Condition category
Neonatal Diseases
Date applied
16/04/2007
Date assigned
16/07/2007
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Neil McIntosh

ORCID ID

Contact details

Neonatal Unit
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
neil.mcintosh@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2001/R/NE/11

Study information

Scientific title

Acronym

Study hypothesis

When parents of newborn infants are approached for consent to enter their baby in a research trial, shorter and less complex documents are more effective in terms of:
1. Parental understanding of the important details of the research and implications for their baby, and
2. Recruitment of infants to the research study

Ethics approval

Lothian Research Ethics Committee, 01/02/2002, ref: LREC//2001/6/54

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Neonatal research

Intervention

Two consent forms and information sheets, used in:
A. United States of America, and
B. Edinburgh
For the NEOPAIN Multicentre Trial will be tested. The NEOPAIN Trial was an international, randomised, double blind, placebo-controlled trial of routine morphine infusion versus placebo in ventilated preterm infants. The primary outcomes were published in the Lancet in 2004.

Parents will be asked to imagine that their infant was eligible for the study and will be randomised to one of the two forms (A or B), with or without a verbal explanation about the study. After reading the study documentation, they will answer a questionnaire to investigate their understanding, satisfaction and willingness to enrol their infant in the hypothetical study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Parental understanding of the important points of the research study.

Secondary outcome measures

1. Parental satisfaction with information given
2. Parental willingness to allow their baby to participate in research on the basis of the information given

Overall trial start date

30/11/2001

Overall trial end date

31/07/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Parents of infants admitted to the Neonatal Unit within the first 72 hours of life, but not expected to require ventilation.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Parents of infants requiring ventilation
2. Parents who are unable to read or speak English

Recruitment start date

30/11/2001

Recruitment end date

31/07/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatal Unit
Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Organisation

Royal Infirmary of Edinburgh (UK)

Sponsor details

Neonatal Unit
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nhslothian.scot.nhs.uk/hospitals/rie.asp

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Edinburgh)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Published on the Pediatric Academic Society website (http://www.pas-meeting.org/abstracts.htm) (abstract form only):
EM Boyle, Y Freer, S Teunisse, N McIntosh and KJS Anand. Research in neonates - international differences in consent. E-PAS 2006:59:4850.239

Publication citations

Additional files

Editorial Notes