Premature BirthNCT00268931
Development Training in Babies Born Preterm
A study testing Movement Training and Social Training in people with Premature Birth, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The specific purpose of this study is to determine the effect of movement training on the onset of motor skills in babies born prematurely. We hypothesize that infants who participate in movement training will show advances in motor skills, visual attention, and toy-oriented behavior. Read more about this study
- Who is it for?
- Ages 6 to 11 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Movement Training and Social Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 11 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born less than 33 weeks gestation (up to and including 32 6/7 weeks)
- Infants born weighing less than 2500 grams
Who cannot join
- Orthopedic, visual or hearing impairments
- Fetal drug exposure
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Systems
Newark, Delaware, 19718
About this study
Official title: Enhanced Developmental Training Experiences in Babies Born Preterm
The specific purpose of this study is to determine the effect of movement training on the onset of motor skills in babies born prematurely. We hypothesize that infants who participate in movement training will show advances in motor skills, visual attention, and toy-oriented behavior.
Read the detailed description
The long term goal of this research program is to develop detailed intervention options for physical therapy treatment of very young preterm infants at risk for disability. The ability of infants to start reaching marks the beginning of an infants' ability to independently explore objects, and impacts development across multiple domains, including cognitive, language, and social. The aim of this study is to determine if bi-daily movement training will advance the reaching abilities of infants born preterm as compared to non-movement trained controls.
Movement Training Group:
Parents/Caregivers will be instructed to improve their infants' awareness and ability to reach for toys with their arms and legs by performing two sets of 10 minutes of daily exercises with them. The first 10 minutes will focus on improving awareness of their arms and toys (such as bells on their wrists). The second 10 minutes of activity that focuses on introducing infants to a task-space they rarely experience at this age, the task-space required for midline reaching (such as moving the infant's arm to a midline toy). An experimenter will visit each family in their homes every other week (the week that is not a testing week) to assure correctness of training, encourage full participation and answer any questions.
Social Training Group:
To control for increased social interaction that accompanies the enhanced training, parents of infants in this group will serve as a control group. Parent/Caregivers will be asked to perform 2x a day of 10 minutes face-to-face social interaction with their infants. Parents and infants will receive a 10 minute audio tape of popular kids' songs. They will be instructed to place infants supine or in a bouncy seat and interact with the infant visually and verbally during this time period along with the music.
After the study is completed, each group will be offered the training booklet that the opposite group received.
- Conditions
- Premature Birth
- Being tested
- Movement Training, Social Training
- Keywords
- premature birth, motor skills, learning, reaching
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement TrainingBehavioural
This group of infants underwent specific movement training activities two times per day with their parents.
Social TrainingBehavioural
This group underwent special social interactions with their parents two times each day.
| Study group | Role | What they receive |
|---|---|---|
| True Control | No intervention | This group is being enrolled as a true control group. This group will not participate in the movement training or social training however, they will be evaluated in the same way. |
| Social Training | Experimental | This group underwent specific social interactions two times each day with their parents. Receives: Behavioral: Social Training |
| Movement Training | Experimental | This group of preterm infants underwent movement training two times per day with their parents. Receives: Behavioral: Movement Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to evaluate the effectiveness of movement training in preterm babies. This will be measured by number of toy contacts, hand/foot-toy distance, duration of toy contact, and duration of visual attention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startAug 2004
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Sponsor
- Investigators
- Jill C. Heathcock, MPT, Principal investigator, University of DelawareJames C Galloway, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268931
- Sponsor's protocol ID
- 24098
- Status last verified
- Apr 2013
- First submitted
- 21 Dec 2005
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fagen JW, Morrongiello BA, Rovee-Collier C, Gekoski MJ. Expectancies and memory retrieval in three-month-old infants. Child Dev. 1984 Jun;55(3):936-43.
PubMed 6734328Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The relative kicking frequency of infants born full-term and preterm during learning and short-term and long-term memory periods of the mobile paradigm. Phys Ther. 2005 Jan;85(1):8-18.
PubMed 15623358Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The performance of infants born preterm and full-term in the mobile paradigm: learning and memory. Phys Ther. 2004 Sep;84(9):808-21.
PubMed 15330694Cherkes-Julkowski M. Learning disability, attention-deficit disorder, and language impairment as outcomes of prematurity: a longitudinal descriptive study. J Learn Disabil. 1998 May-Jun;31(3):294-306. doi: 10.1177/002221949803100309.
PubMed 9599962de Vries AM, de Groot L. Transient dystonias revisited: a comparative study of preterm and term children at 2 1/2 years of age. Dev Med Child Neurol. 2002 Jun;44(6):415-21. doi: 10.1017/s0012162201002298.
PubMed 12088310Angulo-Kinzler RM, Ulrich B, Thelen E. Three-month-old infants can select specific leg motor solutions. Motor Control. 2002 Jan;6(1):52-68. doi: 10.1123/mcj.6.1.52.
PubMed 11842270
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Developmental Training Experiences in Babies Born Preterm
- ClinicalTrials.gov ID
- NCT00268931
- Acronym / sponsor ID
- 24098
- Conditions
- Premature Birth
- Keywords
- premature birth, motor skills, learning, reaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- Aug 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific purpose of this study is to determine the effect of movement training on the onset of motor skills in babies born prematurely. We hypothesize that infants who participate in movement training will show advances in motor skills, visual attention, and toy-oriented behavior.
Detailed description
The long term goal of this research program is to develop detailed intervention options for physical therapy treatment of very young preterm infants at risk for disability. The ability of infants to start reaching marks the beginning of an infants' ability to independently explore objects, and impacts development across multiple domains, including cognitive, language, and social. The aim of this study is to determine if bi-daily movement training will advance the reaching abilities of infants born preterm as compared to non-movement trained controls.
Movement Training Group:
Parents/Caregivers will be instructed to improve their infants' awareness and ability to reach for toys with their arms and legs by performing two sets of 10 minutes of daily exercises with them. The first 10 minutes will focus on improving awareness of their arms and toys (such as bells on their wrists). The second 10 minutes of activity that focuses on introducing infants to a task-space they rarely experience at this age, the task-space required for midline reaching (such as moving the infant's arm to a midline toy). An experimenter will visit each family in their homes every other week (the week that is not a testing week) to assure correctness of training, encourage full participation and answer any questions.
Social Training Group:
To control for increased social interaction that accompanies the enhanced training, parents of infants in this group will serve as a control group. Parent/Caregivers will be asked to perform 2x a day of 10 minutes face-to-face social interaction with their infants. Parents and infants will receive a 10 minute audio tape of popular kids' songs. They will be instructed to place infants supine or in a bouncy seat and interact with the infant visually and verbally during this time period along with the music.
After the study is completed, each group will be offered the training booklet that the opposite group received.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True Control | No intervention | –This group is being enrolled as a true control group. This group will not participate in the movement training or social training however, they will be evaluated in the same way. |
| Social Training | Experimental | Behavioral: Social TrainingThis group underwent specific social interactions two times each day with their parents. |
| Movement Training | Experimental | Behavioral: Movement TrainingThis group of preterm infants underwent movement training two times per day with their parents. |
Who may qualify
- Ages
- 6 to 11 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born less than 33 weeks gestation (up to and including 32 6/7 weeks)
- Infants born weighing less than 2500 grams
Key exclusion criteria (2 listed)
- Orthopedic, visual or hearing impairments
- Fetal drug exposure
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 |
|---|---|---|
| Movement TrainingThis group of infants underwent specific movement training activities two times per day with their parents. | Behavioural | Movement Training |
| Social TrainingThis group underwent special social interactions with their parents two times each day. | Behavioural | Social Training |
Primary outcome
The primary outcome is to evaluate the effectiveness of movement training in preterm babies. This will be measured by number of toy contacts, hand/foot-toy distance, duration of toy contact, and duration of visual attention.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Background: PubMed 6734328Fagen JW, Morrongiello BA, Rovee-Collier C, Gekoski MJ. Expectancies and memory retrieval in three-month-old infants. Child Dev. 1984 Jun;55(3):936-43.
- Background: PubMed 15623358Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The relative kicking frequency of infants born full-term and preterm during learning and short-term and long-term memory periods of the mobile paradigm. Phys Ther. 2005 Jan;85(1):8-18.
- Background: PubMed 15330694Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The performance of infants born preterm and full-term in the mobile paradigm: learning and memory. Phys Ther. 2004 Sep;84(9):808-21.
- Background: PubMed 9599962Cherkes-Julkowski M. Learning disability, attention-deficit disorder, and language impairment as outcomes of prematurity: a longitudinal descriptive study. J Learn Disabil. 1998 May-Jun;31(3):294-306. doi: 10.1177/002221949803100309.
- Background: PubMed 12088310de Vries AM, de Groot L. Transient dystonias revisited: a comparative study of preterm and term children at 2 1/2 years of age. Dev Med Child Neurol. 2002 Jun;44(6):415-21. doi: 10.1017/s0012162201002298.
- Background: PubMed 11842270Angulo-Kinzler RM, Ulrich B, Thelen E. Three-month-old infants can select specific leg motor solutions. Motor Control. 2002 Jan;6(1):52-68. doi: 10.1123/mcj.6.1.52.
- University news articleLink provided by the sponsor.
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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.
Jill C. Heathcock, MPT principal investigator
University of Delaware
James C Galloway, Ph.D. 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 Movement Training and Social Training in people with Premature Birth, run by Christiana Care Health Services 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 2 inclusion and 2 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 16 Apr 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is to evaluate the effectiveness of movement training in preterm babies. This will be measured by number of toy contacts, hand/foot-toy distance, duration of toy contact, and duration of visual attention. (time frame: 8 weeks). 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 NCT00268931, which also lists 6 linked publications.
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 16 Apr 2013; AzTrials last refreshed its copy on 27 Oct 2026.