RESUMO
This study aimed to document the safety and efficacy of a single infusion of autologous umbilical cord blood (UCB) in 20 autistic children aged 24-72 months. A pre-post treatment within-subjects open label design was used. At T = 0, 6, 12, and 18 months, participants underwent detailed and structured safety evaluations (via caregiver report), Vineland Adaptive Behavior Scale (Vineland-3), Stanford Binet Intelligence Scale (SB-5), Expressive One-Word Picture Vocabulary Test, Brief Observation of Social Communication Change (BOSCC), Pervasive Developmental Disorder-Behavior Inventory, Repetitive Behavior Scale-Revised, Sensory Experience Questionnaire (SEQ-2.1), Child Behavior Checklist, Clinical Global Impression-Severity and Improvement (CGI-I) Scales, and eye-gaze tracking. UCB infusion was conducted at T = 6 months, hence, 0-6 months was the control period, and 6-18 months the follow-up period. Of 20 children recruited, 19 completed the study and 1 was withdrawn due to UCB not meeting quality control criteria for infusion. There were 15 males and 4 females with an overall mean (SD) age of 4.15 (0.62) years. Mean (SD) cell dose administered was 38.16 (9.82) million cells/kg. None suffered serious adverse events although there were mild behavioral side effects and one unit grew coagulase negative staphylococcus from a post-thaw sample. There were no significant differences in Vineland-3, SB-5, BOSCC, and SEQ-2.1 scores at T = 12 and T = 18 months. Twelve participants had T = 18 CGI-I scores of 2-3 (minimally to much improved), seven participants had scores of 4 (no change). Autologous UCB infusion in autistic children is generally safe but not without risks, including that of infection. In this within-subjects study, some children showed global symptom improvements while others showed no change. Stem cell therapies for autism should only be conducted under strict clinical trial conditions with clear risk discussions.
RESUMO
OBJECTIVE: Despite evidence that excessive screen use may contribute to negative health, developmental, emotional, and behavioral outcomes, more children are engaging in increasing amounts of screen-related activities. For children with neurodevelopmental conditions, increased screen use could exacerbate emotional/behavioral difficulties (EBDs) by interfering with sleep quantity and quality. AIMS: This study examined the possible mediating role of sleep in the relationship between screen use and EBDs in preschool children with neurodevelopmental disorders (NDDs) clinically referred to a child development center in Singapore. METHODS: A screen use questionnaire developed for the purposes of the present study, the Children's Sleep Habits Questionnaire, and the Strengths and Difficulties Questionnaire were completed by 367 caregivers of 2- to 5-year-old children with NDDs (39.5% autism spectrum disorder; 36.8% speech-language disorders; 23.7% others). RESULTS: Average daily screen use duration was 3.98 hours, with 93.9% exceeding 1 hour of screen time daily. 57.7% of children had screen devices in their bedrooms, while 52% commenced screen use at the age of 18 months or earlier. Sleep problems fully mediated the relationship between the number of bedroom screen devices and children's EBDs, as well as between the age of first screen use and EBDs, but not between hours of screen use and EBDs. Controlling for age, developmental level, and family income, children who started using screens earlier than 18 months and who had screen devices in their bedrooms had significantly more sleep problems and EBDs than those without. CONCLUSION: Children with neurodevelopmental conditions may have more difficulties disengaging from screen devices in their bedrooms, and an earlier age of screen exposure may contribute to more chronic disruption of sleep.