Condition category
Neonatal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
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

Dr Simon Mitchell

ORCID ID

Contact details

Central Manchester & Manchester Children's University Hospitals SMH
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom
+44
simon.mitchell@cmmc.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0453150119

Study information

Scientific title

Acronym

Study hypothesis

To determine whether a WIRA lamp in addition to a standard incubator is more effective than standard incubator alone in preventing extremely premature babies from getting cold during insertion of umbilical lines after admission to neonatal medical unit.

Ethics approval

Central Manchester Research Ethics Committee, ref 04/Q1407/75, 15/07/2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neonatal Diseases

Intervention

Infants will be allocated to conventional warming or conventional plus WIRA during admission/stabilisation by block randomisation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Axillary temperature at completion of umbilical line insertion

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Infants below 28 weeks admitted to neonatal unit

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

44 infants

Participant exclusion criteria

1. Parental consent not obtained
2. Major congenital abnormality

Recruitment start date

01/09/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central Manchester & Manchester Children's University Hospitals SMH
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

Samanta S, Mitchell S. Effect of water-filtered Infra-red A heating on thermal stability during umbilical line insertion in preterm infants. Archives of Disease in Childhood 2008;93(suppl 2):pw396

Publication citations

Additional files

Editorial Notes