic bilateral salpingectomy (OBS) or bilateral salpingo-oophorectomy (BSO) during certain non-gynecologic procedures on the incidence of high grade serous ovarian cancer (HGSOC). STUDY DESIGN: US population and institutional data were reviewed for three common laparoscopic nongynecologic surgeries: Cholecystectomy (CCY), Ventral Hernia Repair (VHR), and Bariatric Surgical Procedures (BSP). Additionally, institutional review was performed on all patients, aged 35-75, undergoing these procedures from July 2016 to June 2019 to determine candidacy for OBS or BSO. Patients with history of hysterectomy or tubal sterilization were excluded. Baseline population risk (1.4%) and estimated risk reduction associated with OBS (65%) and BSO (98%) were applied to determine the impact OBS or BSO would have on incidence if applied as standard of care. Separately, patients were surveyed regarding acceptance of concurrent risk reducing procedure. Cost effective analysis (CEA) was performed using multiple models which evaluated participation of Surgery, OB/GYN, and both. Results: For the institutional review, 765 cases were identified, with 417 eligible. Extrapolating the percentage of eligible female patients from our institution undergoing CCY (63 %), VHR (57 %), and BSP (81 %) to reported annual US cases, resulted in eligible cases as follows: CCY (472,500), VHR (199,500-285,000), and BSP (184,680). Therefore, we estimate 466,891---513,488 eligible patients per year. Assuming 20,400 new ovarian cancer (OC) cases annually, between 4,248 and 4,839 cases would be eliminated (20.8-23.7 % reduced incidence). Fifty-nine patients were surveyed (13 AA, 2H) with acceptance rate of 81 %. CEA revealed that multiple models for institution of this practice would favor implementing risk reducing surgery, with OBS performing better than BSO. Conclusion: Over half of female patients undergoing three common non-gynecologic abdominal surgeries could benefit from OBS or BSO. If logistics can be arranged between surgeons and their patients, incidence of OC could be reduced by at least 20-25%.

Purpose:Radiation Therapy (RT) can modulate the immune system and generate anti-tumor T cells. However, this anti-tumor-activity is countered by radiation-induced immunosuppression (RIIS). Clinical advantages of proactively sparing RT dose to immune rich organs have not previously been evaluated. Methods:We conducted a phase II randomized trial from 2020 to 2023, enrolling 51 early-stage lung cancer patients treated with SBRT, to evaluate the effect of dose reduction to immune rich organs on RIIS. Two groups were: RIIS-optimized-treatment (lowering the dose to blood, bone-marrow and lymph-node-stations) and standard-treatment. All treatments followed national protocol guidelines. Peripheral blood was collected at baseline, immediately, 4-weeks and 6-months post-treatment. Results:ALC changes from baseline immediately, 4-weeks and 6-months post-SBRT are: optimized-arm: -16%, -22%, -16%, standard-arm: -31%, -34%, -26%, leading to an overall-all-time-point improvement in ALC reduction in the optimized-arm compared to the standard-arm of 13.4 (5.3) % (95% CI, 2.8 to 24.0; p = 0.01). Central tumors had the largest improvement in ALC from baseline: optimized-arm: - 8%, -18%, -14%, standard-arm: -39%, -43%, -47%, leading to an overall-all-time-point improvement in ALC reduction in the optimized-arm compared to the standard-arm of 29.5 (9.6) % (95% CI, 10.1 to 48.9; p = 0.004). Grade 3 lymphopenia occurred in 15.4% of standard arm patients but was absent in the optimized arm. Additionally, 2.8 times more patients in the optimized arm experienced an ALC increase post-SBRT. Dose to organs such as the heart, great vessels, thoracic spine, and lymph nodes significantly correlated with RIIS. A trend towards increased Event-Free-Survival (two-year: 75.0% (SE = 10.8%) versus 59.8% (SE = 11.2%), p =0·10) and Overall Survival (two-year: 93.4% (SE=6.1%) versus 69.4% (SE=10.5%), p =0·14) was observed with optimized-planning compared to standard-planning in treatment naïve patients. Conclusion:Reducing RT dose to immune rich organs significantly reduces RIIS compared to standard-of-care. This has implications in enhancing immune system mediated anti-tumor-activity. (Funded by National Cancer Institute and others. ClinicalTrials.gov number, NCT04273893 ).

This paper proposes a phase-I clinical trial design that uses ordinal toxicity to locate group-specific doses when groups are partially or completely ordered prior to the start of the trial. There has been previous work on dose-finding for groups and on dose-finding with ordinal toxicity but a solution to the problem of dose-finding for groups with ordinal toxicity has not been proposed. Simulations compared the proposed method against two methods; one that uses ordinal toxicity but does not use group information and one that uses group information but does not use ordinal toxicity. One issue with the first method is the potential for reversals, when the recommended dose for a more sensitive group is higher than the recommended dose for a less sensitive group. The proposed method avoids reversals, allocates patients to optimal doses more frequently during the trial, and selects optimal doses more frequently at the end of the trial.

This paper proposes a trial design for locating group-specific doses when groups are partially or completely ordered by dose sensitivity. Previous trial designs for partially ordered groups are model-based, whereas the proposed method is model-assisted, providing clinicians with a design that is simpler. The proposed method performs similarly to model-based methods, providing simplicity without losing accuracy. Additionally, to the best of our knowledge, the proposed method is the first paper on dose-finding for partially ordered groups with convergence results. To generalize the proposed method, a framework is introduced that allows partial orders to be transferred to a grid format with a known ordering across rows but an unknown ordering within rows.

Purpose/Objective(s) Radiation Therapy (RT) induced immune suppression (RIIS) correlates with worsened overall survival in pancreatic cancer patients. However, there is no computational model to predict RIIS. We evaluated lymphocyte reduction from RT in pancreatic cancer as a function of dose volume data to abdominal regional nodes and critical structures, hypothesizing that there are differential degrees of RIIS among these critical structures. Materials/Methods We analyzed 69 patients who received radiation therapy to the pancreas, including 63 patients who received concurrent chemotherapy. The abdominal CT scans used for planning each patient’s radiation dose were obtained, and structures of interest were manually contoured, including the heart, inferior vena cava, aorta, celiac axis, superior mesenteric artery, liver, duodenum (when present), bowel bag, kidneys, portal vein, spleen, stomach, and vertebral bodies per the RTOG contouring atlas. To identify regional lymph node basins, expansions were performed on the aorta, superior mesenteric artery, celiac trunk and portal vein. Lymphocyte information was obtained from these patients prior to treatment and at 3-month intervals. For each patient and critical structure, integral dose, dose volumes: V1-V50, PTV volume, and dose fractionation were extracted, along with degree of radiation exposure. Associations between RIIS and dose administered to each structure of interest were then assessed using Spearman rank correlations. Data on overall survival were analyzed using Cox-regression, and chi-squared tests. Results Maximum lymphocyte reduction was found at day 35 following initiation of RT, which represented a 78.4% reduction from Pre-Tx ALC value, including 81.2% with ≥ 3 lymphopenia. This reduction remained 65% of pretreatment values at day 185. Number of fractions of RT correlated with RIIS. In addition, significant correlations were found for spleen (mean-dose, integral-dose, V1-V10), liver (V1-V10), R Kidney (integral dose, V1-V15), duodenum (V15-V40), lymph-node-stations (V1-V30), external-PTV (V1-V10), and PTV volume. Acute-long-term-RIIS correlated with right kidney (V20-V30), and duodenum (integral-dose, V1-V40). On multivariate cox regression analysis, minimum post treatment lymphocyte count < 0.2 (G4 lymphopenia) correlated with OS, though it did not reach statistical significance (p = 0.15). Conclusion Our data indicate that acute RIIS correlates with dose to spleen, liver, kidneys, and duodenum and prolonged RIIS correlates with dose to right kidney and duodenum. Optimizing treatment planning to limit doses to these structures may improve outcomes in pancreatic cancer patients. Future studies are indicated to investigate the role of this hypothesis generating work.

Background Sepsis is the leading cause of global mortality, and it is frequently attributed to lower respiratory tract infections and subsequent acute respiratory distress syndrome (ARDS). Patients from sub-Saharan Africa (sSA) are underrepresented in existing studies of sepsis, and little is known about ARDS in sSA. Severe respiratory distress (SRD) is a surrogate for ARDS defined by the WHO as O2 saturation 30 breaths/minute and a systolic blood pressure >90 mmHg plus suspected infection in the absence of cardiac failure. In the context of the current COVID-19 pandemic, a better understanding of SRD in sSA is urgently needed. In this study, we aimed to determine the prevalence, clinical characteristics, and in-hospital mortality of adults with SRD in sSA. Methods We analyzed pooled individual-level data from 16 studies of hospitalized patients conducted in 6 countries throughout sSA from 2009 to 2019. We used multiple imputation with chained equations with 10 iterations to impute missing data. We performed multivariable logistic regression to estimate associations between patient vital signs, laboratory studies, SRD, and in-hospital mortality. We characterized factors associated with in-hospital mortality in the subset of patients with SRD. Results The pooled data included 7385 patients with a median age of 37 years, of whom 3584 (49%) were women, 2282 (31%) were living with HIV, 3190 (43%) had a known acute infection, and 946 (13%) had SRD. The mortality for the total population and for patients with SRD was 15% and 22%, respectively. Older age, lower temperature, increased heart rate, increased respiratory rate, decreased oxygen saturation, Glasgow Coma Scale score <15, HIV infection, and SRD were associated with increased in-hospital mortality. For every increase of 5 breaths/minute, there was a 72% increase in the odds of in-hospital mortality, and conversely for every 1% increase in O2 saturation there was a 5% reduction in the odds of in-hospital mortality. In a subset of patients with available laboratory values, decreased hemoglobin and increased lactate were independently associated with increased inhospital mortality. We found similar associations with in-hospital mortality in the subset of patients with SRD. Conclusions In the first comprehensive evaluation of the prevalence, characteristics, and outcomes of hospitalized patients from sSA with WHO-defined SRD, we found that the prevalence of SRD was high and independently associated with in-hospital mortality. These findings can serve as a benchmark for future studies of patients with SRD in sSA including those with COVID-19.

Background: Sleep disturbance in MS is common and can significantly impair overall quality of life. The ketogenic diet (KD) associates with improved sleep quality in people living with epilepsy and may have similar benefits when used within MS; however, the impact of a KD on sleep in this population remains poorly defined. Methods: Forty-five patients with relapsing MS enrolled into a 6-month KD intervention trial and completed selfreported assessments of sleep quality and sleep disorder symptoms prior to diet initiation and while on diet, using the Epworth Sleepiness Scale (ESS) and Sleep Disorders Symptom Checklist-25 (SDS). Participants who did not complete sleep assessments at baseline and 6-months were excluded from analysis. In addition to sleep metrics, data collection included anthropometrics and MS-related fatigue scores. Results: Thirty-nine of 45 (87 %) participants completed the required sleep assessments. There was a mean reduction in ESS score of 1.90 (95 % CI [-2.85, -0.94], p < 0.001). Total SDS score decreased at 6-months on KD (-4.4, 95 % CI [-7.1, -1.7], p = 0.002), with improvements noted in insomnia (-1.55, 95 % CI [-2.66, -0.43], p = 0.008), obstructive sleep apnea (-0.91, 95 % CI [-1.57, -0.25], p = 0.008), and restless leg syndrome screening scores (-1.00, 95 % CI [-1.95, -0.051], p = 0.04). Sleep duration was unchanged on KD. Conclusion: KD associates with improvements in daytime sleepiness, independent of sleep duration, and common comorbid sleep disorders in people living with relapsing MS. The findings herein support the benefits of KD on sleep quality and highlight the potential role of dietary therapeutics for sleep disorders in neurological disease. Trial registration information: Registered on Clinicaltrials.gov under registration number NCT03718247, posted on Oct 24, 2018. First patient enrollment date: Nov 1, 2018. Link: https://clinicaltrials.gov/ct2/show/NCT03718 247?term=NCT03718247&draw=2&rank=1.

Introduction/AimsWe developed a patient- and physician-weighted consensus unit called the adverse event unit (AEU) that quantifies and compares adverse event (AE) burden among any group of medications in neurological patients. In this study we evaluated preliminary validity and feasibility of measuring AE burden with the AEU in myasthenia gravis (MG).MethodsThis is a single-center, prospective, 1-year, observational study of adult MG patients presenting for routine care between April 1, 2021 and March 31, 2022. The MG Activities of Daily Living (MG-ADL), the 15-item MG Quality of Life revised (MG-QOL15r), MG-Composite, and AEU scores were obtained at all visits. A priori primary feasibility metric was AEU completion rate equal to (within 3.8%, one-sided 95% confidence interval [CI]) or better than MG-ADL completion rate. Time to administer AEU and MG-ADL/MG-QOL15r, correlation between AEU total score and MG-QOL15r, and median AEU scores for each MG medication were evaluated.ResultsFifty-four patients completed 67 study visits; side effects were reported at 75% of the visits. The study met the primary feasibility endpoint; AEU and MG-ADL were recorded at all visits. Times to administer the AEU (median 5 minutes) and MG-ADL/MG-QOL15r were similar. We observed a weak correlation of 0.29 (95% CI 0.03 to 0.51, P = .032) between AEU and MG-QOL15r scores. Non-statistically significant differences in median AEU scores were observed among MG medications.DiscussionOur data demonstrate preliminary feasibility and validity of using the AEU to measure AE burden in MG. Future studies will compare AE burden among MG treatments and evaluate clinically meaningful AEU scores in MG.

Introduction Tonsillectomy in the pediatric population can result in a significant amount of postoperative pain. Acetaminophen is a commonly used non-opioid analgesic. Common routes of acetaminophen administration for immediate postoperative tonsillectomy pain are intravenous and oral. Identification of the problem Frontline team members had opposing anecdotal observations concerning which route provided superior immediate postoperative pain relief. Purpose of the Study This study sought to determine which route of acetaminophen (IV or oral) provided optimal analgesia for children s/p tonsillectomy and to evaluate parental satisfaction with pain control interventions. Methodology Primary objectives were to assess if there was a statistically significant difference in pain scores and time to first rescue medication s/p tonsillectomy with or without adenoidectomy between two randomized groups of children aged 3-17 years who received two standards of care:one group received acetaminophen 15 mg/kg IV intraoperatively and the other received acetaminophen 15 mg/kg oral elixir postoperatively (as soon as it was safe for the child to swallow as evidenced by being awake with swallow reflex noted). Evaluation of pain was measured with the FLACC and 0-10 pain rating scales. A secondary objective was to compare parental satisfaction with postoperative pain control (parental satisfaction responses were measured on a Likert scale). Results Data analysis demonstrated that there was no statistically significant difference in pain scores between the two arms of the study. Rescue medications were given less frequently to children in the IV group, although the children receiving IV acetaminophen required the rescue medication sooner than those receiving oral elixir (p=.021). There were no differences in parental satisfaction between the two groups. Discussion The benefit of IV administration was the enhanced bioavailability. The advantage of oral elixir administration was the immediate soothing effect the suspension provided. Also, it was believed that children who received the oral medication postoperatively when they were cognitively aware of what was happening were comforted by knowing that the nurse was actively doing something to help them feel better. Conclusion Oral and IV acetaminophen are equally effective at controlling immediate postoperative discomfort in the pediatric post-tonsillectomy population. Implications for perianesthesia nurses and future research Nurses caring for pediatric postoperative tonsillectomy patients should individualize pain management plans to optimize pain relief and parental satisfaction.

ABSTRACT The purpose of this study is to examine disparities in mental health diagnoses, depression screening, and depressive symptoms in pediatric primary care settings before and during the COVID‐19 pandemic, and to evaluate the use of electronic health records to study temporal trends in pediatric mental and behavioral health (MBH). This is an IRB‐approved, retrospective study of pediatric patients (n = 11,001) who visited three primary care sites at an academic medical center before (2017–2019) and during (2020–2022) the COVID‐19 pandemic. We used logistic regression to compare prevalence of diagnoses, depression screening, and depression symptom scores among demographic groups. This study demonstrates an increase in both PHQ‐9A screening rates and average scores from 2017–2019 to 2020–2022. Despite an increase in overall PHQ‐9A scores, prevalence of mental health diagnoses is lower in 2020–2022 compared to 2017–2019. There were significant disparities in common mental health diagnoses, including higher rates of psychological distress among lower income patients, both before and during the pandemic. In both cohorts, patients classified as African American, Asian, or Other racial groups had a lower prevalence of diagnoses compared to Caucasian patients. However, patients marked as having multiple racial groups had greater levels of diagnoses. There were also lower screening rates among Hispanic patients. Gender non‐conforming patients had a significantly larger burden of psychological distress. This suggests a need for greater equity in routine MBH screening and additional research to better understand the underlying social determinants that may be driving the greater mental health burden for certain marginalized youth. This study also highlights the strengths and challenges of utilizing EHR data to characterize disparities in pediatric mental illness. Although the nature of care delivery in an academic medical center clinic and the limitations of the EHR for collecting relevant data present challenges to this measurement, the EHR is nevertheless a promising tool for measuring and tracking pediatric mental health disparities.

BACKGROUND: Premature infants are at increased risk for cerebral palsy (CP). Early interventions with a motor focus and administered by parents may improve motor outcomes. AIMS: Secondary study evaluating the short-term motor outcomes and risk for CP in very low birthweight (VLBW) infants randomized to multimodal interventions with a motor focus provided by parents versus usual care. STUDY DESIGN: Randomized controlled trial (intervention vs. usual care (control group)) SUBJECTS: Infants (<32 weeks' gestational age (GA) and/or <1500 grams birthweight) born between March 2019 and October 2020. OUTCOME MEASURES: Short-term motor outcomes and risk for CP was evaluated using the Hammersmith Infant Neurological Evaluation (HINE, primary motor outcome), the General Movement Assessment (GMA) and the Test of Infant Motor Performance (TIMP) at 3 months' postmenstrual age (PMA). RESULTS: 70 participants were enrolled (GA 28.3 +/- 2.7 weeks, birthweight 1139.2 +/- 376.6 grams, 64.3% male). The in- person follow-up rate was 73%, lower than expected, in part due to COVID-19 restrictions, resulting in 25 infants (intervention) and 26 infants (control) with outcome data available for analysis. There was not a significant difference in the HINE, GMA or TIMP at 3 months' PMA between groups. CONCLUSION: Multimodal interventions with a motor focus and provided by parents need further investigation to determine if they can improve short-term motor outcomes in VLBW infants. These interventions are evidence-based and the evaluation of broader implementation into routine care is also needed.