Helping Our Premature Infants ON to Better Motor Skills (HOP-ON)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Motor Development of Premature Infants |
Other: HOP-ON Other: SMILES |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature |
- Difference in Bayley III motor scales scores [ Time Frame: 12 months corrected age ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HOP-ON intervention
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
|
Other: HOP-ON
A programme of activities which promote motor development
|
|
Active Comparator: SMILES
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
|
Other: SMILES
Details are provided on ways for parents to interact with their premature infants
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United Kingdom | |
| Derby Hospitals NHS Foundation Trust | |
| Derby, United Kingdom | |
| University Hospitals Leicester NHS Trust | |
| Leicester, United Kingdom | |
| Nottingham University Hospitals NHS Trust | |
| Nottingham, United Kingdom | |
More Information
No publications provided
| Responsible Party: | University of Nottingham |
| ClinicalTrials.gov Identifier: | NCT01281358 History of Changes |
| Other Study ID Numbers: | 10027 |
| Study First Received: | January 5, 2011 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Nottingham:
|
Premature infants Motor Development |
ClinicalTrials.gov processed this record on June 13, 2013