Development Training in Babies Born Preterm
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Enhanced Developmental Training Experiences in Babies Born Preterm|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
No Intervention: True Control
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.
Experimental: Social Training
This group underwent specific social interactions two times each day with their parents.
Behavioral: Social Training
This group underwent special social interactions with their parents two times each day.
Experimental: Movement Training
This group of preterm infants underwent movement training two times per day with their parents.
Behavioral: Movement Training
This group of infants underwent specific movement training activities two times per day with their parents.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268931
|United States, Delaware|
|Christiana Care Health Systems|
|Newark, Delaware, United States, 19718|
|Principal Investigator:||Jill C. Heathcock, MPT||University of Delaware|
|Principal Investigator:||James C Galloway, Ph.D.||University of Delaware|