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Development Training in Babies Born Preterm

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Christiana Care Health Services

Status

Completed

Conditions

Premature Birth

Treatments

Behavioral: Social Training
Behavioral: Movement Training

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

6 to 11 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 3 patient groups

True Control
No Intervention group
Description:
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 group
Description:
This group underwent specific social interactions two times each day with their parents.
Treatment:
Behavioral: Social Training
Movement Training
Experimental group
Description:
This group of preterm infants underwent movement training two times per day with their parents.
Treatment:
Behavioral: Movement Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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