Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/09/2016
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

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

06/09/2016: No publications found, verifying study status with principal investigator.