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

Sponsors

Lead Sponsor: University of Nottingham

Collaborator: Action Medical Research

Source University of Nottingham
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.

Overall Status Completed
Start Date 2011-03-01
Completion Date 2014-11-01
Primary Completion Date 2014-11-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Difference in Bayley III motor scales scores 12 months corrected age
Enrollment 160
Condition
Intervention

Intervention Type: Other

Intervention Name: HOP-ON

Description: A programme of activities which promote motor development

Arm Group Label: HOP-ON intervention

Intervention Type: Other

Intervention Name: SMILES

Description: Details are provided on ways for parents to interact with their premature infants

Arm Group Label: SMILES

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.

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility:
Derby Hospitals NHS Foundation Trust | Derby, United Kingdom
University Hospitals Leicester NHS Trust | Leicester, United Kingdom
Nottingham University Hospitals NHS Trust | Nottingham, United Kingdom
Location Countries

United Kingdom

Verification Date

2015-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: HOP-ON intervention

Type: Experimental

Description: 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

Label: SMILES

Type: Active Comparator

Description: 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

Acronym HOP-ON
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: Single (Outcomes Assessor)

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