An interventional study of SPEEDI Intervention in Infant, Premature, Diseases and Brain White Matter Disease Periventricular, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged Up to 18 Weeks. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment
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Among 22 studies in Infant, Premature, Diseases with a site in United States — 4 open to participants now, 5 under way, none of them phase 3. Infant, Premature, Diseases · United States.
Among the 22 studies in Infant, Premature, Diseases with a site in United States, this one is the 14th largest by enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2014, is one of 12 with no phase, and was the 8th registered.
88 studies on the registry are indexed under Infant, Premature, Diseases; 11 are open to participants now.
Browse Infant, Premature, Diseases studies →4 of the 22 studies in Infant, Premature, Diseases with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
Loyola University · Sites in United States
Ages 23 wk–32 wk
University of Alabama at Birmingham · Sites in United States
Ages 1 wk–17 wk
Northwest Health · Sites in United States
Ages 23 wk–32 wk
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Infant, Premature, Diseases studies recruiting now, 1 sets no upper age limit and 5 stop at 75 or younger; 6 take children under 18; none take healthy volunteers.
This study: Up to 18 Weeks · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 2
First in 2001; this study’s year is marked. 3 started in 2014.
This study's enrollment of 14 is below the median of 63 across 57 interventional studies indexed under Infant, Premature, Diseases.
Median enrollment 58 across the 16 interventional studies, 55 across the 6 observational. Of the 15 that completed or were terminated, 4 (27%) have results posted.
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None of the 22 has an industry lead sponsor. The 10 most frequent:
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Virginia Commonwealth University has 1 study filed under Infant, Premature, Diseases — fewer than ten, so there is no comparison to draw.
1 of the studies in Infant, Premature, Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06335524University of Alabama at BirminghamInfant-Maternal Partnership and Cognitive Training Study for Preterm Infants | 2026-12 |
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Among the 22 studies in Infant, Premature, Diseases with a site in United States, from their registry updates:
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The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.
The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care. The secondary aim is to assess the efficacy potential of SPEEDI to impact motor and cognitive development as assessed using commonly used clinical outcome measures. The exploratory aims are to assess the impact of SPEEDI on parent child interactions and feeding skills. The findings will provide crucial initial efficacy estimates to be used in a larger definitive clinical trial of SPEEDI.
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Exclusion Criteria:
This group of subjects will receive usual care provided in the medial system and community.
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
Behavioral: SPEEDI Intervention
Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities.
Reaching (Toy Contact Duration)
Duration the infant is in contact with the target is used to quantify changes in reaching.
Time frame: 1 month post intervention
Early Problem Solving Indicator (EPSI)
Problem-solving behaviors were assessed using the Early Problem Solving Indicator (EPSI). The EPSI is the cognitive subtest of the Individual Growth and Development Indicators designed to measure infant and toddler play-based problem-solving through 36 months of age. It defines problem-solving as consisting of visual exploration, object manipulation and memory. The infant was video-recorded interacting with 3 standard toys: pop-up animals toy, 6 seriated, plastic cups, and a gum ball machine with 5 balls. Infants were given each toy for 2 minutes. The frequency of 4 mutually exclusive behaviors (look, explore, function, solution) were coded using definitions from the EPSI protocol. time. The total number of problem solving behaviors was calculated as a sum of look, explore, function, and solution for each infant at each visit and reported as the total EPSI frequency with a higher frequency reflecting more problem solving behaviors.
Time frame: End of intervention, 1 and 3 months post intervention
Early Feeding Skill Assessment (FES)
The Early Feeding Skills (EFS) was used to assess the infant's oral feeding skills during the video recorded feeding described above. The EFS is a 26-item observational tool that can be used from the start of oral feeding through the maturation of feeding skills. Each item can score 1-3 with one representing the least skill or high frequency of problem (an area of clinical concern), and three representing mature skill or absence of problem (area of strength). Subscales included were ability to maintain engagement in feeding, ability to organize oral-motor functioning, ability to coordinate swallowing, and ability to maintain physiological stability. The sum of all the items in a subscale divided by the number of items in the subscale gives the subscale score of 1-3. The sum of all subscales was used to create an EFS total score which could range from 2 to 12 with a higher score reflecting a better feeding performance.
Time frame: Baseline, End phase 1, End of intervention, 1 and 3 months post intervention
Parent Child Early Relational Assessment (PCERA)
The Parent-Child Early Relational Assessment (PCERA; Clark, 2010; Clark, 1999) was designed to assess mother-infant interaction. In this study PCERA was scored from a video of the feeding interaction. The PCERA is a 65-item observational rating scale (29 parental, 27 infant, and 8 dyadic), designed to assess the amount, duration, and intensity of interaction. Each item was rated on a 3-point ordinal scale with 1-2 indicating an area of concern, 3 indicating an area for some concern and 4- 5 indicating an area of strength. Eight subscales constructed from items of the PCERA have been theoretically derived and confirmed by factor analysis (Clark, 1999; Clark et al., 1997). For ease of analysis this scale was transformed to a -1 to +1 range. Scores were recorded as 1 or 2 = -1, 3= 0, 4 or 5 = 1. The total PCERA score is the mean of all the subscale mean scores and ranged -1 (highest risk of atypical interactions) to +1 (most positive interactions).
Time frame: Baseline, End phase 1, End of intervention, 1 month post intervention
Bayley Scales of Infant and Toddler Development (Bayley).
The Bayley-III is a norm references standardized developmental assessment of Motor, Cognitive, and Language skills. Composite scores for each domain have a mean of 100 and a standard deviation of 15. A score of 85-115 is considered average. Higher composite scores represent higher or better performance on that subtest. The Bayley was administered at the final follow-up visit and 3 months after the intervention ended.
Time frame: 3 month post intervention
Test of Infant Motor Performance (TIMP)
The TIMP is a standardized and norm references test of motor control and posture in infants 4 months of age and younger which is commonly used with infants starting at 34 weeks of post-menstrual age. Change in raw score from baseline to end of the intervention is reported. The TIMP raw score ranges from 0 to 142. A higher score represented greater performance in motor control and posture.
Time frame: Baseline to End of intervention
| Milestone | Usual Care Group | SPEEDI Intervention |
|---|---|---|
| Started | 7 | 7 |
| Completed | 5 | 5 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Medical status change made ineligible | 1 | 0 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Duration the infant is in contact with the target is used to quantify changes in reaching.
| Seconds | Usual Care Group | SPEEDI Intervention |
|---|---|---|
| Reaching (Toy Contact Duration) | 20.2 ± 21.45 | 28.02 ± 16.30 |
Problem-solving behaviors were assessed using the Early Problem Solving Indicator (EPSI). The EPSI is the cognitive subtest of the Individual Growth and Development Indicators designed to measure infant and toddler play-based problem-solving through 36 months of age. It defines problem-solving as consisting of visual exploration, object manipulation and memory. The infant was video-recorded interacting with 3 standard toys: pop-up animals toy, 6 seriated, plastic cups, and a gum ball machine with 5 balls. Infants were given each toy for 2 minutes. The frequency of 4 mutually exclusive behaviors (look, explore, function, solution) were coded using definitions from the EPSI protocol. time. The total number of problem solving behaviors was calculated as a sum of look, explore, function, and solution for each infant at each visit and reported as the total EPSI frequency with a higher frequency reflecting more problem solving behaviors.
| # of Problem Solving Behaviors in 6 min | Usual Care Group | SPEEDI Intervention |
|---|---|---|
| End of intervention | 58.00 ± 39.59 | 103.2 ± 28.89 |
| 1 months post intervention | 95.2 ± 52.95 | 131.80 ± 61.44 |
| 3 months post intervention | 146 ± 86.17 | 212 ± 54.98 |
The Early Feeding Skills (EFS) was used to assess the infant's oral feeding skills during the video recorded feeding described above. The EFS is a 26-item observational tool that can be used from the start of oral feeding through the maturation of feeding skills. Each item can score 1-3 with one representing the least skill or high frequency of problem (an area of clinical concern), and three representing mature skill or absence of problem (area of strength). Subscales included were ability to maintain engagement in feeding, ability to organize oral-motor functioning, ability to coordinate swallowing, and ability to maintain physiological stability. The sum of all the items in a subscale divided by the number of items in the subscale gives the subscale score of 1-3. The sum of all subscales was used to create an EFS total score which could range from 2 to 12 with a higher score reflecting a better feeding performance.
| EFS Total score | Usual Care Group | SPEEDI Intervention |
|---|---|---|
| Baseline | 8.32 ± .48 | 8.61 ± 1.44 |
| End phase 1 | 8.27 ± 1.27 | 8.82 ± 1.58 |
| End of intervention Phase 2 | 8.00 ± 0.44 | 9.65 ± 1.17 |
| 1 month post intervention | 10.10 ± 1.36 | 9.91 ± 1.12 |
| 3 months post intervention | 10.00 ± 1.42 | 10.40 ± 1.57 |
The Parent-Child Early Relational Assessment (PCERA; Clark, 2010; Clark, 1999) was designed to assess mother-infant interaction. In this study PCERA was scored from a video of the feeding interaction. The PCERA is a 65-item observational rating scale (29 parental, 27 infant, and 8 dyadic), designed to assess the amount, duration, and intensity of interaction. Each item was rated on a 3-point ordinal scale with 1-2 indicating an area of concern, 3 indicating an area for some concern and 4- 5 indicating an area of strength. Eight subscales constructed from items of the PCERA have been theoretically derived and confirmed by factor analysis (Clark, 1999; Clark et al., 1997). For ease of analysis this scale was transformed to a -1 to +1 range. Scores were recorded as 1 or 2 = -1, 3= 0, 4 or 5 = 1. The total PCERA score is the mean of all the subscale mean scores and ranged -1 (highest risk of atypical interactions) to +1 (most positive interactions).
| Mean Score on PCERA | Usual Care Group | SPEEDI Intervention |
|---|---|---|
| Baseline | 0.27 ± 0.17 | 0.13 ± 0.29 |
| End phase 1 | 0.20 ± 0.30 | 0.38 ± 0.33 |
| End of intervention Phase 2 | 0.34 ± 0.24 | 0.25 ± 0.23 |
| 1 months post intervention | 0.50 ± 0.51 | 0.26 ± 0.25 |
The Bayley-III is a norm references standardized developmental assessment of Motor, Cognitive, and Language skills. Composite scores for each domain have a mean of 100 and a standard deviation of 15. A score of 85-115 is considered average. Higher composite scores represent higher or better performance on that subtest. The Bayley was administered at the final follow-up visit and 3 months after the intervention ended.
| Mean Composite Score on Bayley | Usual Care Group | SPEEDI Intervention |
|---|---|---|
| Motor 3 months post intervention | 79.6 ± 20.8 | 98.6 ± 11.4 |
| Cognitive 3 months post intervention | 80.0 ± 13.5 | 91.0 ± 8.9 |
| Language 3 months post intervention | 89.0 ± 19.6 | 98.2 ± 9.6 |
The TIMP is a standardized and norm references test of motor control and posture in infants 4 months of age and younger which is commonly used with infants starting at 34 weeks of post-menstrual age. Change in raw score from baseline to end of the intervention is reported. The TIMP raw score ranges from 0 to 142. A higher score represented greater performance in motor control and posture.
| Raw Score on the TIMP | Usual Care Group | SPEEDI Intervention |
|---|---|---|
| Baseline | 54 (37 to 60) | 61 (56 to 63) |
| End of Intervention | 82 (72 to 95) | 99 (97 to 118) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care Group | — | 0/7 (0%) | 0/7 (0%) |
| SPEEDI Intervention | — | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(Weeks of post menstrual age) | Usual Care Group | SPEEDI Intervention | Total |
|---|---|---|---|
| Median | 35 (35 to 39) | 39 (36 to 40) | 38 (35 to 39) |
| Sex: Female, Male(Participants) | Usual Care Group | SPEEDI Intervention | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care Group | SPEEDI Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 6 | 7 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Care Group | SPEEDI Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Usual Care Group | SPEEDI Intervention | Total |
|---|---|---|---|
| United States | 7 | 7 | 14 |
| Gestational age(weeks of gestation) | Usual Care Group | SPEEDI Intervention | Total |
|---|---|---|---|
| Median | 26 (25 to 28) | 25 (24 to 27) | 25.5 (25 to 27) |
| Brain Injury (GIII/IV intraventricular hemorrhage , Periventricular leukomalacia, Hypoxic Ischemic E(Participants) | Usual Care Group | SPEEDI Intervention | Total |
|---|---|---|---|
| Count of participants | 2 | 2 | 4 |
Plan to share: No — Given the small sample from a specific time range the data will not be shared due to difficulty de-identifying with demographics of individual infants attached.
The record gives a start of Apr 2014, a primary completion of Oct 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2017, 11 months after primary completion.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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