Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
20/08/2015
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 Samir Gupta

ORCID ID

Contact details

South Tees Hospital Trust
The James Cook University Hospital
Marton Road
Cleveland
TS4 3BW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227163238

Study information

Scientific title

Effect of two different volumes of blood transfusion on cardiac function, cerebral and gut hemodynamics in neonates: a randomised controlled trial

Acronym

Study hypothesis

What are the hemodynamic effects of different volumes of blood transfusion in newborn babies: effects on cardiac output, gut and cerebral flow?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neonatal Diseases

Intervention

After taking informed consent the Ultrasonographic and Doppler assessment of cerebral flow, gut flow and cardiac function, would be done 4 hours before, and 4 and 24-30 hours after transfusion. Block randomisation with stratification as per the gestation (less than and equal to and more than 30 weeks gestation) will be done.

Once eligible baby will be randomised into one of the 2 groups:
1. Volume of transfusion 20 ml per kg given over 4 hours
2. Volume of transfusion 10 ml per kg given over 2 hours and repeated with 10 ml per kg transfused over two hours from same donor, 24 hours apart

Each baby will act as control pre transfusion and case post transfusion. Each consented transfusion event will be enrolled as a subject.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Effect of blood transfusion
2. Change in cardiac output post transfusion

Secondary outcome measures

1. Change in gut flow
2. Change in cerebral flow
3. Effect on Hemoglobin concentration

Overall trial start date

01/10/2004

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Babies admitted to the neonatal intensive care unit and requiring blood transfusion (packed cells) as per the unit protocol and guidelines will be eligible for the study.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

70, 57 recruited as of September 2006

Participant exclusion criteria

1. Babies with pneumothorax, pneumomediastinum or pneumoperitoneum during study
2. Hypotension requiring changing ionotropic support at time of transfusion
3. Terminally ill babies
4. Complex congenital heart disease
5. Major congenital anomalies

Recruitment start date

01/10/2004

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Tees Hospital Trust
Cleveland
TS4 3BW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

South Tees Hospitals NHS Trust (UK), 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

Publication citations

Additional files

Editorial Notes