Condition category
Neonatal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Sarah Azurdia


Contact details

Lead Research Nurse
Department of Neonatology
Liverpool Women's Hospital NHS Foundation Trust
Crown Street
L8 7SS
United Kingdom
+44 (0)151 7089988 x 4382

Additional identifiers

EudraCT number 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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Head growth in very preterm infants


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



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)

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Lead Research Nurse
L8 7SS
United Kingdom

Sponsor information


Liverpool Women's Hospital NHS Foundation Trust (UK)

Sponsor details

c/o Ms Gillian Vernon
Crown Street
L8 7SS
United Kingdom
+44 (0)151 7024346

Sponsor type




Funder type


Funder name

BLISS (UK) - Innovations in Care Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:
2. 2013 results in:
3. 2014 results in:
4. 2014 results in:

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes