Standardised, Concentrated and Additional Macronutrients in neonatal Parenteral nutrition study

ISRCTN	ISRCTN76597892
DOI	https://doi.org/10.1186/ISRCTN76597892
Secondary identifying numbers	LWH 0776

Submission date: 23/04/2009
Registration date: 28/05/2009
Last edited: 27/11/2023

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

Mrs Sarah Azurdia
Scientific

Lead Research Nurse
Department of Neonatology
Liverpool Women's Hospital NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 7089988 x 4382
Email	sarah.azurdia@lwh.nhs.uk

Study information

Study design	Phase IV randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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 acronym	SCAMP
Study objectives	Maximising the macronutrient content of the standardised, concentrated neonatal parenteral nutrition formulation will improve head growth in very preterm infants.
Ethics approval(s)	Central Manchester Research Ethics Committee, North West Strategic Health Authority. Approval expected on 11/05/2009 (ref: 09/H1008/91).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	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 study start date	01/06/2009
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	150
Key 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.
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Lead Research Nurse

Liverpool
L8 7SS
United Kingdom

Sponsor information

Liverpool Women's Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Ms Gillian Vernon
Crown Street
Liverpool
L8 7SS
England
United Kingdom

Phone	+44 (0)151 7024346
Email	gillian.vernon@lwh.nhs.uk
Website	http://www.lwh.me.uk/
"ROR"	https://ror.org/04q5r0746

Funders

Funder type

Charity

BLISS (UK) - Innovations in Care Programme

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	10/06/2011		Yes	No
Results article	results	01/06/2013		Yes	No
Results article	results	01/01/2014		Yes	No
Results article	results	01/05/2015		Yes	No
HRA research summary			28/06/2023	No	No
Results article		10/11/2023	27/11/2023	Yes	No

Editorial Notes

27/11/2023: Publication reference added.