Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2009
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 David Field

ORCID ID

Contact details

Department of Child Health
University of Leicester
RKCSB
LRI
Leicester
LE2 7LX
United Kingdom
+44 (0)116 2585502

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes