Study to examine the effects of different styles of consent documentation on parental understanding and recruitment of babies in neonatal research
| ISRCTN | ISRCTN56014081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56014081 |
| Secondary identifying numbers | 2001/R/NE/11 |
- Submission date
- 16/04/2007
- Registration date
- 16/07/2007
- Last edited
- 09/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Neil McIntosh
Scientific
Scientific
Neonatal Unit
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
| neil.mcintosh@ed.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | |
| Study objectives | 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(s) | Lothian Research Ethics Committee, 01/02/2002, ref: LREC//2001/6/54 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/11/2001 |
| Completion date | 31/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Parents of infants admitted to the Neonatal Unit within the first 72 hours of life, but not expected to require ventilation. |
| Key exclusion criteria | 1. Parents of infants requiring ventilation 2. Parents who are unable to read or speak English |
| Date of first enrolment | 30/11/2001 |
| Date of final enrolment | 31/07/2002 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Neonatal Unit
Edinburgh
EH16 4SA
United Kingdom
EH16 4SA
United Kingdom
Sponsor information
Royal Infirmary of Edinburgh (UK)
Hospital/treatment centre
Hospital/treatment centre
Neonatal Unit
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
Scotland
United Kingdom
| Website | http://www.nhslothian.scot.nhs.uk/hospitals/rie.asp |
|---|---|
"ROR" |
https://ror.org/009bsy196 |
Funders
Funder type
Other
Investigator initiated and funded (Edinburgh)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | No | No |
