Sustainable Model of Early Intervention and Telerehabilitation for Children With Cerebral Palsy in Rural Bangladesh: The SMART-CP Randomized Clinical Trial.
Journal: JAMA pediatrics
Year: April 07, 2025
Access to early intervention and rehabilitation services among children with cerebral palsy (CP) remains limited in Bangladesh, which demands an innovative and sustainable service delivery model. To evaluate the effectiveness of the Sustainable Model of Early Intervention and Telerehabilitation for Children With CP (SMART-CP) model compared with usual care in improving access to and utilization of early diagnosis, early intervention, and rehabilitation services in rural Bangladesh. This was a 2-arm cluster randomized clinical trial, with 8 clusters (ie, subdistricts) randomly allocated to the intervention (SMART-CP model) or control arm. The setting was in Sirajganj, Bangladesh, and included children with CP 18 years or younger. Outcomes were measured at 0 and 12 months, and an intention-to-treat analysis was conducted. Data were analyzed from December 2023 to May 2024. The SMART-CP model comprised (1) a rural referral network involving key informants and caregiver peer groups (called mPower or mothers' power), (2) subdistrict level SMART-CP centers, and (3) telerehabilitation services. Children in the intervention arm received weekly goal-directed therapy, mPower group meetings every 2 weeks, and monthly telerehabilitation sessions. The primary outcome was whether a child with CP accessed any form of rehabilitation services, with secondary outcomes analyzed as hypothesis generating. Overall, 968 children with CP (mean [SD] age, 7.9 [4.9] years; 581 male [60.0%]) were enrolled, with 500 in the intervention arm and 468 in the control arm. Between baseline and endline, rehabilitation services uptake significantly increased in the intervention arm (70.2% [351 of 500] vs 99.4% [497 of 500]), compared with the control arm (63.9% [299 of 468] vs 68.2% [319 of 468]; P <.001). Children in the intervention arm were 1.5 times more likely to access rehabilitation than the control arm. Secondary analyses suggested that the intervention arm also facilitated early CP diagnosis (mean [SD] diagnosis time, 2.0 [2.0] years vs 3.8 [3.3] years; Cohen d = -0.7) and initiation of rehabilitation (mean [SD] rehabilitation time, 1.8 [1.8] years vs 3.6 [2.4] years; Cohen d = -0.9). Additionally, higher therapy session counts (mean [SD] session counts, 23.4 [31.7] vs 4.3 [20.8]; Cohen d = 0.7), increased assistive device utilization (20.8% [104 of 500] vs 3.0% [14 of 468]; risk ratio, 0.82; 95% CI, 0.78-0.86; P < .001), and lower out-of-pocket expenditure per month (mean [SD] expenditure, $1.5 [$1.6] vs $2.9 [$5.1]; Cohen d = -0.4) were found in the intervention arm. No significant difference in clinical outcomes and mortality rates was observed between the intervention and control groups. Results of this cluster randomized clinical trial reveal that the SMART-CP model improved access to and utilization of early diagnosis and intervention services for children with CP in rural Bangladesh. This model holds promise for global scalability. ANZCTR Trial Identifier: ACTRN12622000396729.
How a Microfinance-Based Livelihood Program can Combat Food Insecurity Among Families of Children With Cerebral Palsy in Bangladesh-Evidence From a Randomized Control Trial.
Journal: Food And Nutrition Bulletin
Year: June 19, 2025
BackgroundHousehold food insecurity is a critical concern for ultra-poor families in low- and middle-income countries like Bangladesh, particularly those with members who have disabilities. The COVID-19 pandemic has worsened this situation.ObjectiveThis study aimed to assess the impact of microfinance-based livelihood programs on food insecurity in ultra-poor families with members affected by cerebral palsy in Bangladesh.MethodsData were extracted from the SUPPORT CP trial for 251 children with cerebral palsy. The Household Food Insecurity Access Scale score was the outcome variable. The explanatory variable was the intervention type, dividing the sample into 3 arms: Arm C (care as usual), Arm B (Community-Based Rehabilitation [CBR]), and Arm A (CBR with the integrated microfinance-based livelihood program [IMCBR]). Both linear regression and the Generalized Estimating Equations model were used to determine the association of outcome variable with explanatory variables adjusting for covariates.ResultsWe found a consistent level of household food insecurity across each time point, with a significant increase in the midline during the peak of COVID-19 pandemic in 2020. However, following the end of the COVID-19 pandemic, both Arms A and B, where interventions were provided, reported a significant decline in food insecurity. Notably, Arm A, where IMCBR was provided, exhibited the fastest decrease in food insecurity followed by Arm B, where only CBR was provided, compared to Arm C.ConclusionMicrofinance programs can reduce food insecurity among families of children with cerebral palsy in Bangladesh, especially during crises like COVID-19, underscoring the need to integrate them with tailored disability rehabilitation services.
Intrapartum Sildenafil to Improve Perinatal Outcomes: A Randomized Clinical Trial.
Journal: Jama
Year: June 09, 2025
Sildenafil citrate may increase uteroplacental blood flow. Its ability to reduce perinatal complications related to fetal hypoxia during labor is uncertain. To compare the effectiveness of intrapartum maternal oral sildenafil citrate vs placebo in improving perinatal outcomes potentially related to intrapartum hypoxia in term pregnancies. This pragmatic, multicenter, investigator-initiated, placebo-controlled randomized clinical trial including 3257 women was conducted in 13 Australian hospitals from September 6, 2021, to June 28, 2024. The last date of follow-up (28-day neonatal mortality) was July 26, 2024. Women aged 18 years or older with singleton or dichorionic twin pregnancies, planning vaginal birth at term by either spontaneous labor or induction of labor, were recruited. Women were assigned to 50 mg oral sildenafil citrate every 8 hours up to 150 mg or equivalent placebo. The primary composite outcome was intrapartum stillbirth, neonatal death, Apgar score less than 4 at 5 minutes (a score of <4 at 5 minutes is indicative of severe neonatal depression at birth, with scores ranging from 0 to 10), acidosis at birth (umbilical cord artery pH <7.0), hypoxic ischemic encephalopathy, neonatal seizures, neonatal respiratory support for greater than 4 hours, neonatal unit admission for greater than 48 hours, persistent pulmonary hypertension of the newborn, or meconium aspiration syndrome. Secondary outcomes were the individual components of the primary composite and emergency cesarean delivery or instrumental birth for intrapartum fetal distress. A total of 3257 women were randomized to sildenafil citrate (n = 1626 women and 1634 infants) or placebo (n = 1631 women and 1641 infants). Mean (SD) maternal age and gestation at randomization were similar in both groups (31.7 [5.1] vs 31.5 [5.0] years and 39.5 [1.2] vs 39.5 [1.1] weeks, respectively). A total of 868 participants (53.4%) vs 874 participants (53.6%) were of Australia/New Zealand ethnicity and 315 participants (19.4%) vs 311 participants (19.1%) were of European ethnicity. Most participants were nulliparous (944 of 1624 [58.1%; 2 missing values] vs 966 of 1630 [59.3%; 1 missing value]). Induction of labor occurred in 1353 of 1621 women (83.5%) in the sildenafil citrate group and 1348 of 1627 women (82.9%) in the placebo group. The primary outcome occurred in 83 of 1625 women (5.1%) in the sildenafil citrate group and 84 of 1625 (5.2%) in the placebo group (relative risk, 1.02; 95% CI, 0.75-1.37). Sildenafil citrate had no significant effect on emergency cesarean delivery or instrumental vaginal birth for fetal distress (relative risk, 1.12; 95% CI, 0.98-1.29) or on any of the individual components of the primary outcome. Subgroup analyses showed no evidence of heterogeneity of treatment effect. Sildenafil citrate did not result in a lower incidence of adverse perinatal outcomes potentially related to intrapartum hypoxia. anzctr.org.au Identifier: ACTRN12621000231842.
Towards universal early screening for cerebral palsy: a roadmap for automated General Movements Assessment.
Journal: EClinicalMedicine
Year: April 16, 2025
Cerebral palsy (CP) is the most common lifelong physical disability, affecting millions globally. Early detection and intervention are crucial for improving outcomes, yet many children are diagnosed late. The General Movements Assessment (GMA) is a highly accurate clinical tool for detecting infants at high probability of CP, but access to health professionals trained in the GMA limits its use. Artificial intelligence (AI) has the potential to automate the GMA, increasing accessibility worldwide. We established an interdisciplinary, international consortium for the purpose of developing a roadmap for the ongoing development and implementation of an AI-enabled GMA system for universal CP screening worldwide. The consortium included clinicians (children neurologists, paediatricians, neonatologists, allied health), researchers, engineers, computer scientists, legal experts, and individuals with lived experience, from around the globe (across Africa, Australia, Europe, and North America). The roadmap identifies the following steps and key requirements within: (1) development of standards for AI validation; (2) development of AI-GMA from large and diverse validation sets; (3) development of software tools and clinical pathways; (4) regulatory requisites; and (5) implementation. With the roadmap, AI-enabled screening for CP incorporating state-of-the-art technology can be made possible. Future work will require international collaboration to allow for scaling of data sets, refining automated solutions and translation into practice. Cerebral Palsy Foundation, Cerebral Palsy Alliance, European Union Born to Get There, the National Health and Medical Research Council.
Health literacy of primary caregivers of children with cerebral palsy in low- and middle-income countries: a systematic review.
Journal: BMJ Open
Year: March 03, 2025
Objective: We aimed to synthesise existing literature on the health literacy of primary caregivers (PCGs) of children with cerebral palsy (CP) in low- and middle-income countries (LMICs).
Methods: Systematic review informed by Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Methods: Ovid MEDLINE, Ovid EMBASE, CINAHL via EBSCO, Scopus and Web of Science were searched from inception to January 2024. Methods: Original studies including observational or experimental data, examining health literacy and/or health literacy proxies using Optimising Health Literacy and Access domains as indicators (eg, education, social support, self-efficacy, health attitudes, reading and writing skills) in primary caregivers of children with CP in LMICs. Methods: Data from included studies were systematically recorded using an Excel template, with information extracted independently by two reviewers. We used the Study Quality Assessment Tool developed by the National Health, Lung, and Blood Institute.
Results: The systematic review yielded 2734 articles, with 15 eligible for inclusion. None used health literacy (HL) measurement tools, and there was limited reporting on specific HL domains. Studies spanned 11 LMICs across 5 major regions. PCGs, predominantly mothers, exhibited varying levels of service awareness, service utilisation and social support. Literacy levels significantly impacted HL proficiency, exposing a notable research gap in LMICs.
Conclusions: This study presents the first comprehensive analysis of health literacy among PCGs of children with CP in LMICs. Findings reveal a striking absence of tailored health literacy literature, impacting current considerations of PCGs' understanding and management of their child's condition. Additionally, challenges in social support, healthcare navigation and low literacy levels further hinder effective caregiving in LMICs.