Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/05/2012
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 Fiona Weir

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0051113384

Study information

Scientific title

Acronym

Study hypothesis

A continuous infusion of bicarbonate in very low birth weight infants over the first four days of life will reduce the need for bolus bicarbonate or fluid infusions to correct academia.

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

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

Neonatal Diseases: Metabolic acidosis

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Continuous weak alkali infusion may prevent acidosis from occurring and reduce the need for boluses of fluid or bicarbonate.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/10/2001

Overall trial end date

30/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Babies 32 weeks gestational age weighing <1000 g

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

30/10/2001

Recruitment end date

30/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Brighton and Sussex University Hospitals NHS Trust (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

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15846651

Publication citations

  1. Results

    Lawn CJ, Weir FJ, McGuire W, Base administration or fluid bolus for preventing morbidity and mortality in preterm infants with metabolic acidosis., Cochrane Database Syst Rev, 2005, 2, CD003215, doi: 10.1002/14651858.CD003215.pub2.

Additional files

Editorial Notes