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

NCT ID: NCT01281358

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-11-30

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.

Detailed Description

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Conditions

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Motor Development of Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HOP-ON intervention

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

Group Type EXPERIMENTAL

HOP-ON

Intervention Type OTHER

A programme of activities which promote motor development

SMILES

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

Group Type ACTIVE_COMPARATOR

SMILES

Intervention Type OTHER

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

Interventions

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HOP-ON

A programme of activities which promote motor development

Intervention Type OTHER

SMILES

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

Intervention Type OTHER

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.

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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Action Medical Research

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Derby Hospitals NHS Foundation Trust

Derby, , United Kingdom

Site Status

University Hospitals Leicester NHS Trust

Leicester, , United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10027

Identifier Type: -

Identifier Source: org_study_id