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Development Training in Babies Born Preterm

This study has been completed.
Sponsor:
Collaborator:
University of Delaware
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00268931
First received: December 21, 2005
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Premature Birth
Behavioral: Movement Training
Behavioral: Social Training

Study Type: Interventional
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

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: August 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 11 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268931

Locations
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
University of Delaware
Investigators
Principal Investigator: Jill C. Heathcock, MPT University of Delaware
Principal Investigator: James C Galloway, Ph.D. University of Delaware
  More Information

Additional Information:
Publications:
Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00268931     History of Changes
Other Study ID Numbers: 24098
Study First Received: December 21, 2005
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
premature birth
motor skills
learning
reaching

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on November 25, 2014