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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281358
First Posted: January 21, 2011
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Action Medical Research
Information provided by (Responsible Party):
University of Nottingham
  Purpose
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.

Condition Intervention
Motor Development of Premature Infants Other: HOP-ON Other: SMILES

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Difference in Bayley III motor scales scores [ Time Frame: 12 months corrected age ]

Enrollment: 160
Study Start Date: March 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Other: HOP-ON
A programme of activities which promote motor development
Active Comparator: 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
Other: SMILES
Details are provided on ways for parents to interact with their premature infants

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281358


Locations
United Kingdom
Derby Hospitals NHS Foundation Trust
Derby, United Kingdom
University Hospitals Leicester NHS Trust
Leicester, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Sponsors and Collaborators
University of Nottingham
Action Medical Research
  More Information

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01281358     History of Changes
Other Study ID Numbers: 10027
First Submitted: January 5, 2011
First Posted: January 21, 2011
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by University of Nottingham:
Premature infants
Motor Development

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications