Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Conditions: Neonatal Death, Prematurity
Sponsor: Imperial College London

 
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Outcomes following early parenteral nutrition use in very 
preterm neonates 
 
 
 
 
Version 1.0 
Date: 20/06/2018 
 
 
 
 
SPONSOR: Imperial College London 
FUNDER: Access to the NNRD through unrestricted funds awarded to Prof N Modi.  Data analysis 
funded within a Mason Medical Research Foundation fellowship awarded to Dr J Webbe. 
STUDY CO-ORDINATION: Section of Neonatal Medicine, Imperial College London,  
Chelsea and Westminster Hospital campus 
HRA REC Approval: 238670 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Group 
 
Chief Investigator: Dr Christopher Gale  
 
Co-investigators: Dr James Webbe, Dr Sabita Uthaya, Professor Neena Modi 
 
Statistician: Dr Nicholas Longford 
 
Data analyst: Kayleigh Ougham 
 
 
Parent representatives: Laura Noakes, Angela Richard-Löndt 
 
 
Sponsor 
 
Imperial College London; for further information regarding sponsorship conditions, 
please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
 
 
 
Should corrections or amendments be necessary to this protocol these will be 
circulated to all investigators. Queries relating to this study should be referred, in the 
first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance 
Framework for Health and Social Care (2nd edition). It will be conducted in 
compliance with the protocol, the Data Protection Act and other regulatory 
requirements as appropriate.  
 
 
 

 
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Table of Contents 
 
STUDY SUMMARY 
5 
PLAIN ENGLISH SUMMARY 
6 
1.  INTRODUCTION 
8 
1.1  
BACKGROUND 
8 
1.2  
RATIONALE FOR CURRENT STUDY 
8 
2. STUDY OBJECTIVES 
9 
3. RESEARCH QUESTIONS 
9 
4. STUDY DESIGN 
10 
4.1  
STUDY OUTCOME MEASURES 
10 
5. PARTICIPANT ENTRY 
11 
5.1  
INCLUSION CRITERIA 
11 
5.2  
EXCLUSION CRITERIA 
11 
5.1  
STUDY FLOW CHART 
11 
6. STATISTICS AND DATA ANALYSIS 
12 
6.1  
BACKGROUND VARIABLES TO BE USED FOR MATCHING 
12 
6.2  
STATISTICAL ANALYSIS 
14 
6.3  
SUBGROUP ANALYSIS 
14 
6.4  
SAMPLE SIZE CALCULATION 
14 
7. REGULATORY ISSUES 
15 
7.1  
ETHICS APPROVAL 
15 
7.2 
CONSENT 
15 
7.3 
DATA PROTECTION AND CONFIDENTIALITY 
15 
7.4 
INDEMNITY 
15 
7.5 
SPONSOR 
15 
7.6 
FUNDING 
15 
8. STUDY MANAGEMENT 
15 
9. PUBLICATION POLICY 
16 
10. REFERENCES 
17 
 
 
 

 
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GLOSSARY OF ABBREVIATIONS 
HRA 
Health Research Authority 
ICU 
Intensive care unit 
MRC 
Medical Research Council 
NHS 
National Health Service 
NICU 
Neonatal Intensive Care Unit 
NNAP 
National Neonatal Audit Project 
NNRD 
National Neonatal Research Database 
NDAU 
Neonatal Data Analysis Unit 
NICU 
Neonatal Intensive Care Unit 
PICU 
Paediatric Intensive Care Unit 
PN 
Parenteral nutrition 
 
 
 
 
 
 
 
 
 
 

 
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STUDY SUMMARY 
 
TITLE Outcomes following early parenteral nutrition (PN) use in 
very preterm neonates 
DESIGN Two components:  
A) Epidemiological survey of practice  
B) Retrospective cohort study. 
AIMS A)  To describe early PN use in neonatal units in England, 
Wales and Scotland. 
B) To identify whether the use of PN in the first seven 
postnatal days affects survival in neonates born between 30 
and 33 weeks postmenstrual age. 
To explore how PN use in the first seven postnatal days 
affects other important neonatal outcomes in neonates born 
between 30 and 33 weeks postmenstrual age. 
OUTCOME MEASURES A) Use of any PN during the first seven postnatal days. 
B) Primary outcomes: Survival to hospital discharge. 
Secondary outcomes: Sepsis, necrotising enterocolitis, brain 
injury, retinopathy of prematurity, need for surgical 
operation, seizures, growth, bronchopulmonary dysplasia, 
blindness, deafness and ability to walk. 
POPULATION A) All neonates born in England, Wales and Scotland and 
admitted to a NHS neonatal unit over the period 1st January 
2008 to 31st December 2017. 
B) All neonates born between 30and 33 weeks+days 
postmenstrual age in England, Wales and Scotland and 
admitted to a NHS neonatal unit between 1st January 2012 
and 31st December 2017. 
ELIGIBILITY A) All neonates admitted to a NHS neonatal unit (born 
between 23 and 42 weeks postmenstrual age). 
B) Neonates born between 30 and 33 weeks+days 
postmenstrual age who received PN in the first seven 
postnatal days.    
COMPARATORS A) No comparator group; descriptive study. 
B) Neonates born between 30+0 and 33 weeks+days 
postmenstrual age who received no PN in the first seven 
postnatal days. 
DATA SOURCE De-identified data held in the National Neonatal Research 
Database (NNRD) will be used. 
 
KEYWORDS 

 
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Parenteral nutrition, preterm, neonate, core outcomes set, NNRD, propensity score, 
neonatal care 
 

 
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PLAIN ENGLISH SUMMARY 
 
BACKGROUND 
Each year in the UK about 60,000 babies are born too early (before they have 
reached 37 weeks of pregnancy). Most premature babies need specialist care and 
often spend weeks or even months on a neonatal unit. 
 
An essential part of neonatal care is providing nutrition to ensure that babies grow 
and develop. Providing this can be difficult in premature babies because their 
intestines and other organs are underdeveloped. They often have difficulty digesting 
milk. Milk feeds are therefore introduced gradually. To help babies grow and develop 
during this period, additional nutrition may be provided as a fluid into a vein; this is 
called “parenteral nutrition” (PN).  Unfortunately, PN increases the risk of serious 
complications like bloodstream infection (also known as “sepsis”).   
 
There is general agreement that the benefits of PN outweigh the risks in babies who 
are extremely premature, i.e. those born more than 12 weeks early.  Babies born 
near term have adequate fat reserves and so are unlikely to benefit from PN.  For 
babies who are moderately premature there is little evidence to guide decision 
making about which babies will benefit from PN. This group of babies have more 
reserves of fat and are less dependent on PN, but are still at risk of sepsis.  This 
means the risks and benefits of PN are less clear.  As a consequence, some doctors 
use PN and others do not. The number of babies receiving PN across England, 
Scotland and Wales is unknown.    
 
AIMS 
Firstly, to describe which babies are given PN during the first postnatal week in 
neonatal units in England, Scotland and Wales. 
 
Secondly, to determine whether in babies born 7-10 weeks preterm (moderately 
premature), providing PN in the first week after birth, compared to not to providing 
PN, improves survival to discharge from the neonatal unit. 
 
Finally, to evaluate if the early use of PN in moderately preterm babies affects other 
important outcomes identified in related research called “Core Outcomes in 
Neonatology” where James Webbe obtained the views of over 250 former neonatal 
patients and parents (along with 150 nurses, doctors and researchers) to identify 
which outcomes they want neonatal research to focus on. 
 
IMPORTANCE 
This work will describe the extent of PN use in England, Scotland and Wales. This is 
currently unknown. This project will improve understanding of the balance of benefits 
and harms of PN use in premature babies and will help doctors and parents make 
informed treatment choices. My results will also inform future research to identify the 
best nutritional management for premature babies.    
 
METHODS 

 
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James Webbe will use the National Neonatal Research Database (NNRD) to study 
all babies born in England, Scotland and Wales that received NHS neonatal care 
over the period 2008-2017.  James Webbe will identify which babies were given PN 
during the first week, and which were not.   
James Webbe will use the NNRD to identify babies born 7-10 weeks prematurely.  
James Webbe will compare outcomes in babies that were given and not given PN in 
the first week after birth.    
 
The NNRD stores information from the electronic patient records (the computerised 
medical notes) of all babies born in England, Wales and Scotland who are admitted 
to a neonatal unit. All information held in the NNRD has had any identifying details 
removed, so no baby can be identified. James Webbe and Nick Longford will use 
statistical techniques to identify two sets of babies in the NNRD who are very similar 
(in terms of how prematurely they were born, their birth weight, sex, illness, and so 
on) with the only difference being in whether they were given PN or not. Neonatal 
Data Analysis Unit staff will then extract data from the NNRD about the outcomes 
(such as survival) and will compare the groups to see if there are any differences.  
As the two groups will be similar any difference in their outcomes is likely to be due 
to whether or not they received PN. 
 
BENEFITS 
The results of this research will help doctors make decisions and guide practice in an 
area in which there is currently very little evidence.  This work will provide more 
information about the balance of risks to benefits of PN use in premature babies.  
The results of this work will also inform future research to identify how best to ensure 
babies receive the nutrition they need.   
 
 
 
 

 
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1. 
INTRODUCTION  
 
1.1 
BACKGROUND 
Premature birth abruptly ends the transplacental transmission of nutrients that allows 
normal foetal growth and development.  Providing adequate nutrition is essential to 
allow premature babies to continue to grow and mature.  Very preterm infants often 
have difficulty tolerating adequate volumes of milk feeds shortly after birth due to the 
impaired mechanical and digestive function of their immature gut (1).To meet their 
nutritional needs they are given supplemental parenteral nutrition (PN).  Preterm 
babies are among the highest PN users of all NHS patients. In some units it has 
been estimated that PN is received by around 70% of neonatal admissions (2).  
However, how PN affects outcomes has never been tested in a large scale, 
randomized, placebo controlled neonatal trial. 
It is known that PN carries well established risks, of which the most serious and the 
most common is sepsis (3) with estimates of risk ratios varying from 2.2 to 14.6.  In 
addition there is a growing body of evidence that use of PN within the first seven 
days of admission to an intensive care unit is associated with worse outcomes in 
critically unwell adults (4) and children (5).  A subgroup analysis of the paediatric 
intensive care unit population focusing on neonates showed an increase in infections 
with early PN use (5).  This suggests that uncertainty exists over the benefit of giving 
neonates PN in the early postnatal period.  It is generally accepted that PN is 
beneficial to extremely preterm neonates, but in moderately preterm neonates the 
effect that PN use has on neonatal survival or other key outcomes has never been 
conclusively demonstrated (6-8). 
The uncertainty over how PN use affects neonatal outcomes is reflected by the wide 
variation in how PN is used in different units, where differences in use, timing and 
composition of PN (9, 10) are seen.  This is, in part, due to the lack of clear evidence 
of how PN affects neonatal outcomes like growth and survival.  Neonates are also 
vulnerable to unanticipated treatment effects across different organ systems (11), 
therefore it is important to show that PN, like other therapies, does not adversely 
impact any important neonatal outcomes. 
 
1.2 
RATIONALE FOR CURRENT STUDY 
The postmenstrual age at which the nutritional benefits of PN outweigh the risks in 
moderately preterm babies (30-33 weeks postmenstrual age) is unknown. It is 
therefore unsurprising that their nutritional management is very variable (9, 12-14).  
In moderately preterm neonates in 2012 and 2013 across England, Scotland and 
Wales PN was given to 45% of neonates, suggesting clinician equipoise around the 
balance of benefit to risk.  

 
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Identifying whether moderately preterm neonates benefit from PN would have 
important implications for practice in the UK, and will provide information to guide 
practice and inform future research.  
2.  STUDY OBJECTIVES 
 
• To describe the use of PN in neonatal units across England, Scotland and 
Wales. 
• To identify if use of PN in the first seven postnatal days affects survival in 
neonates born between 30 and 33 weeks postmenstrual age. 
• To explore how PN use in the first seven postnatal days affects other 
important neonatal outcomes in neonates born between 30 and 33 weeks 
postmenstrual age. 
 
3.  RESEARCH QUESTIONS 
 
A:  
Which neonates receive PN during the first postnatal week in neonatal units in 
England, Scotland and Wales? 
 
B:  
In preterm neonates born between 30 and 33 weeks postmenstrual age (Population) 
does administration of PN in the first seven postnatal days (Intervention) compared 
with no PN (Comparator) improve survival to discharge home (primary Outcome)? 
 
In preterm neonates born between 30 and 33 weeks postmenstrual age (Population) 
does administration of PN in the first seven postnatal days (Intervention) compared 
with no PN (Comparator) improve the outcomes in the core outcomes set for 
neonatology (secondary Outcomes)? 
 
 

 
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4.  STUDY DESIGN 
 
A: an epidemiological survey of practice using the National Neonatal Research 
Database (NNRD).   
B: a retrospective cohort study of matched groups of babies using data held in the 
NNRD.   
 
 
 
4.1 
STUDY OUTCOME MEASURES 
 
A: Primary outcome: any use of PN in the first seven postnatal days.   
 
B: Primary outcome: Survival to discharge home; defined as recorded as alive at 
final neonatal unit discharge. 
 
Secondary outcomes: other components of the neonatal core outcomes set (15).  
These include short term outcomes during the neonatal unit admission: 
• Late Onset Sepsis; defined in line with the Royal College of Paediatrics 
and Child Health National Neonatal Audit Programme (NNAP) definition  
“pure growth of a pathogen from blood” or “pure growth of a skin 
commensal” or a “mixed growth” after the first 72 hours of life (16) 
• Necrotising enterocolitis; defined using the NNAP definition (16) 
• Brain injury on imaging; defined as documented diagnosis of 
intraventricular haemorrhage (grade 3-4) (17) or cystic periventricular 
leucomalacia 
• Retinopathy of prematurity; defined as a record of any retinopathy of 
prematurity on routine screening in the National Neonatal Dataset 
“retinopathy of prematurity ad-hoc form” 
• Bronchopulmonary dysplasia; defined using the NNAP definition (16) of 
significant bronchopulmonary dysplasia. 
• Need for surgical procedures; defined as any record of surgical procedure 
during the neonatal admission 
• Seizures; defined as any recorded diagnosis of seizures or seizure 
disorder  
• Growth; weight and head circumference at discharge; weight velocity and 
head circumference velocity from birth to discharge  
Long term outcomes after discharge will also be measured: 
• Blindness; defined as an answer of Yes to the question “Does this child 
have a hearing impairment?” on the NNAP form (16) 
• Deafness; defined as an answer of Yes to the question “Does this child 
have a hearing impairment?” on the NNAP form (16) 
• Ability to walk; defined as an answer of Yes to the question “Is this child 
unable to walk without assistance?” on the NNAP form (16) 
 

 
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It will not be possible to measure the following components of the core outcomes set: 
quality of life, gross motor ability or cognitive ability as relevant data are not captured 
in the NNRD. 
 
5. 
PARTICIPANT ENTRY  
 
5.1 
INCLUSION CRITERIA 
 
A: Neonates born between 1st January 2008 and 31st December 2017 and admitted 
to a neonatal unit in England, Scotland and Wales).   
 
B: Neonates born between 30 and 33 weeks postmenstrual age between 1st 
January 2012 and 31st December 2017 and admitted to a neonatal unit in England, 
Scotland and Wales).   
 
 
5.2  
EXCLUSION CRITERIA 
 
A: No exclusions. 
 
B: Neonates with major congenital gastrointestinal malformations will be excluded as 
they cannot be fed enterally.  Neonates with life limiting conditions or conditions 
requiring surgery in the neonatal period will be excluded from the analysis as they 
will not receive standard neonatal nutritional care. Neonates with missing key 
background data (birthweight, sex or gestational age) or data for the primary 
outcome will be excluded. 
 
5.3  
STUDY FLOW CHART 
 
For Project B: 
 
 
Neonates with data stored within 
the NNRD  
(approximately 1,000,000) 
Final population 
(estimated 30,000) 
Inclusion criteria: 

Postmenstrual age at 
birth 30-33 weeks 
Exclusion criteria: 

Major congenital 
anomaly 

Missing principal 
background or outcome 
data 
Intervention group: 
Received parenteral nutrition in 
first week 
(45% estimated 13,500) 
Comparator group: 
Did not receive parenteral 
nutrition in first week 
(55% estimated 16,500) 

 
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6. 
DATA ANALYSIS 
 
A: James Webbe will extract data to identify the characteristics of neonates who 
receive PN in the first seven postnatal days.  Parenteral nutrition use will be 
described by gestational age, birth weight, over time and by geographical region. 
 
B: James Webbe and Nick Longford will use propensity matching within the potential 
outcomes framework to minimise bias and confounding. James Webbe and Nick 
Longford will ensure the two groups are as similar as possible (with the exception of 
the intervention; exposure to PN in the first week) by generating two matched 
cohorts for comparison.  
 
6.1 
BACKGROUND VARIABLES TO BE USED FOR MATCHING 
 
A: No matching necessary. 
 
B: Neonates will be matched on postmenstrual age at birth and low birth weight.  
Postmenstrual age will be matched by week.  Low birth weight will be treated as a 
dichotomous variable, with the threshold being the 10th centile for weight on the UK-
WHO growth chart (18).  These factors are likely to significantly affect both the 
decision to administer PN and eventual outcomes and so are potential sources of 
bias requiring additional matching. 
 
For postmenstrual age at birth neonates will be matched only with neonates born in 
the same postmenstrual week (i.e. a neonate born at 30+2 will be matched with a 
neonate born between 30+0 and 30+6).  For low birth weight neonates will be 
matched according to whether their weight at birth falls below the 9th centile for their 
sex and postmenstrual age (using WHO growth charts). 
 
In addition propensity score matching will be used for the following variables: 
 
• Demographic data items 
o Sex 
o Multiplicity 
o Year of birth 
• Maternal factors 
o Age 
o Gestational diabetes 
o Severe pre-eclampsia requiring pre-term birth 
o Severe pre-eclampsia 
o Gestational hypertension 
o Prolonged rupture of membranes (>24 hours) 
o Suspected chorioamnionitis 
o Receipt of antenatal steroids 
o Receipt of antenatal magnesium sulphate 
• Infant factors: Birth and Resuscitation 
o Apgar score at 5 minutes 

 
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o Chest compressions administered 
o Emergency resuscitation drugs administered 
o Intubated at resuscitation 
o Umbilical cord pH 
o Surfactant administered 
• Infant factors: condition on neonatal unit and initial treatment 
o Admission temperature 
o Admission mean blood pressure 
o Admission blood glucose 
o Admission heart rate 
o Admission oxygen saturation 
• Infant factors: first day care 
o Surfactant administered 
o Mechanical ventilation on Day 1 
o Inotropes administered on Day 1 
o Sepsis suspected on Day 1 
o Transfer on Day 1 
• Organisational factors 
o Level of initial neonatal unit  
o Neonatal network 
 
Factors occurring on the first day of admission to the neonatal unit will be matched 
as they will be independent of the administration of PN and will help to ensure the 
two cohorts are balanced. Factors occurring after the first day of admission will not 
be matched as they will not be independent of the administration of PN. 
 
Propensity score matching will allow causal inferences to be made from 
observational data by balancing potentially confounding factors (19).  Due to the 
large number of factors that need to be balanced the use of propensity score 
matching will allow matching to occur without the loss of a large number of 
observations.  Using the large population size and wide range of background data 
available in the NNRD will allow us to achieve well balanced cohorts; this will 
enhance the credibility of analysis. 
 
Cohorts balanced on all the background variables are formed by the following 
process.  Propensity scores (the probability of being assigned PN based on 
background variables) will be calculated using a logistic regression model.  Matched 
pairs (where one individual received PN and one did not) will be identified with 
similar propensity scores.  These matched pairs then form the two cohorts: treated 
with PN within the first week or not treated.  The balance on all background variables 
between these cohorts is assessed using a balance plot.  The logistic regression 
model is then refined (for example by the addition of further variables) and a new 
balance plot constructed.  This process is repeated until no further improvement in 
balance can be achieved.  This ensures that the propensity scores have been 
adequately specified to identify balanced groups (20).   
 
 

 
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6.2 
STATISTICAL ANALYSIS 
 
A: Rates of early PN use will be calculated from population level data. James Webbe 
will compare PN use in neonates born at different postmenstrual ages and different 
birth weights (using the WHO classification) (21).  Rates of PN use will be compared 
between different groups using the Chi-squared test. 
 
B: Absolute risk differences and odds ratios for the pre-specified, dichotomous 
outcomes will be calculated.  All p values calculated will be two-sided.  When 
analysing the secondary outcomes due to the risk of multiple comparisons to avoid 
erroneous inferences the Holm-Bonferroni method (22) will be used. 
 
6.3 
SUBGROUP ANALYSES 
 
A:  James Webbe will compare PN use at neonatal network level.  James Webbe 
will also compare how PN use has changed over the 5 year period in the different 
gestational age and birthweight groups using analysis of variance testing. 
 
B: James Webbe will undertake a planned sensitivity analysis to explore the 
possibility that a missing binary variable explains the effect size seen.  James 
Webbe will construct a dichotomous variable intended to stack the odds against the 
superior treatment option and then compare this to the background variables to 
explore whether it is plausible that such a “missing” variable exists. 
 
6.4 
SAMPLE SIZE 
 
A: Around 90,000 neonates are admitted to neonatal units in England, Scotland and 
Wales each year.  Since 2008 the NNRD holds data on approximately 1,000,000 
babies. 
 
B: James Webbe has calculated that 12,000 neonates are required in each group 
(PN and No PN) in order to have 90% power to detect (with two-sided significance of 
5%) an absolute difference in survival to discharge of 1.3% between the two groups.  
Pilot data suggests that over the five year period James Webbe will have 13,500 
neonates in the PN group and 16,500 in the No PN group. 
 
The absolute difference expected is calculated using the mortality rate of 3.4% for 
this group (23) and the odds ratio of 0.73 for early vs. late PN suggested by previous 
research (5). Pilot data suggests around 6,000 neonates each year are born 
between 30 weeks and 33 weeks postmenstrual age. 
 
 
 

 
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7. 
REGULATORY ISSUES 
 
7.1 
RESEARCH ETHICS APPROVAL 
 
The Neonatal Data Analysis Unit (NDAU) holds UK Research Ethics Committee 
approval (16/LO/1093), and Confidential Advisory Group approval (ECC 8-
05(f/2010)), to form the NNRD.  James Webbe will seek stand alone approval from 
the national research ethics service for this project.  As this study has no material 
ethical issues with minimal risk, burden or intrusion for research participants James 
Webbe will seek proportionate review. The Chief Investigator has obtained approval 
from the HRA. The Chief Investigator will require a copy of the Trust Capacity and 
Capability approval email  before accepting participants into the study.  The study 
will be conducted in accordance with the recommendations for physicians involved in 
research on human subjects adopted by the 18th World Medical Assembly, Helsinki 
1964 and later revisions. 
 
7.2 
CONSENT  
 
No patient consent is required as only de-identified data from the NNRD will be used. 
 
7.3 
DATA PROTECTION AND CONFIDENTIALITY 
 
All investigators and study site staff will comply with the requirements of the Data 
Protection Act and the General Data Protection Regulation 2018 with regards to the 
collection, storage, processing and disclosure of personal information and will uphold 
the Regulation’s core principles. Only de-identified data will be used in this study.  
Imperial College will collect information for this research study from the Neonatal 
Data Analysis Unit. The Neonatal Data Analysis Unit will not provide any identifying 
information to Imperial College. We will use this information to complete the 
described research.   
As no patient identifiable data will be used HRA Confidentiality Advisory Group 
approval is not required.  
 
Data from the NNRD will be extracted by staff from the Neonatal Data Analysis Unit 
operating within the guidelines established by Research Ethics Committee approval 
(REC Reference: 16/LO/1093) and Confidentiality Advisory Group approval (CAG 
reference: ECC 8-05(f)2010). No member of the study team will have access to 
identifiable data on any study participant: they are not part of the clinical care team. 
Data for this work will be extracted from the NNRD. The NNRD is an established 
research database and holds National Research Ethics Service approval 
(16/LO/1093). Data held within the NNRD will be retained as a research database. A 
copy of the study data extract will be retained by the NNRD as part of the research 
database. 
 
All data will be stored on a password secured computer in the Clinical Research 
Fellows’ office on the Chelsea and Westminster Hospital campus of Imperial College 
London.  All data will be stored for 10 years in line with institutional policy.   
 

 
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7.4 
INDEMNITY 
 
Imperial College London holds negligent harm and non-negligent harm insurance 
policies which apply to this study. 
 
7.5 
SPONSOR 
 
Imperial College London  
 
7.6 
FUNDING 
 
The funding for creating and maintaining the NNRD is from unrestricted funding 
awarded to Prof Neena Modi.  This funding includes costs involved in data transfer, 
storage, cleaning, merging, administration and regulatory approvals.   The extraction 
of study data from the NNRD and analysis of data for this study is funded through a 
Mason Medical Research Fellowship awarded to Dr James Webbe. 
 
7.7 
DATA STORAGE 
 
All data will be stored on a password secured computer in the Clinical Research 
Fellow’s Office on the Chelsea and Westminster Hospital campus of Imperial College 
London.  All data will be stored for ten years.  All anonymised data can be accessed 
by contacting the primary investigator. 
 
8. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through the Section of 
Neonatal Medicine at Imperial College London.  Monitoring and auditing research 
conduct will be performed by the sponsor as required and according to the 
sponsor's standard operating procedure. 
 
9. 
PUBLICATION POLICY 
 
The results of this study will be reported as a manuscript in a peer-reviewed scientific 
journal.  All members of the study group will be authors with additional contributors 
as appropriate. JW will be first author, CG will be last author. 
 
 
 

 
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10. 
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2. 
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2007;27(5):284-90. Epub 2007/03/09. 
3. 
Zingg W, Tomaske M, Martin M. Risk of parenteral nutrition in neonates--an 
overview. Nutrients. 2012;4(10):1490-503. Epub 2012/12/04. 
4. 
Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, et al. 
Early versus late parenteral nutrition in critically ill adults. The New England journal of 
medicine. 2011;365(6):506-17. Epub 2011/07/01. 
5. 
Fivez T, Kerklaan D, Mesotten D, Verbruggen S, Wouters PJ, Vanhorebeek I, et al. 
Early versus Late Parenteral Nutrition in Critically Ill Children. The New England journal of 
medicine. 2016;374(12):1111-22. Epub 2016/03/16. 
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