NCT01281358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

3.7 years

First QC Date

January 5, 2011

Last Update Submit

December 1, 2015

Conditions

Motor Development of Premature Infants

Keywords

Premature infantsMotor Development

Outcome Measures

Primary Outcomes (1)

  • Difference in Bayley III motor scales scores

    12 months corrected age

Study Arms (2)

HOP-ON intervention

EXPERIMENTAL

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

SMILES

ACTIVE COMPARATOR

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

Interventions

HOP-ONOTHER

A programme of activities which promote motor development

HOP-ON intervention
SMILESOTHER

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

SMILES

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Derby Hospitals NHS Foundation Trust

Derby, United Kingdom

Location

University Hospitals Leicester NHS Trust

Leicester, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 21, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

GB(3)