Randomised Asphyxia Study (RAST) - pilot phase. A multi-centre controlled study of magnesium infusion following severe birth asphyxia

ISRCTN	ISRCTN71882337
DOI	https://doi.org/10.1186/ISRCTN71882337
Secondary identifying numbers	G9436455

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 24/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Malcolm Levene
Scientific

Leeds General Infirmary
Clarendon Wing D Floor
Belmont Grove
Leeds
LS2 9NS
United Kingdom

Phone	+44 (0)113 292 3900
Email	m.i.levene@leeds.ac.uk

Study information

Study design	Multi-centre controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Randomised Asphyxia Study (RAST) - pilot phase. A multi-centre controlled study of magnesium infusion following severe birth asphyxia
Study acronym	RAST
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal diseases: Neonatal diseases; Respiratory tract diseases: Other respiratory tract disease
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	09/01/1995
Completion date	31/03/1997

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	75 babies
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	09/01/1995
Date of final enrolment	31/03/1997

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Leeds General Infirmary

Leeds
LS2 9NS
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/10/2019: No publications found. Verifying results with principal investigator
06/09/2016: No publications found, verifying study status with principal investigator.