Development Training in Babies Born Preterm

Premature Birth Clinical Trial

Official title:

Enhanced Developmental Training Experiences in Babies Born Preterm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268931
• Other study ID #: 24098
• Status: Completed
• Phase: N/A
• First received: December 21, 2005
• Last updated: April 12, 2013
• Start date: August 2004
• Est. completion date: April 2008

Study information

• Verified date: April 2013
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 11 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Movement Training
This group of infants underwent specific movement training activities two times per day with their parents.
• Social Training
This group underwent special social interactions with their parents two times each day.

Locations

Country	Name	City	State
United States	Christiana Care Health Systems	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	University of Delaware

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks	No

External Links

•   University news article