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
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
-
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.