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Tanya Tripathi,1 Stacey C Dusing2,3 1Rehabilitation and Movement Science Program, Department of Physical Therapy, 2Department of Physical Therapy, 3Department of Pediatrics, Children's Hospital of Richmond, Virginia Commonwealth University, Richmond, VA, USA Purpose: Late preterm (LPT) births constitute a large proportion of the preterm births in the USA. Over the last few decades, there has been an increase in research focusing on the neurodevelopment of infants born LPT. The purpose of this research was to systematically review the long-term neurodevelopmental outcomes in LPT infants. Materials and methods: We identified studies by using PubMed, ERIC, CINAHL, and PsycINFO databases. The references of included papers were reviewed for additional papers that met the inclusion criteria. Included papers compared motor, cognitive, language development, or academic performance outcomes between individuals born LPT and a term control group assessed between 12 months and 18 years of age. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses standards for systematic reviews were utilized including a two-step, two-investigator review process. Results: Of the 4,720 studies found in the initial search, 20 studies met the inclusion criteria. Approximately 75% of the 16 studies that assessed cognitive outcomes reported cognitive delay in the LPT group when compared to their full-term counterparts. More than 50% of the seven studies that assessed motor outcomes suggested a delay in motor development in the LPT group in comparison to full-term. Fewer papers assessed academic performance and language in children born LPT; however, the majority identified borderline differences when LPT infants were compared to those born full-term. Conclusion: Evidence suggests that infants born LPT are at an increased risk of neurodevelopmental delay between 1 and 18 years of life when compared to those born at term. The delay is most evident in the cognitive domain of neurodevelopment. Children born LPT are also at a risk of delayed language development, motor development, and lower academic performance. The rate of developmental delay is reduced somewhat when controlling for social factors; however, group differences persist. Keywords: late preterm infants, developmental outcomes, motor development, cognitive development, language development and school performance

Mothers of infants born extremely preterm requiring prolonged medical intervention in the Neonatal Intensive Care Unit (NICU) are at high risk of developing stress. Parent-administered infant massage is a well-established, safe intervention for preterm infants with many developmental benefits, but the published literature has mostly examined its impact on infants and parents through self-reported or observational measures of stress. The aim of this study was to measure salivary cortisol, a biomarker for stress, in extremely preterm infants and their mothers immediately pre and post parent-administered infant massage in order to detect potential changes in physiologic stress. Twenty-two mother-infant dyads completed massage education with a physical or occupational therapist. All dyads provided salivary cortisol samples via buccal swab immediately pre- and post-massage at the second session. Of mothers determined to be "cortisol responders" (15/22), salivary cortisol levels were lower after massage (pre-minus post-level: -26.47 ng/dL, [CI = -4.40, -48.53], p = .016, paired t-test). Our primary findings include a clinically significant decrease (as measured by percent change) in maternal cortisol levels immediately post parent-administered massage, indicating decreased physiological stress. Integration of infant massage into NICU clinical practice may support maternal mental health, but further powered studies are necessary to confirm findings., (© 2023 Michigan Association for Infant Mental Health.)

The Baby Bridge program is an implementation strategy to improve access to in-person early therapy services following neonatal intensive care unit (NICU) discharge. The objective of this study was to evaluate acceptability of Baby Bridge telehealth services among health care providers. Interviews with health care providers were conducted, transcribed, and coded in NVivo. Deductive analysis was used to organize data into negative and positive comments, suggestions for optimization, and perceptions about the first visit. Next, a conventional approach was used to organize the data into themes. Telehealth was viewed as an acceptable, but not necessarily preferable, form of Baby Bridge delivery. Providers identified how telehealth may improve access to care, but with potential challenges in delivery. Suggestions for optimization of the Baby Bridge telehealth model were proposed. Identified themes included delivery model, family demographics, therapist and organizational characteristics, parent engagement, and therapy facilitation. These findings provide important insights to consider when transitioning from in-person therapy to telehealth.

Aims: Children with neuromotor delays are at risk for reaching and object exploration impairments, which may negatively affect their cognitive development and daily activity performance. This study evaluated the effectiveness of the Sitting Together And Reaching To Play (START-Play) intervention on reaching-related exploratory behaviors in children with neuromotor delays., Methods: In this randomized controlled clinical trial, 112 children ( Mean  = 10.80, SD  = 2.59 months old at baseline) with motor delays were randomly assigned to receive START-Play intervention or usual care-early intervention. Performance for ten reaching-related exploratory behaviors was assessed at baseline and 1.5, 3, 6, 12 months post-baseline. Piecewise linear mixed-effects modeling was used to evaluate short- and long-term effects of the intervention., Results: Benefits of START-Play were observed for children with significant motor delays, but not for those with mild delays. START-Play was especially beneficial for children with significant motor delays who demonstrated early mastery in the reaching assessment (i.e., object contact ≥65% of the time within 3 months after baseline); these children showed greater improvements in manual, visual, and multimodal exploration, as well as intensity of exploration across time., Conclusions: START-Play advanced the performance of reaching-related exploratory behaviors in children with significant motor delays.

Importance: Cerebral palsy (CP) is the most common childhood physical disability. Early intervention for children younger than 2 years with or at risk of CP is critical. Now that an evidence-based guideline for early accurate diagnosis of CP exists, there is a need to summarize effective, CP-specific early intervention and conduct new trials that harness plasticity to improve function and increase participation. Our recommendations apply primarily to children at high risk of CP or with a diagnosis of CP, aged 0 to 2 years., Objective: To systematically review the best available evidence about CP-specific early interventions across 9 domains promoting motor function, cognitive skills, communication, eating and drinking, vision, sleep, managing muscle tone, musculoskeletal health, and parental support., Evidence Review: The literature was systematically searched for the best available evidence for intervention for children aged 0 to 2 years at high risk of or with CP. Databases included CINAHL, Cochrane, Embase, MEDLINE, PsycInfo, and Scopus. Systematic reviews and randomized clinical trials (RCTs) were appraised by A Measurement Tool to Assess Systematic Reviews (AMSTAR) or Cochrane Risk of Bias tools. Recommendations were formed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework and reported according to the Appraisal of Guidelines, Research, and Evaluation (AGREE) II instrument., Findings: Sixteen systematic reviews and 27 RCTs met inclusion criteria. Quality varied. Three best-practice principles were supported for the 9 domains: (1) immediate referral for intervention after a diagnosis of high risk of CP, (2) building parental capacity for attachment, and (3) parental goal-setting at the commencement of intervention. Twenty-eight recommendations (24 for and 4 against) specific to the 9 domains are supported with key evidence: motor function (4 recommendations), cognitive skills (2), communication (7), eating and drinking (2), vision (4), sleep (7), tone (1), musculoskeletal health (2), and parent support (5)., Conclusions and Relevance: When a child meets the criteria of high risk of CP, intervention should start as soon as possible. Parents want an early diagnosis and treatment and support implementation as soon as possible. Early intervention builds on a critical developmental time for plasticity of developing systems. Referrals for intervention across the 9 domains should be specific as per recommendations in this guideline.

We propose that the collection of infant experiential and environmental data using smartphone surveys has the potential to fill a gap in foundational and clinical knowledge. To achieve this, these data need to be collected in a systematic way that is translatable globally. We can then begin to understand differences in child development and physical therapy from a variety of cultures and traditions. An infant's development is shaped by experiences in everyday life, and everyday experiences vary around the world. Hence, it is important to quantify these experiences to better understand variability in developmental trajectories. Recent increase in smartphone access has made the capability of collecting infant experiential data more feasible around the world. We provide examples and suggestions for ways in which experiential and environmental data can be collected for future practice., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Academy of Pediatric Physical Therapy of the American Physical Therapy Association.)

Background: Associative learning is the ability to discover a relationship between two or more events. We combined principles of learning and technology to develop a paradigm to assess associative learning in prone., Purpose: The purpose of this study was to determine whether 3- to 6-month-old infants can demonstrate: (1) short-term learning of an association between their upper body movements in prone and activation of a toy, and (2) retention of the association learned on day 1, 24 hours later., Methods: Twenty-eight infants who were 3 to 6 months of age and who were typically developing were tested for 2 consecutive days in an instrumented play gym. Both days of testing had a baseline and 4 acquisition phases (2 minutes each). During the acquisition phase, the toy activated for a maximum of 10 seconds when the infant's head was above a threshold. A criterion was set a priori to distinguish infants as short-term learners and retainers of the association learned on day 1., Results: Of 28 infants, 22 and 14 infants completed all phases of the testing on day 1 and day 2, respectively. Fourteen (50%) of the infants met the criteria for short-term learners. On day 2, there was an analyzable sample of 9 short-term learners. Three of the 12 short-term learners (25%) demonstrated retention on day 2., Conclusion: Consistent with prior infant motor learning research, half of the infants demonstrated associative learning in this novel assessment in prone; however, based on study criteria, the infants had limited retention of the association on day 2., (© 2019 American Physical Therapy Association.)

Knowledge about associated service utilization patterns and positive outcomes in children with cerebral palsy (CP) of varying levels of severity is a national priority. Families, clinicians, program directors, and policy makers need this information for clinical decision-making and service planning. Existing data sources in the United States that contain information about children with CP, their health, function, well being, and utilization of health services may add to our existing knowledge. We provide a summary of fourteen national, state, and local sources' data: where the data come from, challenges and/or specific considerations when using or accessing information, and specific data elements included. Currently available sources of data can provide meaningful information for policy, practice, and program development. We propose questions for future inquiry and suggest elements that may be useful for when developing data sources specific to physical therapy and individuals with CP. A physical therapy specific registry is warranted.

Typically developing children frequently participate in community recreation activities that enhance their social/emotional and physical development. The inclusion of children with developmental disabilities in these activities continues to be a challenge. This case report investigated the feasibility of including a child with Down syndrome in a community performing arts program. The participant is an 11-year-old female with Down syndrome and mild cognitive impairment. The participant was enrolled in a 14-week performing arts session that included a combination of acting, voice, and dance instruction. She participated in the program with the support of a one-on-one assistant who was a physical therapy student. The assistant facilitated learning the choreography, appropriate socialization, and positioning on the stage. Peer helpers were used to allow for greater independence toward the end of the session and for the final performance. The participant completed the final performance without the one-on-one assistant. The participant's mother completed the PedsQL before and after the performance, and the participant's scaled scores increased in all subsets except for emotional function and the total scales score increased from 51 to 57. With appropriate modifications and the right child/program fit, children with developmental disabilities such as Down syndrome can successfully be included in community programs. Physical therapists can assist families and community programs to make developmentally appropriate modifications to enhance participation.

An adventitious agent contamination occurred during a routine 9 CFR bovine viral screening test at BioReliance for an Eli Lilly Chinese Hamster Ovary (CHO) cell-derived Master Cell Bank (MCB) intended for biological production. Scientists from the sponsor (Eli Lilly and Company) and the testing service company (BioReliance) jointly conducted a systematic investigation in an attempt to determine the root cause of the contamination. Our investigation resulted in the identification of the viral nature of the contaminant. Subsequent experiments indicated that the viral contaminant was a non-enveloped and non-hemadsorbing virus. Transmission electron microscopy (TEM) revealed that the viral contaminant was 25-30 nm in size and morphologically resembled viruses of the family Picornaviridae. The contaminant virus was readily inactivated when exposed to acidic pH, suggesting that the viral contaminant was a member of rhinoviruses. Although incapable of infecting CHO cells, the viral contaminant replicated efficiently in Vero cell with a life cycle of approximately 16 h. Our investigation provided compelling data demonstrating that the viral contaminant did not originate from the MCB. Instead, it was introduced into the process during cell passaging and a possible entry point was proposed. We identified the viral contaminant as an equine rhinitis A virus using molecular cloning and DNA sequencing. Finally, our investigation led us to conclude that the source of the viral contaminant was the equine serum added to the cell growth medium in the 9 CFR bovine virus test.

Product safety testing for retroviruses can be achieved by a panel of screening assays, including electron microscopy, viral gene specific PCRs, virus propagation, and detection of reverse transciptase activity. The application of PCR-based reverse transcriptase assays (PERT) that are approximately a million-fold more sensitive than conventional nucleotide incorporation assays in the testing of biologicals is described. Use of PERT assays can be applied to three areas: (i) screening for adventitious retrovirus contamination; (ii) detecting and quantifying endogenous viral particle load and (iii) monitoring levels of infectious retrovirus generation in cell lines that contain endogenous retroviruses.

Gene therapy to correct defective genes requires efficient gene delivery and long-term gene expression. The available vector systems have not allowed the simultaneous achievement of both goals. We have developed a chimeric viral vector system that incorporates favorable aspects of both adenoviral and retroviral vectors. Adenoviral vectors induce target cells to function as transient retroviral producer cells in vivo. The progeny retroviral vector particles are then able to stably transduce neighboring cells. In this system, the nonintegrative adenoviral vector is rendered functionally integrative via the intermediate generation of a retroviral producer cell. The chimeric vectors may allow realization of the requisite goals for specific gene-therapy applications.

The goal of ex vivo culture is to expand and/or differentiate cells in culture such that they retain their functional characteristics when reinfused into a patient. The studies presented here analyzed the use of culture conditions devoid of serum to expand murine hematopoietic stem cells. Bone marrow cells from male B6D2F1/J mice were cultured for up to 28 days in serum-free medium in the absence or presence of stem cell factor (SCF), GM-CSF or a combination of the two factors. Cells cultured for up to 21 days were assessed for granulocyte-macrophage colony-forming cells (GM-CFC), spleen colony-forming units, and cells responsible for short-term and long-term hematopoietic repopulation in lethally irradiated mice. Compared to initial seeding levels, the presence of SCF and GM-CSF increased total cell numbers 90-fold and GM-CFC numbers 42-fold over a 21-28 day culture period. Although spleen colony-forming unit cells did not increase, they were maintained at initial seeding levels over a 21-day period in the presence of SCF and GM-CSF. In lethally irradiated mice, survival enhancement and hematologic reconstitution were optimum with cells cultured for only seven days: survival at six months was 100% with cells cultured in SCF plus GM-CSF or SCF alone, compared to 50% with cells cultured with only GM-CSF. Hybridization analysis of bone marrow, spleen and thymus DNA from irradiated mice transplanted with these cultured cells confirmed male donor cell-derived repopulation at 45 days and 180 days post-transplant. These studies illustrate that murine GM-CFC can be expanded and that long-term repopulating hematopoietic cells can, at the minimum, be maintained ex vivo in serum-free culture. The use of defined serum-free culture systems holds great promise for further evaluation of the mechanisms that control hematopoietic stem cell proliferation.