Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268931
Status:
COMPLETED
Last Update Posted:
2013-04-16
First Post:
2005-12-21
Brief Title:
Development Training in Babies Born Preterm
Sponsor:
Christiana Care Health Services
Organization:
Christiana Care Health Services
Study Overview
Official Title:
Enhanced Developmental Training Experiences in Babies Born Preterm
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
ParentsCaregivers 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 infants 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 ParentCaregivers 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
Movement Training Group
ParentsCaregivers 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 infants 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 ParentCaregivers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None