Standardized Neurodevelopmental Surveillance of High-risk Infants Using Telehealth: Implementation Study during COVID-19

Maitre, Nathalie L.; Benninger, Kristen; Neel, Mary Lauren; J, Haase; Pietruszewski, Lindsay; Levengood, Katelyn; Adderley, Kathleen; Batterson, Nancy; Hague, Kaleigh; Lightfoot, Megan; Weiss, Sarah J.; Lewandowski, Dennis J.; Larson, Heather

doi:10.1097/pq9.0000000000000439

Cited by 22 publications

(15 citation statements)

References 31 publications

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“…As a trend, the study enrollment rate was highest in the prepandemic period (48%), decreased in the peak pandemic period (26%), and in the late pandemic period started to increase (39%) toward prepandemic rates (Figure 1). A larger number of participants withdrew or were lost to follow-up in the peak pandemic period (10) than in the other 2 pandemic periods (Table 1 and Figure 1). Demographic characteristics did not appear to alter outcomes; however, changes over the study periods did influence the data.…”

Section: Resultsmentioning

confidence: 99%

Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies

Brown,

Miller,

Darring

et al. 2023

Pediatric Physical Therapy

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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.

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Section: Resultsmentioning

confidence: 99%

Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies

Brown,

Miller,

Darring

et al. 2023

Pediatric Physical Therapy

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“…However, long-termfollow-up is required to provide a more accurate picture. Telehealth may be a useful method for monitoring the long-term neurodevelopmental outcomes of neonates who develop SARS-CoV-2 infection [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

Coronavirus Infection in Neonates: Neurodevelopmental Outcomes at 18 Months of Age

Ayed¹,

Alsaffar

Bahzad

et al. 2023

Canadian Journal of Infectious Diseases and Medical Microbiolog

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Background. Although most neonates with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection experience only mild disease, its impact on neurodevelopmental outcomes is unknown. This study aimed to assess the 18-month neurodevelopmental outcomes of infants who had SARS-CoV-2 infection as neonates. Methods. The authors conducted a prospective cohort study of neonates diagnosed with SARS-CoV-2 infection from June 2020 to December 2020 through nasopharyngeal coronavirus disease 2019 (COVID-19). A total of 58 neonates were identified from the Kuwait National COVID-19 Registry and enrolled. Historical controls were selected from the neonatal follow-up registry and matched in a 2 : 1 ratio based on sex and gestational age. When the subjects were 18 months of age, their neurodevelopmental outcomes were assessed by two trained assessors using the Bayley Scales of Infant and Toddler Development-3rd Edition (BSID-III). Results. Forty children diagnosed with SARS-CoV-2 infection were included in the final analysis. The median age at infection was 18 days (range: 10–26 days). Eighteen (45%) patients were asymptomatic, 15 (37.5%) had a sepsis-like presentation, 5 (12.5%) exhibited respiratory distress, and 2 (5%) had a multisystem inflammatory syndrome in children (MIS-C)-like presentation. At the 18 months follow-up, only one child showed a severe developmental delay and one child had a language delay. BSID-III outcomes did not differ significantly between the SARS-CoV-2-infected and control groups. Conclusions There was no difference in neurodevelopmental outcomes at 18 months in children infected with SARS-CoV-2 compared with controls, although longer neurodevelopmental follow-up studies are required.

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“…Had we conducted the assessment in person, research personnel would have been required to use personal protective equipment, including masks and face shields, which may have had substantial implications for performance on the assessment. In addition, the DAYC-2 can be administered remotely for clinical purposes, 30 and the CUIMC neonatal follow-up clinic began administering the DAYC-2 via telehealth visits at the beginning of the pandemic.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Neurodevelopment in Infants With and Without Exposure to Asymptomatic or Mild Maternal SARS-CoV-2 Infection During Pregnancy

Firestein

Shuffrey

et al. 2023

JAMA Netw Open

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ImportanceAssociations between prenatal SARS-CoV-2 exposure and neurodevelopmental outcomes have substantial public health relevance. A previous study found no association between prenatal SARS-CoV-2 infection and parent-reported infant neurodevelopmental outcomes, but standardized observational assessments are needed to confirm this finding.ObjectiveTo assess whether mild or asymptomatic maternal SARS-CoV-2 infection vs no infection during pregnancy is associated with infant neurodevelopmental differences at ages 5 to 11 months.Design, Setting, and ParticipantsThis cohort study included infants of mothers from a single-site prospective cross-sectional study (COVID-19 Mother Baby Outcomes [COMBO] Initiative) of mother-infant dyads and a multisite prospective cohort study (Epidemiology of Severe Acute Respiratory Syndrome Coronavirus 2 in Pregnancy and Infancy [ESPI]) of pregnant individuals. A subset of ESPI participants was subsequently enrolled in the ESPI COMBO substudy. Participants in the ongoing COMBO study were enrolled beginning on May 26, 2020; participants in the ESPI study were enrolled from May 7 to November 3, 2021; and participants in the ESPI COMBO substudy were enrolled from August 2020 to March 2021. For the current analysis, infant neurodevelopment was assessed between March 2021 and June 2022. A total of 407 infants born to 403 mothers were enrolled (204 from Columbia University Irving Medical Center in New York, New York; 167 from the University of Utah in Salt Lake City; and 36 from the University of Alabama in Birmingham). Mothers of unexposed infants were approached for participation based on similar infant gestational age at birth, date of birth, sex, and mode of delivery to exposed infants.ExposuresMaternal symptomatic or asymptomatic SARS-CoV-2 infection.Main Outcomes and MeasuresInfant neurodevelopment was assessed using the Developmental Assessment of Young Children, second edition (DAYC-2), adapted for telehealth assessment. The primary outcome was age-adjusted standard scores on 5 DAYC-2 subdomains: cognitive, gross motor, fine motor, expressive language, and receptive language.ResultsAmong 403 mothers, the mean (SD) maternal age at delivery was 32.1 (5.4) years; most mothers were of White race (240 [59.6%]) and non-Hispanic ethnicity (253 [62.8%]). Among 407 infants, 367 (90.2%) were born full term and 212 (52.1%) were male. Overall, 258 infants (63.4%) had no documented prenatal exposure to SARS-CoV-2 infection, 112 (27.5%) had confirmed prenatal exposure, and 37 (9.1%) had exposure before pregnancy or at an indeterminate time. In adjusted models, maternal SARS-CoV-2 infection during pregnancy was not associated with differences in cognitive (β = 0.31; 95% CI, −2.97 to 3.58), gross motor (β = 0.82; 95% CI, −1.34 to 2.99), fine motor (β = 0.36; 95% CI, −0.74 to 1.47), expressive language (β = −1.00; 95% CI, −4.02 to 2.02), or receptive language (β = 0.45; 95% CI, −2.15 to 3.04) DAYC-2 subdomain scores. Trimester of exposure and maternal symptom status were not associated with DAYC-2 subdomain scores.Conclusions and RelevanceIn this study, results of a novel telehealth-adapted observational neurodevelopmental assessment extended a previous finding of no association between prenatal exposure to maternal SARS-CoV-2 infection and infant neurodevelopment. Given the widespread and continued high prevalence of COVID-19, these data offer information that may be helpful for pregnant individuals who experience asymptomatic or mild SARS-CoV-2 infections.

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Standardized Neurodevelopmental Surveillance of High-risk Infants Using Telehealth: Implementation Study during COVID-19

Abstract: Supplemental Digital Content is available in the text.

Cited by 22 publications

References 31 publications

Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies

Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies

Coronavirus Infection in Neonates: Neurodevelopmental Outcomes at 18 Months of Age

Assessment of Neurodevelopment in Infants With and Without Exposure to Asymptomatic or Mild Maternal SARS-CoV-2 Infection During Pregnancy

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