Infant, Premature, DiseasesSPEEDINCT02153736
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention
A study testing SPEEDI Intervention in people with Infant, Premature, Diseases and Brain White Matter Disease Periventricular, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 weeks
- Conditions the study is for
- Infant, Premature, Diseases, Brain White Matter Disease Periventricular
- What is being tested?
- SPEEDI Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born extremely preterm (˂29 weeks of gestation) OR 10 born preterm and diagnosed with a neonatal brain injury including intraventricular hemorrhage grade 3 or 4, periventricular white matter injury, or hydrocephalus requiring a shunt.
- Medically stable by 40 weeks of gestation, including being off ventilator support
- Live within 50 minutes of the hospital.
- English Speaking mother
- Mother willing and able to participate in the study with the infant subject
Who cannot join
- Genetic syndromes or musculoskeletal deformities
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
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.
Read the detailed description
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.
- Being tested
- SPEEDI Intervention
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPEEDI InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | This group of subjects will receive usual care provided in the medial system and community. |
| SPEEDI Intervention | Experimental | This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development. Receives: Behavioral: SPEEDI Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching (Toy Contact Duration)
Duration the infant is in contact with the target is used to quantify changes in reaching.
Measured: 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.
Measured: End of intervention, 1 and 3 months post intervention
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline to End of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., Children's Hospital Foundation
- Responsible party
- Sponsor
- Investigators
- Stacey C Dusing, PhD PT, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153736
- Sponsor's protocol ID
- HM20001308
- Acronym
- SPEEDI
- Status last verified
- Jan 2018
- First submitted
- 27 May 2014
- Last updated
- 29 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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.
Publications
Dusing SC, Tripathi T, Marcinowski EC, Thacker LR, Brown LF, Hendricks-Munoz KD. Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial. BMC Pediatr. 2018 Feb 9;18(1):46. doi: 10.1186/s12887-018-1011-4.
PubMed 29426320
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
- ClinicalTrials.gov ID
- NCT02153736
- Acronym / sponsor ID
- SPEEDI / HM20001308
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., Children's Hospital Foundation
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 18 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –This group of subjects will receive usual care provided in the medial system and community. |
| SPEEDI Intervention | Experimental | Behavioral: SPEEDI InterventionThis group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development. |
Who may qualify
- Ages
- Up to 18 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- born extremely preterm (˂29 weeks of gestation) OR 10 born preterm and diagnosed with a neonatal brain injury including intraventricular hemorrhage grade 3 or 4, periventricular white matter injury, or hydrocephalus requiring a shunt.
- Medically stable by 40 weeks of gestation, including being off ventilator support
- Live within 50 minutes of the hospital.
- English Speaking mother
- Mother willing and able to participate in the study with the infant subject
Key exclusion criteria (1 listed)
- Genetic syndromes or musculoskeletal deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPEEDI InterventionBehavioral 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. | Behavioural | SPEEDI Intervention |
Primary outcome
Reaching (Toy Contact Duration)
Time frame: 1 month post intervention
Duration the infant is in contact with the target is used to quantify changes in reaching.
Early Problem Solving Indicator (EPSI)
Time frame: End of intervention, 1 and 3 months post intervention
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.
4 secondary outcomes
Early Feeding Skill Assessment (FES)
Time frame: Baseline, End phase 1, End of intervention, 1 and 3 months post intervention
Parent Child Early Relational Assessment (PCERA)
Time frame: Baseline, End phase 1, End of intervention, 1 month post intervention
Bayley Scales of Infant and Toddler Development (Bayley).
Time frame: 3 month post intervention
Test of Infant Motor Performance (TIMP)
Time frame: Baseline to End of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29426320Dusing SC, Tripathi T, Marcinowski EC, Thacker LR, Brown LF, Hendricks-Munoz KD. Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial. BMC Pediatr. 2018 Feb 9;18(1):46. doi: 10.1186/s12887-018-1011-4.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey C Dusing, PhD PT principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPEEDI Intervention in people with Infant, Premature, Diseases and Brain White Matter Disease Periventricular, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaching (Toy Contact Duration) (time frame: 1 month post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02153736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.