Clinical Trials Directory

Trials / Completed

CompletedNCT00268931

Development Training in Babies Born Preterm

Enhanced Developmental Training Experiences in Babies Born Preterm

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Christiana Care Health Services · Academic / Other
Sex
All
Age
6 Weeks – 11 Weeks
Healthy volunteers
Not accepted

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: 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

Interventions

TypeNameDescription
BEHAVIORALMovement TrainingThis group of infants underwent specific movement training activities two times per day with their parents.
BEHAVIORALSocial TrainingThis group underwent special social interactions with their parents two times each day.

Timeline

Start date
2004-08-01
Primary completion
2008-04-01
Completion
2008-04-01
First posted
2005-12-23
Last updated
2013-04-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00268931. Inclusion in this directory is not an endorsement.