Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/11/2010
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 Steven Ryan

ORCID ID

Contact details

Neonatal Unit
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Condition

Neonatal diseases

Intervention

Standard parenteral nutrition vs novel formulation with replacement of any chloride dose >3 mmol/kg/day as acetate

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

01/07/1995

Overall trial end date

30/07/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Preterm neonates under 32 weeks gestation were entered into the study if they were still receiving intravenous glucose/electrolyte solution on day 3, but not receiving enteral nutrition.

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

Added as of 23/05/2008: 30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/1995

Recruitment end date

30/07/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatal Unit
Liverpool
L8 7SS
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 North West (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

1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9279176

Publication citations

  1. Results

    Peters O, Ryan S, Matthew L, Cheng K, Lunn J, Randomised controlled trial of acetate in preterm neonates receiving parenteral nutrition., Arch. Dis. Child. Fetal Neonatal Ed., 1997, 77, 1, F12-5.

Additional files

Editorial Notes