Umbilical Cord Blood Therapy for Children With Global Developmental Delay

Keywords

• Global developmental delay
• Umbilical cord blood
• Rehabilitation

Lead sponsor

MinYoung Kim, M.D. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Umbilical Cord Blood and Rehabilitation

  Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation

  Biological: Umbilical Cord Blood administration · Other: Active Rehabilitation

Interventions

• BiologicalUmbilical Cord Blood administration

  The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

  Also known as: Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank

• OtherActive Rehabilitation

  All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.

Primary outcomes

1. Changes in Cognition

   Korean Wechsler Preschool and Primay Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best). The investigators will report K-WPPSI at each assessment time points.

   Time frame: Baseline - 6 months - 12 months

2. Changes in Cognitive Neurodevelopmental Outcome

   Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (Higher value means better cognitive function, K-BSID-II mental scale raw score: 0 - worst, 178 - best). The investigators will report K-BSID-II Mental Scale raw scores at each assessment time points.

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

Secondary outcomes

1. Changes in Motor Performance

   GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\~100, Higher value means better motor quality). The investigators will report GMPM scores at each assessment time points.

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

2. Changes in Standardized Gross Motor Function

   GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0\~100 , Higher value means better gross motor function). The investigators will report GMFM scores at each assessment time points.

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

3. Changes in Motor Neurodevelopmental Outcome

   Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). The investigators will report K-BSID-II Motor Scale raw scores at each assessment time points.

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

4. Changes in Functional Independence in Daily Activities

   WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. The investigators will report total WeeFIM scores measured at each assessment time points.

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

5. Changes in Visual Perception Test

   We will evaluate visual perception function with one of three measures: DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration, Visual Perception and Motor Coordination). All can be scored as percentile rank from 0 to 100. Higher values mean better visual perception ability

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

6. Changes in Muscle Strength

   Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 \~ 160) Higher scores mean better muscle strength. Categories of outcome table will be summation of MMT scores measured at each assessment time point.

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

7. Changes in Functional Performance in Daily Activities

   Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We will report 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table will be each domain scores measured at each assessment time point.

   Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

8. Changes in Language Evaluation

   Sequenced Language Scale for Infant (SELSI), Preschool Receptive-Expressive Language Scale (PRES) or Korean Western Aphasia Battery (K-WAB) will be used depending on age and function.

   Time frame: Baseline - 6 months - 12 months