Contact information
Type
Scientific
Primary contact
Mrs Sarah Azurdia
ORCID ID
Contact details
Lead Research Nurse
Department of Neonatology
Liverpool Women's Hospital NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 7089988 x 4382
sarah.azurdia@lwh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LWH 0776
Study information
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
Study hypothesis
Maximising the macronutrient content of the standardised, concentrated neonatal parenteral nutrition formulation will improve head growth in very preterm infants.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Head growth in very preterm infants
Intervention
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.
Intervention type
Drug
Phase
Phase IV
Drug names
Neonatal parenteral nutrition formulation
Primary outcome measure
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 measures
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
Overall trial start date
01/06/2009
Overall trial end date
01/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
150 infants over two years
Participant 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
Recruitment start date
01/06/2009
Recruitment end date
01/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lead Research Nurse
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
Liverpool Women's Hospital NHS Foundation Trust (UK)
Sponsor details
c/o Ms Gillian Vernon
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 7024346
gillian.vernon@lwh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
BLISS (UK) - Innovations in Care Programme
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
Basic results (scientific)
Publication list
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
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25552279
Publication citations
-
Protocol
Morgan C, Herwitker S, Badhawi I, Hart A, Tan M, Mayes K, Newland P, Turner MA, SCAMP: standardised, concentrated, additional macronutrients, parenteral nutrition in very preterm infants: a phase IV randomised, controlled exploratory study of macronutrient intake, growth and other aspects of neonatal care., BMC Pediatr, 2011, 11, 53, doi: 10.1186/1471-2431-11-53.
-
Results
Morgan C, McGowan P, Herwitker S, Hart AE, Turner MA, Postnatal head growth in preterm infants: a randomized controlled parenteral nutrition study., Pediatrics, 2014, 133, 1, e120-8, doi: 10.1542/peds.2013-2207.
-
Results
Whitby T, McGowan P, Turner MA, Morgan C, Concentrated parenteral nutrition solutions and central venous catheter complications in preterm infants, Arch Dis Child Fetal Neonatal Ed, 2014 , doi: 10.1136/archdischild-2014-306409.