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

Not Applicable

Completed

• Conditions: Motor Development of Premature Infants
• Interventions: Other: SMILES; Other: HOP-ON

• Registration Number: NCT01281358
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2011-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMILES	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
HOP-ON intervention	HOP-ON	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

Primary Outcome Measures

Name	Time	Method
Difference in Bayley III motor scales scores	12 months corrected age

Trial Locations

Locations (3)

Derby Hospitals NHS Foundation Trust; 🇬🇧 Derby, United Kingdom

University Hospitals Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom