Motor Development of Premature Infants Clinical Trial
— HOP-ONOfficial title:
Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature
| Verified date | December 2015 |
| Source | University of Nottingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Derby Hospitals NHS Foundation Trust | Derby | |
| United Kingdom | University Hospitals Leicester NHS Trust | Leicester | |
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham | Action Medical Research |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in Bayley III motor scales scores | 12 months corrected age | No |