Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.lwh.me.uk/

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

Results - basic reporting

Publication summary

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

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.

Editorial Notes