Contact information
Type
Scientific
Primary contact
Prof Malcolm Levene
ORCID ID
Contact details
Leeds General Infirmary
Clarendon Wing D Floor
Belmont Grove
Leeds
LS2 9NS
United Kingdom
+44 (0)113 292 3900
m.i.levene@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9436455
Study information
Scientific title
Randomised Asphyxia Study (RAST) - pilot phase. A multi-centre controlled study of magnesium infusion following severe birth asphyxia
Acronym
RAST
Study hypothesis
Birth asphyxia remains one of the most important causes of potentially avoidable death and disability in normally formed fullterm babies in Britain. One of the most important causes of neuronal compromise following hypoxic-ischaemic insult is excessive calcium entry through the specific glutamate ligand port referred to as the N-methyl-D-aspartate (NMDA) channel. Magnesium ions block depolarization of the NMDA channel and MgSO4 has been widely used in pregnancy to prevent premature labour and to treat severe pregnancy induced hypertension. In these dosage regimens it appears to be safe to the neonate.
This pilot study proposes to evaluate the feasibility of using MgSO4 as a potential rescue therapy given shortly after resuscitation in infants who are severely depressed 10 minutes after birth. The pilot study will address:
1. The earliest postnatal age at which MgSO4 can be given with informed parental consent
2. Safety and pharmacokinetics of MgSO4 (250 mg/kg)
3. Feasibility of recruiting sufficient babies to have suitable statistical power to show an effect
4. Appropriate end point measures
The proposed pilot study will last 18 months and we aim to enroll at least 75 babies.
Ethics approval
Not provided at time of registration
Study design
Multi-centre controlled study
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 contact details to request a participant information sheet
Condition
Neonatal diseases: Neonatal diseases; Respiratory tract diseases: Other respiratory tract disease
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
09/01/1995
Overall trial end date
31/03/1997
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
75 babies
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
09/01/1995
Recruitment end date
31/03/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds General Infirmary
Leeds
LS2 9NS
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
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
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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