Helping Our Premature Infants ON to Better Motor Skills (HOP-ON) (HOP-ON)
Primary Purpose
Motor Development of Premature Infants
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HOP-ON
SMILES
Sponsored by
About this trial
This is an interventional health services research trial for Motor Development of Premature Infants focused on measuring Premature infants, Motor Development
Eligibility Criteria
Inclusion Criteria:
- Preterm infants born less than 32 weeks of gestation, and progressing well enough to have either been recently discharged from hospital, or being discharged from hospital within the next two weeks.
- Parent/s aged between 16-60 years of age, who have a preterm infant - born less than 32 weeks of gestation.
Both parent and infant inclusion criteria must be met for inclusion in the study.
Exclusion Criteria:
- Parent/s of infants who are still receiving hospital care at 3 months adjusted age, and their premature infants who are still receiving hospital care at 3 months adjusted age.
- Parent/s of multiple births, where the number of infants is greater than two (three of more infants).
- To avoid excessive travel costs, infants born outside the defined catchment area will be excluded from the study. There are no other exclusion criteria.
Sites / Locations
- Derby Hospitals NHS Foundation Trust
- University Hospitals Leicester NHS Trust
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HOP-ON intervention
SMILES
Arm Description
Participants will receive a CD-ROM (or DVD and booklet if no access to computer) highlighting motor skills which could be encouraged with premature infants
Participants will received a CD-ROM (or DVD and booklet if no access to a computer) which contains information on interacting with their premature infant
Outcomes
Primary Outcome Measures
Difference in Bayley III motor scales scores
Secondary Outcome Measures
Full Information
NCT ID
NCT01281358
First Posted
January 5, 2011
Last Updated
December 1, 2015
Sponsor
University of Nottingham
Collaborators
Action Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT01281358
Brief Title
Helping Our Premature Infants ON to Better Motor Skills (HOP-ON)
Acronym
HOP-ON
Official Title
Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Action Medical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Infants born very premature have biological risk factors for later developmental coordination disorder. Parental stereotyping of infants as fragile and other environmental factors, such as spending long periods laying on their backs, also contribute to motor delay. This study aims to develop and evaluate a computer-based intervention (Helping Our Premature infants ON to better motor skills - HOP-ON) for parents of preterm infants. HOP-ON will model evidence based strategies to develop infants' fine and gross motor skills, and aims to reduce parental stereotyping. It is hypothesised that infants whose parents receive the HOPON CD-ROM/DVD and Booklet will have better motor skills at 12 months adjusted age compared to those whose parents receive a control CD-ROM/DVD and booklet. Parents of infants born at less than 32 weeks gestation (target n = 138) will be recruited prior to discharge from the neonatal unit and randomised to either HOP-ON or control. The primary outcome is motor score (Bayleys III) at 12 months adjusted age. Other outcomes are parental confidence and perceptions of infant capability at 3 months and quality of movement, infant growth, fine and gross motor movement and parenting stress at 12 months. Data will be analysed blind to study condition and on an intention to treat basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Development of Premature Infants
Keywords
Premature infants, Motor Development
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HOP-ON intervention
Arm Type
Experimental
Arm Description
Participants will receive a CD-ROM (or DVD and booklet if no access to computer) highlighting motor skills which could be encouraged with premature infants
Arm Title
SMILES
Arm Type
Active Comparator
Arm Description
Participants will received a CD-ROM (or DVD and booklet if no access to a computer) which contains information on interacting with their premature infant
Intervention Type
Other
Intervention Name(s)
HOP-ON
Intervention Description
A programme of activities which promote motor development
Intervention Type
Other
Intervention Name(s)
SMILES
Intervention Description
Details are provided on ways for parents to interact with their premature infants
Primary Outcome Measure Information:
Title
Difference in Bayley III motor scales scores
Time Frame
12 months corrected age
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants born less than 32 weeks of gestation, and progressing well enough to have either been recently discharged from hospital, or being discharged from hospital within the next two weeks.
Parent/s aged between 16-60 years of age, who have a preterm infant - born less than 32 weeks of gestation.
Both parent and infant inclusion criteria must be met for inclusion in the study.
Exclusion Criteria:
Parent/s of infants who are still receiving hospital care at 3 months adjusted age, and their premature infants who are still receiving hospital care at 3 months adjusted age.
Parent/s of multiple births, where the number of infants is greater than two (three of more infants).
To avoid excessive travel costs, infants born outside the defined catchment area will be excluded from the study. There are no other exclusion criteria.
Facility Information:
Facility Name
Derby Hospitals NHS Foundation Trust
City
Derby
Country
United Kingdom
Facility Name
University Hospitals Leicester NHS Trust
City
Leicester
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
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Helping Our Premature Infants ON to Better Motor Skills (HOP-ON)
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