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PPrime: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study) (PPrime)

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ClinicalTrials.gov Identifier: NCT01055548
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the pilot study is to explore and identify the issues of concern to parents whose babies have been cared for in a neonatal unit and exposed to imaging, its influence on diagnosis and information-giving process

Condition or disease
Parents of Preterm Infants Born Before 33 Weeks Gestation

Detailed Description:

The aim is to explore the recent experience and views of parents in a qualitative way to assist the development of a questionnaire which can be used with a much larger group of parents. The interview guide with the topics to be covered will include: expectations, concerns and issues relating to the equipment used with their baby, any investigations, including cranial ultrasound and MR imaging and the information provided.

The data collected will then inform the development of a standard instrument or questionnaire which will be used with parents participating in a trial using a randomised design to compare the influence of MR and ultrasound-based information on parental perceptions, stress and coping in association with healthcare usage and costs.


Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)
Study Start Date : October 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Parents of babies born before 33 weeks gestation


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parents of babies born before 33 week's gestation
Criteria

Inclusion Criteria:

  • Parents of babies born before 33 weeks gestation Parents who are 16 years of age or older Parents who are able to give informed consent Parents who are able to take part in interviews which are conducted in English

Exclusion Criteria:

  • Parents who are under 16 years of age Parents who are unable to give informed consent Parents who are unable to take part in interviews which are conducted in English Parents where there are possible or know child protection issues
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): NCT01055548


Locations
United Kingdom
Hammersmith Hospital
London, United Kingdom, W12OHS
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Professor D Edwards Imperial College London
Principal Investigator: Dr D Azzopardi Imperial College London
Principal Investigator: Dr M Redshaw Imperial College London
More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01055548     History of Changes
Other Study ID Numbers: EudraCT 2009-0138888-19
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: January 2010

Keywords provided by Imperial College London:
Preterm
Perinatal
Ultrasound
Cerebral palsy
Anxiety
Parents