Development Training in Babies Born Preterm - Full Text View

Sponsors and Collaborators:	Christiana Care Health Services University of Delaware
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00268931

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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
True Control: No Intervention 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.
Social Training: Experimental 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.
Movement Training: Experimental 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

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:

University news article This link exits the ClinicalTrials.gov site

Publications:

Fagen JW, Morrongiello BA, Rovee-Collier C, Gekoski MJ. Expectancies and memory retrieval in three-month-old infants. Child Dev. 1984 Jun;55(3):936-43.

Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The relative kicking frequency of infants born full-term and preterm during learning and short-term and long-term memory periods of the mobile paradigm. Phys Ther. 2005 Jan;85(1):8-18.

Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The performance of infants born preterm and full-term in the mobile paradigm: learning and memory. Phys Ther. 2004 Sep;84(9):808-21.

Cherkes-Julkowski M. Learning disability, attention-deficit disorder, and language impairment as outcomes of prematurity: a longitudinal descriptive study. J Learn Disabil. 1998 May-Jun;31(3):294-306.

de Vries AM, de Groot L. Transient dystonias revisited: a comparative study of preterm and term children at 2 1/2 years of age. Dev Med Child Neurol. 2002 Jun;44(6):415-21.

Angulo-Kinzler RM, Ulrich B, Thelen E. Three-month-old infants can select specific leg motor solutions. Motor Control. 2002 Jan;6(1):52-68.

Responsible Party:	University of Delaware ( James C. (Cole) Galloway )
Study ID Numbers:	24098
Study First Received:	December 21, 2005
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00268931 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:

premature birth
motor skills
learning
reaching

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

Additional relevant MeSH terms:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on May 06, 2009