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

NCT ID: NCT01055548

Last Updated: 2015-06-03

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Parents of Preterm Infants Born Before 33 Weeks Gestation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Parents of babies born before 33 weeks gestation

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Professor D Edwards

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Dr D Azzopardi

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Dr M Redshaw

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Hammersmith Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCT 2009-0138888-19

Identifier Type: -

Identifier Source: org_study_id

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