Helping Our Premature Infants ON to Better Motor Skills (HOP-ON)

Study Overview
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Brief Summary
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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.

Official Title
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Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature

Conditions
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Motor Development of Premature Infants

Intervention / Treatment
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* Other: HOP-ON
* Other: SMILES


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOP-ON intervention<br>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<br>* A programme of activities which promote motor development<br>|
| Active Comparator: SMILES<br>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<br>* Details are provided on ways for parents to interact with their premature infants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Bayley III motor scales scores |  | 12 months corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infants, Motor Development