Extreme Preterm Nutrition Study

ISRCTN	ISRCTN19509258
DOI	https://doi.org/10.1186/ISRCTN19509258
Protocol serial number	LWH0502
Sponsor	Liverpool Women's NHS Foundation Trust (UK)
Funder	'Own account', fully funded by Liverpool Women's NHS R&D support funds (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Richard Cooke
Scientific

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

Phone	+44 (0)151 708 9988
Email	mc19@liv.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Extreme Preterm Nutrition Study
Study acronym	ExPN study
Study objectives	Will better nutrition improve head growth and neurodevelopmental outcome in very preterm infants?
Ethics approval(s)	Ethics approval received from Liverpool Children's Research Ethics Committee on 29th September 2003 (ref: 03/08/141/C).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Head circumference at 36 weeks corrected gestational age
Key secondary outcome measure(s)	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
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	140
Key inclusion criteria	Babies (singletons/twins) born less than 29 completed weeks gestation, but at least 24 weeks gestation and above
Key exclusion criteria	Babies born with major congenital malformations, triplets and other higher multiple births
Date of first enrolment	26/01/2004
Date of final enrolment	31/03/2006

Neonatal Unit

Liverpool
L8 7SS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/09/2008		Yes	No
Other publications		01/09/2008		Yes	No

26/10/2022: Internal review.