Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCH 06-04
Study information
Scientific title
Acronym
Study hypothesis
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
Ethical approval from the eight local research ethics committees relating to the participating neonatal and community child health services (added 20/11/09)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Rate of ascertainment of outcome in all areas of development. Target >95%.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1996
Overall trial end date
01/04/2000
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
472 (236 in each arm) (added 20/11/09)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/09/1996
Recruitment end date
01/04/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Child Health
Leicester
LE2 7LX
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Mother and Child Health National Research and Development Programme (UK)
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
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11731389
Publication citations
-
Results
Field D, Draper ES, Gompels MJ, Green C, Johnson A, Shortland D, Blair M, Manktelow B, Lamming CR, Law C, Measuring later health status of high risk infants: randomised comparison of two simple methods of data collection., BMJ, 2001, 323, 7324, 1276-1281.