Preterm InfantNCT04266717
A Novel Parent Education Program for Early Intervention
A study testing Baby Play Intervention and Milestone Education in people with Preterm Infant and Full-term Infant, run by University of Delaware at 1 site in United States.
Trial summary
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive… Read more about this study
- Who is it for?
- Ages 1 month to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Full-term Infant
- What is being tested?
- Baby Play Intervention and Milestone Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 30 Jun 2020
- 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 1 month to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant meeting the age criteria
- Access to the internet
- Residence within driving distance of the University of Delaware
- Parental ability to read and communicate in English
Who cannot join
- Genetic diagnosis
- Progressive diagnosis such as spinal muscular atrophy
- Medical or movement restrictions that would interfere with participation in the study activities
Trial locations and contacts
1 site in 1 country.
About this study
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. This project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.
Read the detailed description
One in 10 children in the United States is born preterm and at risk for disabilities that can impair movement and cognition. Research suggests that targeted early intervention can effectively improve ability and function for these children. However, two key obstacles limit the provision of early intervention services in the first half-year of life. First, the existing diagnostic tools are limited in their ability to identify motor and cognitive delays at early ages. Second, in the medical model there is a lack of understanding of developmental science and how experiences in the first months of life can impact the development of future abilities. In effect, there has been lack of knowledge regarding who should receive early intervention services and what activities should be the focus of those services in infancy.
This project aims to address these challenges by testing the fidelity and short-term efficacy of a novel intervention providing education for parents of preterm infants. The intervention will educate parents on ways to handle, position, and play with their infants to provide infants safe opportunities to explore new ways of moving and controlling their bodies and interacting with objects. Intervention provision will be documented and outcomes will be compared for 20 infants randomized to receive one of two types of developmental education. Pre- and post-assessments will compare motor control in prone, reaching ability, daily positioning practices, and parent-child interactions with toys to determine if there are differences in the short-term effects of the intervention. Intervention will occur for two months with parents logging activity daily. Measures related to dosage and how parents perform the intervention activities will be gathered to assess fidelity of the intervention.
Aim 1: To measure aspects related to fidelity for families participating in the study.
Aim 2: To determine if there is a difference in developmental outcomes for children who receive the intervention.
- Conditions
- Preterm Infant, Full-term Infant
- Being tested
- Baby Play Intervention, Milestone Education
- Keywords
- development, infant, preterm, parent education, play, full-term
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Play InterventionBehavioural
Baby Play Intervention involves teaching parents targeted ways they can handle, position, and play with young infants that aim to provide infants enhanced early opportunities to learn to control their bodies and interact with objects. These abilities are associated with future motor, cognitive, and language outcomes. Parents will be asked to perform the intervention activities 20 minutes daily and to log their activity performance weekly.
Milestone EducationBehavioural
Parents in the Milestone Education Intervention group will receive information regarding milestones expected based on infants' CA. This information is based on forms from the Centers for Disease Control and Prevention (CDC) and The American Academy of Pediatrics (AAP). This will help parents understand the milestones typically observed at the their child's CA and reflects the education parents receive from healthcare providers. Parents will be asked to provide their infants opportunities to perform these milestone behaviors 20 minutes daily and to log their activity performance weekly.
| Study group | Role | What they receive |
|---|---|---|
| Baby Play Parent Education Group | Experimental | Baby Play Intervention involves teaching parents targeted ways they can handle, position, and play with young infants that aim to provide infants enhanced early opportunities to learn to control their bodies and interact with objects. These abilities are associated with future motor, cognitive, and language outcomes. Parents will be asked to perform the intervention activities 20 minutes daily and to log their activity performance weekly. Receives: Behavioral: Baby Play Intervention |
| Milestone Education Group | Active comparator | Parents in the Milestone Education Intervention group will receive information regarding milestones expected based on infants' CA. This information is based on forms from the Centers for Disease Control and Prevention (CDC) and The American Academy of Pediatrics (AAP). This will help parents understand the milestones typically observed at the their child's CA and reflects the education parents receive from healthcare providers. Parents will be asked to provide their infants opportunities to perform these milestone behaviors 20 minutes daily and to log their activity performance weekly. Receives: Behavioral: Milestone Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alberta Infant Motor Scale - Change in Total Percentile Score
We will assess infants using the AIMS, a valid and reliable developmental assessment for 0-18-month-olds. It consists of observation of weight bearing, posture, and antigravity movement in supine, prone, sitting, and standing subscales. Infants will receive scores for each subscale (secondary outcomes) that are summer for a total sum score that will be converted to percentile rank (ranging from 0-100). The change in percentile rank from baseline through 1 month will serve as the primary outcome measure for this study to compare the effects of the two interventions with a higher value representing a greater change and the sign representing the direction of change (i.e., positive means developmental performance improved). The AIMS will be used because the PI has shown it to be a sensitive measure of change for FT infants whose parents received handling and positioning education.
Measured: at baseline and 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start17 Jan 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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.
- Other trials for Preterm InfantStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Michele Lobo, University of Delaware
- Investigators
- Michele A Lobo, PT, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266717
- Sponsor's protocol ID
- PHYT32228419000
- Other IDs
- 2U54GM104941-06
- Status last verified
- Sep 2023
- First submitted
- 8 Oct 2019
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This small data set will serve as pilot data for future grant applications.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Parent Education Program for Early Intervention
- ClinicalTrials.gov ID
- NCT04266717
- Acronym / sponsor ID
- PHYT32228419000
- Conditions
- Preterm Infant, Full-term Infant
- Keywords
- development, infant, preterm, parent education, play, full-term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Christiana Care Health Services, National Institute of General Medical Sciences (NIGMS)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 31 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. This project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.
Detailed description
One in 10 children in the United States is born preterm and at risk for disabilities that can impair movement and cognition. Research suggests that targeted early intervention can effectively improve ability and function for these children. However, two key obstacles limit the provision of early intervention services in the first half-year of life. First, the existing diagnostic tools are limited in their ability to identify motor and cognitive delays at early ages. Second, in the medical model there is a lack of understanding of developmental science and how experiences in the first months of life can impact the development of future abilities. In effect, there has been lack of knowledge regarding who should receive early intervention services and what activities should be the focus of those services in infancy.
This project aims to address these challenges by testing the fidelity and short-term efficacy of a novel intervention providing education for parents of preterm infants. The intervention will educate parents on ways to handle, position, and play with their infants to provide infants safe opportunities to explore new ways of moving and controlling their bodies and interacting with objects. Intervention provision will be documented and outcomes will be compared for 20 infants randomized to receive one of two types of developmental education. Pre- and post-assessments will compare motor control in prone, reaching ability, daily positioning practices, and parent-child interactions with toys to determine if there are differences in the short-term effects of the intervention. Intervention will occur for two months with parents logging activity daily. Measures related to dosage and how parents perform the intervention activities will be gathered to assess fidelity of the intervention.
Aim 1: To measure aspects related to fidelity for families participating in the study.
Aim 2: To determine if there is a difference in developmental outcomes for children who receive the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baby Play Parent Education Group | Experimental | Behavioral: Baby Play InterventionBaby Play Intervention involves teaching parents targeted ways they can handle, position, and play with young infants that aim to provide infants enhanced early opportunities to learn to control their bodies and interact with objects. These abilities are associated with future motor, cognitive, and language outcomes. Parents will be asked to perform the intervention activities 20 minutes daily and to log their activity performance weekly. |
| Milestone Education Group | Active comparator | Behavioral: Milestone EducationParents in the Milestone Education Intervention group will receive information regarding milestones expected based on infants' CA. This information is based on forms from the Centers for Disease Control and Prevention (CDC) and The American Academy of Pediatrics (AAP). This will help parents understand the milestones typically observed at the their child's CA and reflects the education parents receive from healthcare providers. Parents will be asked to provide their infants opportunities to perform these milestone behaviors 20 minutes daily and to log their activity performance weekly. |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant meeting the age criteria
- Access to the internet
- Residence within driving distance of the University of Delaware
- Parental ability to read and communicate in English
Key exclusion criteria (3 listed)
- Genetic diagnosis
- Progressive diagnosis such as spinal muscular atrophy
- Medical or movement restrictions that would interfere with participation in the study activities
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 |
|---|---|---|
| Baby Play InterventionBaby Play Intervention involves teaching parents targeted ways they can handle, position, and play with young infants that aim to provide infants enhanced early opportunities to learn to control their bodies and interact with objects. These abilities are associated with future motor, cognitive, and language outcomes. Parents will be asked to perform the intervention activities 20 minutes daily and to log their activity performance weekly. | Behavioural | Baby Play Parent Education Group |
| Milestone EducationParents in the Milestone Education Intervention group will receive information regarding milestones expected based on infants' CA. This information is based on forms from the Centers for Disease Control and Prevention (CDC) and The American Academy of Pediatrics (AAP). This will help parents understand the milestones typically observed at the their child's CA and reflects the education parents receive from healthcare providers. Parents will be asked to provide their infants opportunities to perform these milestone behaviors 20 minutes daily and to log their activity performance weekly. | Behavioural | Milestone Education Group |
Primary outcome
Alberta Infant Motor Scale - Change in Total Percentile Score
Time frame: at baseline and 1 month later
We will assess infants using the AIMS, a valid and reliable developmental assessment for 0-18-month-olds. It consists of observation of weight bearing, posture, and antigravity movement in supine, prone, sitting, and standing subscales. Infants will receive scores for each subscale (secondary outcomes) that are summer for a total sum score that will be converted to percentile rank (ranging from 0-100). The change in percentile rank from baseline through 1 month will serve as the primary outcome measure for this study to compare the effects of the two interventions with a higher value representing a greater change and the sign representing the direction of change (i.e., positive means developmental performance improved). The AIMS will be used because the PI has shown it to be a sensitive measure of change for FT infants whose parents received handling and positioning education.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This small data set will serve as pilot data for future grant applications.
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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.
Michele A Lobo, PT, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Play Intervention and Milestone Education in people with Preterm Infant and Full-term Infant, run by University of Delaware 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 4 inclusion and 3 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 21 Sep 2023. 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 31 Oct 2022). 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?
Alberta Infant Motor Scale - Change in Total Percentile Score (time frame: at baseline and 1 month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.