Trials / Completed
CompletedNCT01281358
Helping Our Premature Infants ON to Better Motor Skills (HOP-ON)
Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- University of Nottingham · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | HOP-ON | A programme of activities which promote motor development |
| OTHER | SMILES | Details are provided on ways for parents to interact with their premature infants |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2011-01-21
- Last updated
- 2015-12-02
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01281358. Inclusion in this directory is not an endorsement.