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Development Training in Babies Born Preterm

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movement Training
Social Training
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring premature birth, motor skills, learning, reaching

Eligibility Criteria

6 Weeks - 11 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • Christiana Care Health Systems

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

True Control

Social Training

Movement Training

Arm 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.

This group underwent specific social interactions two times each day with their parents.

This group of preterm infants underwent movement training two times per day with their parents.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2005
Last Updated
April 12, 2013
Sponsor
Christiana Care Health Services
Collaborators
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT00268931
Brief Title
Development Training in Babies Born Preterm
Official Title
Enhanced Developmental Training Experiences in Babies Born Preterm
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
Collaborators
University of Delaware

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
premature birth, motor skills, learning, reaching

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
True Control
Arm Type
No Intervention
Arm 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.
Arm Title
Social Training
Arm Type
Experimental
Arm Description
This group underwent specific social interactions two times each day with their parents.
Arm Title
Movement Training
Arm Type
Experimental
Arm Description
This group of preterm infants underwent movement training two times per day with their parents.
Intervention Type
Behavioral
Intervention Name(s)
Movement Training
Intervention Description
This group of infants underwent specific movement training activities two times per day with their parents.
Intervention Type
Behavioral
Intervention Name(s)
Social Training
Intervention Description
This group underwent special social interactions with their parents two times each day.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
11 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill C. Heathcock, MPT
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James C Galloway, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6734328
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.
Results Reference
background
PubMed Identifier
15623358
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.
Results Reference
background
PubMed Identifier
15330694
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.
Results Reference
background
PubMed Identifier
9599962
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. doi: 10.1177/002221949803100309.
Results Reference
background
PubMed Identifier
12088310
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. doi: 10.1017/s0012162201002298.
Results Reference
background
PubMed Identifier
11842270
Citation
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. doi: 10.1123/mcj.6.1.52.
Results Reference
background
Links:
URL
http://www.udel.edu/PR/UDaily/2004/infant032604.html
Description
University news article

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Development Training in Babies Born Preterm

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