Introduction Infants born very preterm (VPT, <32 weeks’ gestation) are at increased risk for neurodevelopmental impairments including motor, cognitive and behavioural delay. Parents of infants born VPT also have poorer mental health outcomes compared with parents of infants born at term.We have developed an intervention programme called TEDI-Prem (Telehealth for Early Developmental Intervention in babies born very preterm) based on previous research. TEDI-Prem aims to improve neurodevelopmental outcomes and parental well-being in children born VPT. Here we present the protocol outlining a multicentre, pragmatic, parallel-group, randomised controlled trial to determine the efficacy of TEDI-Prem plus usual care, compared with usual care alone.Methods and analysis We will recruit 466 VPT infants from the neonatal units of five hospitals in Victoria, Australia. Participants will be randomised, stratified by site of recruitment and multiple births, to TEDI-Prem plus usual care or usual care alone. The TEDI-Prem intervention programme involves 13 sessions across three phases. Phase 1 commences in the neonatal unit with four face-to-face sessions with parent/s and a physiotherapist/occupational therapist. Once discharged from the hospital, sessions across phases 2 and 3 (six and three sessions, respectively) continue via telehealth until infants are 12 months’ corrected age (CA).The primary outcome is the Bayley Scales of Infant and Toddler Development-fourth edition (Bayley-4) Motor Composite Score at 12 months’ CA. Secondary outcomes address other neurodevelopmental domains (Bayley-4 cognitive and language composite score; Infant Toddler Social Emotional Assessment), parental mental health (Depression Anxiety and Stress Scale 21), parent–child interaction (Emotional Availability Scale) and programme cost-effectiveness which encompasses parent quality of life (Short-Form Six-Dimension Quality of Life) and child quality of life (EuroQol Toddler and Infant Populations measure) at 12 and 24 months’ CA.Mean differences between groups will be examined using linear regression for continuous outcomes and logistic regression for binary outcomes. All models will be fitted via generalised estimating equations to account for multiple births and adjusted for the hospital sites.Ethics and dissemination This trial has Royal Children’s Hospital Human Research and Ethics Committee approval (HREC/67604/RCHM-2020) with specific site approval for all participating sites. Findings will be disseminated through peer-reviewed publications, conference presentations, digital and print media and to participants.Trial egistration number This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000364875).

(1) Background: Pulmonary hypertension (PH) increases pulmonary vascular resistance and right ventricular (RV) afterload. Assessment of RV systolic function in PH using RV fractional area change (RV FAC) as a marker directly correlates with mortality and the need for extracorporeal membrane oxygenation (ECMO). However, few studies have assessed neurodevelopmental outcomes. We hypothesize that cardiac RV systolic dysfunction with lower RV FAC is associated with worse neurodevelopmental impairment (NI). (2) Methods: Retrospective study of 42 subjects with PH to evaluate neurodevelopmental outcomes in the first two years of life based on (i) subjective assessment of RV systolic function and (ii) RV FAC, a specific echocardiographic marker for RV function. (3) Results: Subjects from the initial study cohort (n = 135) with PH who had long-term follow-up were divided into RV dysfunction (study, n = 20) and non-RV dysfunction (control, n = 22) groups. RV FAC in the study vs. control group (0.18 vs. 0.25) was lower (p = 0.00017). There was no statistically significant difference in NI either with RV dysfunction or lower RV FAC. Although not significant, RV dysfunction was associated with longer mean duration of mechanical ventilation, time on ECMO, and length of stay. In the initial cohort (135), mortality was 16.3% and the percentage of NI was 62%. (4) Conclusions: Neonatal pulmonary hypertension is associated with a high degree of neurodevelopment impairment. Early RV systolic dysfunction, as identified by RV FAC, was not an optimal predictive biomarker for infants with PH and neurodevelopmental impairment.

Understanding the type and frequency of current neonatal intensive care unit (NICU) therapy services and predictors of referral for therapy services is a crucial first step to supporting positive long-term outcomes in very preterm infants. This study enrolled 83 very preterm infants (<32 weeks, gestational age mean 26.5 ± 2.0 weeks; 38 male) from a longitudinal clinical trial. Race, neonatal medical index, neuroimaging, and frequency of therapy sessions were extracted from medical records. The Test of Infant Motor Performance and the General Movement Assessment were administered. Average weekly sessions of occupational therapy, physical therapy, and speech therapy were significantly different by type, but the magnitude and direction of the difference depended upon the discharge week. Infants at high risk for cerebral palsy based on their baseline General Movements Assessment scores received more therapy sessions than infants at low risk for cerebral palsy. Baseline General Movements Assessment was related to the mean number of occupational therapy sessions but not physical therapy or speech therapy sessions. Neonatal Medical Index scores and Test of Infant Motor Performance scores were not predictive of combined therapy services. Medical and developmental risk factors, as well as outcomes from therapy assessments, should be the basis for referral for therapy services in the neonatal intensive care unit.

INTRODUCTION:The COVID-19 pandemic impacted clinical research worldwide potentially altering research findings. The study purpose was to measure the effect of the pandemic on recruitment, retention, assessment, and intervention completion rates. METHODS:Enrollment and participation data from a clinical trial evaluating efficacy of a physical therapy intervention for high-risk preterm infants were compared across 3 pandemic periods (February 2019 through November 2021). RESULTS:Recruitment, retention, assessment, and intervention completion rates were lowest during the peak pandemic period. CONCLUSIONS:In compliance with the Human Subjects Review Board, and for the participants' and staff safety, transition from in-person to telehealth or hybrid visits was required to continue this longitudinal study. Despite the negative effect of the pandemic, parental resilience and commitment to the study was clear. Flexibility, quick action, dedication, and efficiency of the research team were key elements enabling study continuation with successful transition to telehealth assessments/interventions during the peak pandemic period.

Infants born very preterm (VPT; ≤29 weeks of gestation) are at high risk of developmental disabilities and abnormalities in neural white matter characteristics. Early physical therapy interventions such as Supporting Play Exploration and Early Development Intervention (SPEEDI2) are associated with improvements in developmental outcomes. Six VPT infants were enrolled in a randomised clinical trial of SPEEDI2 during the transition from the neonatal intensive care unit to home over four time points. Magnetic resonance imaging scans and fixel-based analysis were performed, and fibre density (FD), fibre cross-section (FC), and fibre density and cross-section values (FDC) were computed. Changes in white matter microstructure and macrostructure were positively correlated with cognitive, motor, and motor-based problem solving over time on developmental assessments. In all infants, the greatest increase in FD, FC, and FDC occurred between Visit 1 and 2 (mean chronological age: 2.68–6.22 months), suggesting that this is a potential window of time to optimally support adaptive development. Results warrant further studies with larger groups to formally compare the impact of intervention and disparity on neurodevelopmental outcomes in infants born VPT.

Therapies for children with cerebral palsy (CP) often fail to address essential components of early rehabilitation: intensity, child initiation, and an embodied approach. Sitting Together And Reaching To Play (START-Play) addresses these issues while incorporating intensive family involvement to maximize therapeutic dosage. While START-Play was developed and tested on children aged 7–16 months with motor delays, the theoretical construct can be applied to intervention in children of broader ages and skills levels. This study quantifies the impact of a broader START-Play intervention combined with Botulinum toxin-A (BoNT-A) and phenol on the developmental trajectory of a 24 month-old child with bilateral spastic CP. In this AB +1 study, A consisted of multiple baseline assessments with the Gross Motor Function Measure-66 and the Assessment of Problem Solving in Play. The research participant demonstrated a stable baseline during A and changes in response to the combination of BoNT-A/phenol and 12 START-Play sessions during B, surpassing the minimal clinically important difference on the Gross Motor Function Measure-66. The follow-up data point (+1) was completed after a second round of BoNT-A/phenol injections. While the findings suggest the participant improved his gross motor skills with BoNT-A/phenol and START-Play, further research is needed to generalize these findings.

AimTo synthesize the existing literature and determine the efficacy of neonatal therapy, starting in the neonatal intensive care unit (NICU), on the motor, cognitive, and behavioral outcomes of infants born preterm.MethodDatabases were searched for randomized controlled trials or quasi‐randomized controlled trials of direct therapy early intervention for infants with a gestational age of less than 37 weeks, initiated in the NICU and delivered by a therapist or parent with therapist support. Quality was evaluated using the Cochrane standardized risk of bias assessment tool. Recommendations were made using the Grading of Recommendations, Assessment, Development and Evaluations approach.ResultsFifteen studies met the inclusion criteria. Studies were categorized into four intervention categories: (1) parent‐delivered motor intervention (PDMI); (2) therapist‐delivered postural control intervention (TDPCI); (3) developmental care; and (4) oromotor intervention. Risk of bias varied from low (10 studies) to high (three studies) or was unclear (two studies).InterpretationPreliminary support indicates that daily PDMI improves motor and cognitive outcomes in the short‐term and possibly long‐term. TDPCI is effective in promoting short‐term gains in motor development. Developmental care programs designed by a neonatal therapist appear to be effective in improving short‐term behavior but are inconclusive for motor and cognitive outcomes or long‐term behavioral outcomes. Regarding oromotor interventions, there is insufficient research to be confident in their efficacy on improving developmental outcomes.What this paper adds Parent‐delivered motor interventions (PDMIs) are more effective in improving motor and cognitive outcomes than other interventions. Preliminary support indicates that daily PDMI improves motor and cognitive outcomes in the short‐ and possibly long‐term. Therapist‐delivered postural control interventions are effective in promoting short‐term gains in motor development. Developmental care programs designed by a neonatal therapist are effective in improving the short‐term behavior of infants born preterm. Oral motor interventions were found to have no effect on improving developmental outcomes.

Objective. The aim of this project is to study the effect of a physical therapist intervention provided in the first months of life on developmental outcomes of infants born very preterm. Secondary aims are to investigate the impact of intervention timing on the efficacy and impact of the intervention on infants with and without cerebral palsy. Methods. This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the Supporting Play, Exploration, and Early Development Intervention (SPEEDI)_Late or SPEEDI_Early group to a usual care group. Settings are urban. Urban and rural areas surrounding 2 academic medical centers. There will be 90 preterm infants enrolled in this study born at <29 weeks of gestation. SPEEDI is a developmental intervention provided by collaboration between a physical therapist and parent to support a child's motor and cognitive development. The primary outcome measure is the Bayley Scale of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores. Secondary measures include behavioral coding of early problem solving skills, the Gross Motor Function Measure, and Test of Infant Motor Performance. Impact. More than 270,000 infants are born very preterm in the United States each year, 50% of whom will have neurological dysfunction that limits their ability to keep pace with peers who are typically developing. This study is a step toward understanding the impact that intensive developmental intervention could have in this population in the first months of life.

Knowledge translation is the process by which we take new information that is evidence based and incorporate it into our practice. While we can each incorporate evidence into our practice, the collaboration between a researcher and a clinician can advance the implementation of evidence-based practice. We highlight the use of the Plan-Do-Study-Act cycle that includes a researcher and clinical partner on a journey of research question development, knowledge generation, clinical implementation, and policy change that advances the care to infants in the neonatal intensive care unit and in a developmental follow-up clinic. The team provides examples of implementation and highlights the clinical care differences following a decade of collaboration. Pediatric physical therapists have a responsibility to embrace and support knowledge translation to advance our profession and the care of infants, children, and families.

Parents are their infant's first teachers and play a very important role in early development. Early intervention strives to enhance infant participation in the family, and regulations require the engagement of families in assessment and intervention. Infants born preterm or with motor impairments demonstrate altered social engagements that can influence parent-child interaction and the efficacy of therapy services. However, in research focused on the efficacy of interventions or in clinical practice, therapists rarely assess or report on the quality of parent-infant interaction. Understanding these interactions can help determine what perceptual motor opportunities parents provide that can enhance learning. This Perspective article will: (1) present evidence on the need for early assessment and ongoing measurement of parent-infant interaction; (2) describe an example of each of 3 methods for assessment of parent-child interaction-low-tech, low-resource (Dyadic Mutuality Code), low-tech, high-resource (Parent Children Early Relational Assessment), and high-tech, high-resource (customized behavioral coding); (3) compare 3 approaches theoretically highlighting the strengths and weaknesses of each assessment; and (4) reflect on the challenges and value of adding these measures to future research on the efficacy of interventions and clinical practice.

Background and Purpose Infants born preterm are at high risk of developmental disabilities and benefit from early developmental intervention programs. Physical therapists with neonatal expertise are ideally suited to educate parents about ways to support their infant's development in the first months of life. However, administrative policies are needed to support the therapist in providing adequate parent education in the neonatal intensive care unit (NICU). This administrative case report describes the process used by a team of neonatal therapists to evaluate clinical practice, determine the need for change, and develop and implement a new parent education program in the NICU. Case Description Physical therapy parent education practices were evaluated in an academic medical center with a 36-bed, level-3 NICU. Physical therapists with neonatal expertise covered multiple units within the hospital each day. A series of focus groups, a small descriptive study, and staff discussion were used to evaluate parent education practices in this academic medical center. A new parent education program was developed based on data collected and literature to improve clinical care. Outcomes The new parent education model was implemented over the course of several months using overlapping initiatives. Administrative support for the change was developed through collaboration, open communication, and presentation of clinical data. In addition, this hospital-based program contributed to the development of a statewide initiative to educate parents of preterm infants about the importance of supporting development in the first months of life. Discussion A collaborative and data-driven approach to evaluating parent education practices supported the development of a new parent education practice while acknowledging the need to meet staff productivity standards and provide excellent care throughout the hospital.