Extreme Preterm Nutrition Study
| ISRCTN | ISRCTN19509258 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19509258 |
| Secondary identifying numbers | LWH0502 |
- Submission date
- 08/09/2005
- Registration date
- 16/02/2006
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Richard Cooke
Scientific
Scientific
Neonatal Unit
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
| Phone | +44 (0)151 708 9988 |
|---|---|
| mc19@liv.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 26/01/2004 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Neonatal Unit
Liverpool
L8 7SS
United Kingdom
L8 7SS
United Kingdom
Sponsor information
Liverpool Women's NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Crown Street
Liverpool
L8 7SS
England
United Kingdom
| Phone | +44 (0)151 708 9988 |
|---|---|
| lynne.webster@lwh.nhs.uk | |
"ROR" |
https://ror.org/04q5r0746 |
Funders
Funder type
Government
'Own account', fully funded by Liverpool Women's NHS R&D support funds (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 01/09/2008 | Yes | No | ||
| Results article | 01/09/2008 | Yes | No |
Editorial Notes
26/10/2022: Internal review.
