One-Year Neurodevelopmental Outcomes After Neonatal Opioid Withdrawal Syndrome: A Prospective Cohort Study.

Purpose: The aims of this study were, in a cohort of children with neonatal opioid withdrawal syndrome (NOWS), (a) to report 1-year neurodevelopmental outcomes and specifically characterize speech, language, and hearing outcomes and (b) to report the prevalence of cleft lip and/or cleft palate. Method: This prospective observational cohort study includes newborns with confirmed in utero opioid exposure who received pharmacological treatment for NOWS. During 1-year-old developmental visits, we administered standardized assessments (Bayley Scales of Infant and Toddler Development-Third Edition [Bayley-III] or Developmental Assessment of Young Children-Second Edition [DAYC-2]-due to COVID-19 restrictions). We compared Bayley-III scores to standardized population means using one-sample z tests. We report estimates, 95% confidence intervals, and two-sided p values. Results: We enrolled 202 infants (October 2018 to March 2020). Follow-up at 1-year was 80%. Infants with NOWS had lower Bayley-III scores at 1 year compared to published norms for cognitive, language, and motor domains. One infant with NOWS was diagnosed with isolated cleft palate and Pierre Robin sequence. All infants passed the newborn hearing screen, and 7.5% had a formal hearing evaluation after neonatal intensive care unit discharge, with 40% having abnormal or inconclusive results; middle ear effusion was the leading cause of abnormal hearing (66.7%). Ten percent of children received a speech-language pathology referral prior to 2 years of age. Infants born to mothers with mental health conditions were more likely to have Bayley-III or DAYC-2 scores below 95 in language or motor domains. Conclusions: Infants with pharmacologically treated NOWS have significantly lower cognitive, language, and motor scores on standardized developmental testing compared to population means at 1 year of age. Early speech-language pathology referral is frequently necessary to promote optimal development in this population. Supplemental Material: https://doi.org/10.23641/asha.20044403.

Hammersmith Infant Neurological Examination Clinical Use to Recommend Therapist Assessment of Functional Hand Asymmetries.

PURPOSE: To determine whether asymmetry scores derived from the Hammersmith Infant Neurological Examination (HINE) can provide cutoff scores for recommending in-depth assessment of upper extremity functional deficits by therapists using the Hand Assessment for Infants (HAI). METHODS: Observational study in a clinical laboratory with the HINE and the HAI administered concurrently to 101 infants 3 to 12 months corrected age developing typically or atypically. Predictive value of HINE asymmetry scores for atypical HAI was determined. RESULTS: Total HINE asymmetry scores of 4 or greater had 100% sensitivity and 88% or greater specificity for identifying infants with an asymmetric HAI score of 3 or greater point difference between hands. CONCLUSIONS: For infants receiving a total HINE asymmetry score of 4 or greater, referral to therapists for HAI assessment may be beneficial to precisely evaluate function and determine the need for targeted upper extremity interventions.

Caregiver perception of hand function in infants with cerebral palsy: psychometric properties of the Infant Motor Activity Log.

AIM: To evaluate the properties of the Infant Motor Activity Log (IMAL), a caregiver-report for frequency and quality of use of more affected upper extremity in infants with neurological and functional impairments. METHOD: This was a prospective cohort study of 66 children (34 females, 32 males) aged 6 to 24 months (mean age [SD] 13.7mo [5.3]) with neurological and functional impairments and a confirmed cerebral palsy diagnoses after 2 years, and 51 age-matched typically developing children. The IMAL was administered at baseline and 4 weeks later. Typically developing infants were tested with randomly assigned 'more affected' upper extremity. Psychometric properties were evaluated using Spearman's correlation coefficient, Cronbach's alpha, and Jonckheere-Terpstra tests. RESULTS: In the children with impairments, the IMAL showed internal consistency (alpha≥0.88) for the How Well Scale (HWS) and How Often Scale (HOS). Test-retest reliability was 0.64 (HOS) and 0.70 (HWS), demonstrating stability over time. Correlation with Bayley Scales of Infant and Toddler Development, Third Edition more affected arm raw scores were 0.70 (HOS) and 0.72 (HWS) (p<0.001) demonstrating construct validity. Both scale scores decreased with increasing Gross Motor Function Classification System and Mini-Manual Ability Classification System (p<0.001) levels, supporting discriminative validity. Discrimination between typically developing infants and infants with impairments was high (HWS: area under the receiver operating characteristic curve [AUC] 0.96, 95% confidence interval [CI] 0.94-0.99 and HOS AUC=0.95, CI 0.92-0.99). INTERPRETATION: The IMAL is a valid and reliable discriminative caregiver measure of upper limb performance and may complement measures of capacity in infants with neurological and functional impairments. WHAT THIS PAPER ADDS: The Infant Motor Activity Log (IMAL) is a valid and reliable measure of caregiver perception of upper limb function. The IMAL fills a measurement gap for infant motor performance in children with impairments. The IMAL discriminates among motor function levels.

Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity.

BACKGROUND: Dietary DHA intake among US toddlers is low. Healthy physical growth is an important objective for the clinical care of children born preterm. OBJECTIVES: The aim of the trial was to examine the effects of supplementing toddlers born preterm with DHA and arachidonic acid (AA) for 180 d on growth and adiposity. METHODS: Omega Tots, a randomized placebo-controlled trial, was conducted between April 2012 and March 2017. Children born at <35 wk gestation who were 10-16 mo in corrected age were assigned to receive daily oral supplements of DHA and AA (200 mg each, "DHA + AA") or corn oil (placebo) for 180 d. Prespecified secondary outcomes included weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage, which were measured at baseline and trial completion. Mixed-effects regression was used to compare the change in outcomes between the DHA + AA and placebo groups, controlling for baseline values. RESULTS: Among 377 children included in the analysis (median corrected age = 15.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end. No statistically significant differences between the DHA + AA and placebo groups in growth or adiposity outcomes were observed. For instance, the change in weight-for-age z scores was 0.1 for the DHA + AA group and 0.0 for the placebo group (effect size = 0.01, P = 0.99). However, post-hoc subgroup analyses revealed a statistically significant interaction between treatment group and sex, suggesting somewhat slower linear growth for females assigned to the DHA + AA group compared with the placebo group. CONCLUSIONS: Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo. If DHA supplementation is implemented after the first year of life, it can be expected to have no effect on short-term growth or adiposity. This trial is registered with clinicaltrials.gov as NCT02199808.

Gaps and Factors Related to Receipt of Care within a Medical Home for Toddlers Born Preterm.

OBJECTIVE: To characterize gaps and factors related to receipt of care within a medical home for toddlers born preterm. STUDY DESIGN: Participants were 202 caregivers of children born at <35 weeks of gestation. At 10-16 months of corrected age, caregivers completed the National Survey of Children's Health (2011/2012) medical home module and a sociodemographic profile. Care within a medical home comprised having a personal doctor/nurse, a usual place for care, effective care coordination, family-centered care, and getting referrals when needed. Gestational age and neonatal follow-up clinic attendance were abstracted from the medical record. The Bayley Scales of Infant and Toddler Development, Third Edition assessed developmental status. Log-binomial regression examined factors related to receiving care within a medical home. RESULTS: Fifty-three percent (n = 107) of the children received care within a medical home. Low socioeconomic status (young caregiver: risk ratio [RR] = 0.73; 95% CI 0.55, 0.97; low education: RR= 0.69; 95% CI 0.49, 0.98) and delayed language (RR = 0.63; 95% CI 0.42, 0.95) were associated with a lower likelihood of receiving care within a medical home. Degree of prematurity and neonatal clinic follow-up participation were unrelated to receipt of care within a medical home. CONCLUSIONS: Receipt of care within a medical home was lacking for nearly one-half of preterm toddlers, especially those with lower socioeconomic status and poorer developmental status. Discharge from a neonatal intensive care unit may be an optimal time to facilitate access to a primary care medical home and establish continuity of care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01576783.

Effect of Docosahexaenoic Acid Supplementation vs Placebo on Developmental Outcomes of Toddlers Born Preterm: A Randomized Clinical Trial.

Importance: Intake of dietary docosahexaenoic acid (DHA) among toddlers is low. Supplementation may benefit developmental outcomes of toddlers who were born preterm. Objective: To determine whether 6 months of daily DHA supplementation improves developmental outcomes of toddlers who were born preterm. Design, Setting, and Participants: A randomized, fully masked, placebo-controlled trial was conducted from April 26, 2012, to March 24, 2017, at a large US pediatric academic center with 9 neonatal intensive care units. Children born at less than 35 weeks' gestation who were 10 to 16 months corrected age underwent 6 months of intervention. Of 2363 children assessed, 982 were eligible, 605 declined, and 377 enrolled and were randomized. Analyses were according to intent to treat. Interventions: One-to-one allocation to receive daily microencapsulated DHA, 200 mg, and arachidonic acid (AA), 200 mg (DHA+AA), or microencapsulated corn oil (placebo). Main Outcomes and Measures: The primary outcome specified a priori was Bayley Scales of Infant and Toddler Development, third edition (Bayley-III), cognitive composite score at 16 to 22 months corrected age. Secondary outcomes were Bayley-III language and motor composite scores and Infant Behavior Questionnaire-Revised and Early Childhood Behavior Questionnaire effortful control and activity level scores. Subgroup analyses defined a priori were by income, sex, and birth weight. Results: Among 377 children randomized and included in the analysis (182 girls and 195 boys; median corrected age, 15.7 months), 338 children (89.7%) had complete data on the primary outcome. Bayley-III cognitive scores did not differ between the DHA+AA and placebo groups (difference in change, 0.5 [95% CI, -1.8 to 2.8]; effect size, 0.05; P = .66). Assignment to the DHA+AA group had a small to medium negative effect on Bayley-III language scores among children with lower birth weights (eg, a child with a birth weight of 1000 g assigned to receive DHA+AA experienced a 4.1-point relative decrease, while a child assigned to placebo did not; P = .03 for interaction). Supplementation had a similar negative effect on effortful control scores among children with annual household incomes greater than $35 000 (difference in change, -0.3 [95% CI, -0.4 to -0.1]; effect size, -0.37; P = .01). Bayley-III motor scores and activity level scores were unaffected. Conclusions and Relevance: Daily supplementation with 200 mg of DHA and 200 mg of AA for 6 months resulted in no improvement in cognitive development and early measures of executive function vs placebo, and may have resulted in negative effects on language development and effortful control in certain subgroups of children. These findings do not support DHA supplementation in the second year of life for children who are born preterm. Trial Registration: ClinicalTrials.gov Identifier: NCT01576783.

Early childhood constraint therapy for sensory/motor impairment in cerebral palsy: a randomised clinical trial protocol.

INTRODUCTION: Cerebral palsy (CP) is the most common physical disability in childhood. It is a disorder resulting from sensory and motor impairments due to perinatal brain injury, with lifetime consequences that range from poor adaptive and social function to communication and emotional disturbances. Infants with CP have a fundamental disadvantage in recovering motor function: they do not receive accurate sensory feedback from their movements, leading to developmental disregard. Constraint-induced movement therapy (CIMT) is one of the few effective neurorehabilitative strategies shown to improve upper extremity motor function in adults and older children with CP, potentially overcoming developmental disregard. METHODS AND ANALYSIS: This study is a randomised controlled trial of children 12-24 months corrected age studying the effectiveness of CIMT combined with motor and sensory-motor interventions. The study population will comprise 72 children with CP and 144 typically developing children for a total of N=216 children. All children with CP, regardless of group allocation will continue with their standard of care occupational and physical therapy throughout the study. The research material collected will be in the form of data from high-density array event-related potential scan, standardised assessment scores and motion analysis scores. ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board. The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT02567630.

Executive functions, social information processing, and social adjustment in young children born with very low birth weight.

Children born with very low birth weight (VLBW) are at risk for neurocognitive and behavioral sequelae. Although VLBW infants are at higher risk for deficits in executive functions (EFs) and social functioning during school-age years, few studies have investigated those sequelae or their association in young children born VLBW. We examined the associations between EFs and social functioning in preterm, VLBW children age 4-6 years (n = 20) and matched, term-born, normal birth weight controls admitted to the neonatal intensive care unit (NICU) after birth (n = 18). The groups did not differ significantly on measures of EFs, social information processing, or parent-reported social adjustment. The VLBW group had lower IQs than controls, though both group means were in the average range. Within the VLBW group, medical predictors of better EFs included older gestational age at birth and no history of bronchopulmonary dysplasia. Across groups, EFs and social information processing were positively correlated. Deficits in EFs and social functioning may emerge after the preschool years in VLBW children, or improved care of children born VLBW may be reducing the cognitive and psychosocial sequelae observed in earlier cohorts. Among children born VLBW, early EFs may be directly related to social information processing.

Pilot study of the efficacy of constraint-induced movement therapy for infants and toddlers with cerebral palsy.

The evidence for Constraint-Induced Movement Therapy (CIMT) effectiveness for infants and toddlers with unilateral cerebral palsy is minimal. We performed a pilot study of CIMT using one-month usual care, one-month intervention, and one-month maintenance (return to usual care) phases on five infants (7- to 18-month old). For the CIMT phase, the infants received 2 hr of occupational therapy and 1 hr of parent-implemented home program for five days/week. The infants were casted for the first 23 days, and bimanual therapy was provided for the last three days. Fine motor skills for the more affected arm and gross motor skills improved significantly during the CIMT; these gains were maintained at one-month follow-up. Individual infant data show mixed effects. This pilot study provides initial evidence that CIMT is feasible for infants with unilateral cerebral palsy, and presents preliminary data for CIMT on fine and gross motor performance.