Measuring the outcome of neonatal intensive care: a randomised controlled trial of two methods of data collection.
| ISRCTN | ISRCTN14162250 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14162250 |
| Secondary identifying numbers | MCH 06-04 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/12/2009
- 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 David Field
Scientific
Scientific
Department of Child Health
University of Leicester
RKCSB
LRI
Leicester
LE2 7LX
United Kingdom
| Phone | +44 (0)116 2585502 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | |
| Study objectives | To compare two simple and inexpensive methods of obtaining long term health status data for high risk newborns. The need for ongoing national outcome data for these babies has been high lighted in a number of national reports. To be successful either method would need to provide outcome data on 95% of children alive at a corrected age of two years. |
| Ethics approval(s) | Ethical approval from the eight local research ethics committees relating to the participating neonatal and community child health services (added 20/11/09) |
| Health condition(s) or problem(s) studied | Neonatal diseases, Neonatal intesive care outcomes |
| Intervention | Outcome was measured at 2 years. The two approaches being tested were: 1. A questionnaire about health status completed by parents when the child reached a corrected age of 2 years 2. A questionnaire completed by a clerk based in the local community child service when the child reached a corrected age of 2 years. The clerk used routine information collected about the child. Both questionnaires were based on a consensus statement developed in the early 1990s about the measurement of health status at 2 years. Nine hospitals in two old NHS regions (Trent and Wessex) were randomly allocated to one of the two methods. Parents gave written consent for the inclusion of the child prior to discharge. For those in the 'parent arm' intermittent contact was maintained by using birthday and Christmas cards to prompt the family to inform the research team about changes of address. The clerk based in the child health dept. collected data regarding hospital attendances, copies of out patient letters etc. Intermittent telephone contact to the health visitor was also used. At the end of the study a 10% sample of children (half normal, half abnormal) were selected for independent examination to determine if data supplied by both methods were accurate. ONS flagging was used to prevent us contacting a family where the child had died. |
| Intervention type | Other |
| Primary outcome measure | Rate of ascertainment of outcome in all areas of development. Target >95%. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/1996 |
| Completion date | 01/04/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 472 (236 in each arm) (added 20/11/09) |
| Key inclusion criteria | For purposes of the investigation the "at risk" group will be defined as: any baby born less than or equal to 32 weeks gestation. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/09/1996 |
| Date of final enrolment | 01/04/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Child Health
Leicester
LE2 7LX
United Kingdom
LE2 7LX
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Mother and Child Health National Research and Development Programme (UK)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2001 | Yes | No |
