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
-
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.
-
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.