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

This study has been completed.
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
North and South West Thames Perinatal Networks
National Perinatal Epidemiology Unit
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01055548
First received: January 22, 2010
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

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
Parents of Preterm Infants Born Before 33 Weeks Gestation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2009
Groups/Cohorts
Parents of babies 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.

  Eligibility

Ages Eligible for Study:   up to 33 Weeks
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055548

Locations
United Kingdom
Hammersmith Hospital
London, United Kingdom, W12OHS
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
North and South West Thames Perinatal Networks
National Perinatal Epidemiology Unit
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

No publications provided

Responsible Party: Professor David Edwards, Professor of Neonatal Medicine, Chief Investigator, Imperial College London
ClinicalTrials.gov Identifier: NCT01055548     History of Changes
Other Study ID Numbers: EudraCT 2009-0138888-19
Study First Received: January 22, 2010
Last Updated: January 26, 2010
Health Authority: United Kingdon:National Research Ethics Service

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

ClinicalTrials.gov processed this record on November 20, 2014