Condition category
Neonatal Diseases
Date applied
08/09/2005
Date assigned
16/02/2006
Last edited
01/09/2008
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 Richard Cooke

ORCID ID

Contact details

Neonatal Unit
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 708 9988
mc19@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LWH0502

Study information

Scientific title

Acronym

ExPN study

Study hypothesis

Will better nutrition improve head growth and neurodevelopmental outcome in very preterm infants?

Ethics approval

Ethics approval received from Liverpool Children's Research Ethics Committee on 29th September 2003 (ref: 03/08/141/C).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Extreme prematurity

Intervention

Hyperalimentation - providing 20% more calories in total parenteral nutrition followed by 20% more protein in enteral feeds, from birth to 34 weeks corrected gestational age
Control: usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Head circumference at 36 weeks corrected gestational age

Secondary outcome measures

1. Quantitative cranial Magnetic Resonance Imaging (MRI) analysis at 40 weeks corrected gestational age
2. Neurodevelopmental assessment using Bayley's Scales of Infant Development II (BSID-II) at three months and nine months post-term

Overall trial start date

26/01/2004

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Babies (singletons/twins) born less than 29 completed weeks gestation, but at least 24 weeks gestation and above

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

140

Participant exclusion criteria

Babies born with major congenital malformations, triplets and other higher multiple births

Recruitment start date

26/01/2004

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatal Unit
Liverpool
L8 7SS
United Kingdom

Sponsor information

Organisation

Liverpool Women's NHS Foundation Trust (UK)

Sponsor details

Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 708 9988
lynne.webster@lwh.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

'Own account', fully funded by Liverpool Women's NHS R&D support funds (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

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/18252814 (neonatal outcomes)
2. http://www.ncbi.nlm.nih.gov/pubmed/18285378 (MRI and developmental outcomes)

Publication citations

  1. Tan MJ, Cooke RW, Improving head growth in very preterm infants--a randomised controlled trial I: neonatal outcomes., Arch. Dis. Child. Fetal Neonatal Ed., 2008, 93, 5, F337-41, doi: 10.1136/adc.2007.124230.

  2. Tan M, Abernethy L, Cooke R, Improving head growth in preterm infants--a randomised controlled trial II: MRI and developmental outcomes in the first year., Arch. Dis. Child. Fetal Neonatal Ed., 2008, 93, 5, F342-6, doi: 10.1136/adc.2007.124255.

Additional files

Editorial Notes