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Standardised, Concentrated and Additional Macronutrients in neonatal Parenteral nutrition study
ISRCTN ISRCTN76597892
DOI 10.1186/ISRCTN76597892
ClinicalTrials.gov identifier
EudraCT number
Public title Standardised, Concentrated and Additional Macronutrients in neonatal Parenteral nutrition study
Scientific title Standardised, Concentrated, Additional Macronutrients, Parenteral (SCAMP) nutrition in very preterm infants: a phase IV randomised, controlled study of macronutrient intake, growth and other aspects of neonatal care
Acronym SCAMP
Serial number at source LWH 0776
Study hypothesis Maximising the macronutrient content of the standardised, concentrated neonatal parenteral nutrition formulation will improve head growth in very preterm infants.
Lay summary Not provided at time of registration
Ethics approval Central Manchester Research Ethics Committee, North West Strategic Health Authority. Approval expected on 11/05/2009 (ref: 09/H1008/91).
Study design Phase IV randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Head growth in very preterm infants
Participants - inclusion criteria All infants (both males ane females) born less than 29 weeks gestation and weighing <1,200 grams born at Liverpool Women's Hospital (LWH) will be eligible. All infants meeting these criteria born outside LWH will be eligible if transfer takes place to LWH within 48 hours.
Participants - exclusion criteria 1. Infants born in poor condition in the first 72 hours and are unlikely to survive the first week after birth
2. Infants diagnosed with major congenital and chromosomal abnormalities know to affect head growth or gastrointestinal function
Anticipated start date 01/06/2009
Anticipated end date 01/05/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 150 infants over two years
Interventions Informed consent and randomisation to the trial. Intravenous administration of either scNPN (standard) or scNPNmax (study) solution. Daily collection of routine biochemical monitoring data and all oral and intravenous fluid/drug administration on the case report form. All infants will be measured for weight, lower leg length, occipito-frontal circumference and length on day 0 (baseline) day 7,14,21,28. The total duration of interventions will be until the infant is 28 days old. The follow up will consist of weekly growth measurements until the infant reaches 36/40 post conceptual age and then neuo-developmental follow-up at 18 months corrected gestational age.
Primary outcome measure(s) To compare early head growth in premature infants receiving a standardised formulation of parenteral nutrition(scNPN) with a standardised, concentrated formulation of parenteral nutrition containing additional protein, fat and carbohydrate (scNPNmax). Timepoints: when the infant is 28 days old (having already had growth measurements on days 0, 7, 14 and 21).
Secondary outcome measure(s) 1. Weight gain and linear growth
2. Monitoring supplementary infusion requirements such as insulin and electrolytes
3. Routine biochemical measures of PN tolerance
4. Cost-benefit analysis
5. Efficiency and safety of prescribing and administration
6. Neurodevelopmental outcome (Bayley III)

Timepoints:
For outcomes 1 - 5: At 28 days and 36 weeks post conceptual age
For outcome 6: At 18 months corrected for gestational age
Sources of funding BLISS (UK) - Innovations in Care Programme
Trial website
Publications 1. 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21663622
2. 2013 results in: http://adc.bmj.com/content/98/Suppl_1/A77.3.abstract
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24379229
Contact name Mrs  Sarah  Azurdia
  Address Lead Research Nurse
Department of Neonatology
Liverpool Women's Hospital NHS Foundation Trust
Crown Street
  City/town Liverpool
  Zip/Postcode L8 7SS
  Country United Kingdom
  Tel +44 (0)151 7089988 x 4382
  Fax +44 (0)151 7024313
  Email sarah.azurdia@lwh.nhs.uk
Sponsor Liverpool Women's Hospital NHS Foundation Trust (UK)
  Address c/o Ms Gillian Vernon
Crown Street
  City/town Liverpool
  Zip/Postcode L8 7SS
  Country United Kingdom
  Tel +44 (0)151 7024346
  Fax +44 (0)151 7024024
  Email gillian.vernon@lwh.nhs.uk
  Sponsor website: http://www.lwh.me.uk/
Date applied 23/04/2009
Last edited 26/02/2014
Date ISRCTN assigned 28/05/2009
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