Standardised, Concentrated and Additional Macronutrients in neonatal Parenteral nutrition study
| ISRCTN | ISRCTN76597892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76597892 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | LWH 0776 |
| Sponsor | Liverpool Women's Hospital NHS Foundation Trust (UK) |
| Funder | BLISS (UK) - Innovations in Care Programme |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
|---|---|
| sarah.azurdia@lwh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase IV randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Neonatal parenteral nutrition formulation |
| 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). |
| Key secondary outcome measure(s) |
1. Weight gain and linear growth |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
L8 7SS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No | |
| Results article | results | 01/01/2014 | Yes | No | |
| Results article | results | 01/05/2015 | Yes | No | |
| Results article | 10/11/2023 | 27/11/2023 | Yes | No | |
| Protocol article | protocol | 10/06/2011 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2023: Publication reference added.
