Clinical trial NCT01281358: Helping Our Premature Infants ON to Better Motor Skills (HOP-ON)
Official title: Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Development of Premature Infants
Keywords: Premature infants
Motor Development
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Action Medical Research
First posted: 2011-01-21
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Difference in Bayley III motor scales scores
timeFrame: 12 months corrected age
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Derby Hospitals NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References: