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Clinical Trials/NCT00268931
NCT00268931
Completed
N/A

Enhanced Developmental Training Experiences in Babies Born Preterm

Christiana Care Health Services1 site in 1 country32 target enrollmentAugust 2004
ConditionsPremature Birth

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Christiana Care Health Services
Enrollment
32
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
13 years ago

Overview

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: 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.

Registry
clinicaltrials.gov
Start Date
August 2004
End Date
April 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Infants born less than 33 weeks gestation (up to and including 32 6/7 weeks)
  • Infants born weighing less than 2500 grams

Exclusion Criteria

  • Orthopedic, visual or hearing impairments
  • Fetal drug exposure

Outcomes

Primary Outcomes

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

Study Sites (1)

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