Neonatal DeathNCT03767634
Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
An observational study of Neonatal Death and Prematurity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
BACKGROUND 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 are underdeveloped. They often have difficulty digesting milk so feeds are introduced gradually. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Death, Prematurity
- What is being tested?
- Parenteral nutrition
- Type of treatment
- Injection or infusion
- How many people
- 97,507 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 1 Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England, Scotland and Wales).
Who may be able to join
- Project A:
- Must be born between 1st January 2012 and 31st December 2017
- Must be admitted to a National Health Service (NHS) neonatal unit in England, Scotland or Wales
- Project B:
- Must be born between 30 and 33 weeks postmenstrual age
- Must be born between 1st January 2012 and 31st December 2017
- Must be admitted to an NHS neonatal unit in England, Scotland or Wales
Who cannot join
- Project A:
- No exclusion criteria.
- Project B:
- Major congenital gastrointestinal malformations
- Life limiting conditions
- Congenital conditions requiring surgery in the neonatal period
- Missing key background data (birthweight, sex or gestational age)
- Missing data for the primary outcome
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND
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 are underdeveloped. They often have difficulty digesting milk so feeds are 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"). 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. As a consequence, some doctors use PN and others do not.
Read more
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 in the neonatal core outcomes set.
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.
METHODS
The investigators will use the National Neonatal Research Database (NNRD) to study all babies born in England, Scotland and Wales; they will identify which babies were given PN during the first week, and which were not. The investigators will use the NNRD to identify babies born 7-10 weeks prematurely and compare outcomes in babies that were given and not given PN in the first week after birth. The investigators 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, and so on), the only difference being whether they were given PN or not. As the two groups will be similar any difference in their outcomes (such as survival) is likely to be due to whether or not they received PN.
Read the detailed description
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 and so are given supplemental parenteral nutrition (PN). Preterm babies are among the highest PN users of all NHS patients. It has been estimated that PN is received by around 70% of neonatal unit admissions but it is not known exactly which babies receive PN. In addition, 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 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 and children. A subgroup analysis of the paediatric intensive care unit population focusing on neonates showed an increase in infections with early PN use. 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 has never been conclusively demonstrated.
The uncertainty over how PN use affects neonatal outcomes is reflected by the wide variety in how PN is used in different units with large variation in use, timing and composition of PN. 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 which can occur in different organ systems and so it is important to show that PN is not detrimental to important neonatal outcomes.
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. 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. Identifying whether moderately preterm neonates benefit from PN would have important implications for practice in the UK. This work will provide information to guide practice and inform future research.
In summary, PN is widely used in neonates but it is not known exactly how it is used in the UK. It is known to have risks and benefits but there is insufficient evidence to guide practice in moderately preterm neonates.
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.
Study design:
Project A: an epidemiological survey of practice using the National Neonatal Research Database (NNRD).
Project B: a retrospective cohort study of matched groups of babies using data held in the NNRD.
- Conditions
- Neonatal Death, Prematurity
- Being tested
- Parenteral nutrition
- Keywords
- Preterm neonate, Parenteral nutrition
- Medical subject headings
- Perinatal Death, Premature Birth, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutritionOther
Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal population (Project A) | Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England, Scotland and Wales). | |
| No PN use (Project B) | All neonates born between 30 and 33 weeks postmenstrual age in England, Wales and Scotland and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days. | |
| PN use (Project B) | All neonates born between 30 and 33 weeks postmenstrual age in England, Wales and Scotland and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days. Receives: Other: Parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Parenteral Nutrition (Project A)
Any use of parenteral nutrition in the first seven days of postnatal life (assessed using daily data extracted from the National Neonatal Research Database as described in the project protocol)
This outcome formed part of Project A ONLY, and in keeping with the research protocol is only analysed and reported for the babies in this research arm.
Measured: From birth until discharge home, assessed up to 1 year
Survival to Discharge Home (Project B)
Defined as recorded alive at final neonatal unit discharge
This outcome formed part of Project B ONLY, and in keeping with the research protocol is only analysed and reported for the babies in this research arm.
Measured: From birth until discharge home, assessed up to 1 year
Secondary outcomes (12)
Late Onset Sepsis (Project B)
Number of participants with diagnosed Later 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
Measured: 72 hours of postnatal life to discharge home, assessed up to 1 year
Necrotising Enterocolitis (Project B)
Number of participants with diagnosed necrotising enterocolitis: defined using the NNAP definition: NEC may be diagnosed at surgery, post-mortem or on the basis of the following clinical and radiographic signs:
At least one clinical feature from:
(i) Bilious gastric aspirate or emesis (ii) Abdominal distension (iii) Occult or gross blood in stool (no fissure)
And at least one radiographic feature from:
(i) Pneumatosis (ii) Hepato-biliary gas (iii) Pneumoperitoneum
Measured: From birth until discharge home, assessed up to 1 year
Brain Injury on Imaging (Project B)
Number of participants with diagnosed brain injury on imaging: defined as documented diagnosis of intraventricular haemorrhage (grade 3-4) or cystic periventricular leucomalacia
Measured: From birth until discharge home, assessed up to 1 year
Retinopathy of Prematurity (Project B)
Number of participants with diagnosed 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"
Measured: From birth until discharge home, assessed up to 1 year
Bronchopulmonary Dysplasia (Project B)
Number of participants with diagnosed bronchopulmonary dysplasia: defined using the NNAP definition of significant bronchopulmonary dysplasia: Receiving respiratory support at 36 weeks corrected gestational age.
Measured: From birth until discharge home, assessed up to 1 year
Need for Surgical Procedures (Project B)
Defined as any record of surgical procedure during the neonatal admission
Measured: From birth until discharge home, assessed up to 1 year
Seizures (Project B)
Number of participants diagnosed as having a seizure: defined as any recorded diagnosis of seizures or seizure disorder
Measured: From birth until discharge home, assessed up to 1 year
Weight (Project B)
Weight z-score at discharge home. Weights at discharge home were converted to a z-score: a z-score of 0 represents the population mean, while score higher scores indicate a greater weight.
Measured: From birth until discharge home, assessed up to 1 year
Head Circumference (Project B)
Head circumference in centimetres at discharge; head circumference velocity (measured as increase in head circumference in centimetres/day) from birth until discharge
Measured: From birth until discharge home, assessed up to 1 year
Blindness (Project B)
Defined as an answer of Yes to the question "Does this child have a visual impairment?" on the NNAP follow up form
Measured: From birth until two years of age
Deafness (Project B)
Defined as an answer of Yes to the question "Does this child have a hearing impairment?" on the NNAP follow up form
Measured: From birth until two years of age
Ability to Walk (Project B)
Defined as an answer of Yes to the question "Is this child unable to walk without assistance?" on the NNAP follow up form
Measured: From birth until two years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal DeathStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris RK Gale, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767634
- Sponsor's protocol ID
- 18IC4724
- Status last verified
- Jan 2022
- First submitted
- 30 Nov 2018
- Last updated
- 17 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Webbe J, Battersby C, Longford N, Oughham K, Uthaya S, Modi N, Gale C. Use of parenteral nutrition in the first postnatal week in England and Wales: an observational study using real-world data. BMJ Paediatr Open. 2022 Aug;6(1):e001543. doi: 10.1136/bmjpo-2022-001543.
PubMed 36053624Webbe JWH, Longford N, Battersby C, Oughham K, Uthaya SN, Modi N, Gale C. Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks' gestation: a propensity score matched observational study. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):131-136. doi: 10.1136/archdischild-2021-321643. Epub 2021 Sep 21.
PubMed 34548324Webbe J, Longford N, Uthaya S, Modi N, Gale C. Outcomes following early parenteral nutrition use in preterm neonates: protocol for an observational study. BMJ Open. 2019 Jul 9;9(7):e029065. doi: 10.1136/bmjopen-2019-029065.
PubMed 31289090
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
- ClinicalTrials.gov ID
- NCT03767634
- Acronym / sponsor ID
- 18IC4724
- Conditions
- Neonatal Death, Prematurity
- Keywords
- Preterm neonate, Parenteral nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97,507 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Posted 17 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND
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 are underdeveloped. They often have difficulty digesting milk so feeds are 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"). 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. As a consequence, some doctors use PN and others do not.
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 in the neonatal core outcomes set.
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.
METHODS
The investigators will use the National Neonatal Research Database (NNRD) to study all babies born in England, Scotland and Wales; they will identify which babies were given PN during the first week, and which were not. The investigators will use the NNRD to identify babies born 7-10 weeks prematurely and compare outcomes in babies that were given and not given PN in the first week after birth. The investigators 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, and so on), the only difference being whether they were given PN or not. As the two groups will be similar any difference in their outcomes (such as survival) is likely to be due to whether or not they received PN.
Detailed description
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 and so are given supplemental parenteral nutrition (PN). Preterm babies are among the highest PN users of all NHS patients. It has been estimated that PN is received by around 70% of neonatal unit admissions but it is not known exactly which babies receive PN. In addition, 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 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 and children. A subgroup analysis of the paediatric intensive care unit population focusing on neonates showed an increase in infections with early PN use. 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 has never been conclusively demonstrated.
The uncertainty over how PN use affects neonatal outcomes is reflected by the wide variety in how PN is used in different units with large variation in use, timing and composition of PN. 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 which can occur in different organ systems and so it is important to show that PN is not detrimental to important neonatal outcomes.
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. 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. Identifying whether moderately preterm neonates benefit from PN would have important implications for practice in the UK. This work will provide information to guide practice and inform future research.
In summary, PN is widely used in neonates but it is not known exactly how it is used in the UK. It is known to have risks and benefits but there is insufficient evidence to guide practice in moderately preterm neonates.
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.
Study design:
Project A: an epidemiological survey of practice using the National Neonatal Research Database (NNRD).
Project B: a retrospective cohort study of matched groups of babies using data held in the NNRD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neonatal population (Project A) | – | –Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England, Scotland and Wales). |
| No PN use (Project B) | – | –All neonates born between 30 and 33 weeks postmenstrual age in England, Wales and Scotland and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days. |
| PN use (Project B) | – | Other: Parenteral nutritionAll neonates born between 30 and 33 weeks postmenstrual age in England, Wales and Scotland and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England, Scotland and Wales).
Key inclusion criteria (7 listed)
- Must be born between 1st January 2012 and 31st December 2017
- Must be admitted to a National Health Service (NHS) neonatal unit in England, Scotland or Wales
- Must be born between 30 and 33 weeks postmenstrual age
- Must be born between 1st January 2012 and 31st December 2017
- Must be admitted to an NHS neonatal unit in England, Scotland or Wales
Key exclusion criteria (8 listed)
- No exclusion criteria.
- Major congenital gastrointestinal malformations
- Life limiting conditions
- Congenital conditions requiring surgery in the neonatal period
- Missing key background data (birthweight, sex or gestational age)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral nutritionParenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support. | Other | PN use (Project B) |
Primary outcome
Use of Parenteral Nutrition (Project A)
Time frame: From birth until discharge home, assessed up to 1 year
Any use of parenteral nutrition in the first seven days of postnatal life (assessed using daily data extracted from the National Neonatal Research Database as described in the project protocol) This outcome formed part of Project A ONLY, and in keeping with the research protocol is only analysed and reported for the babies in this research arm.
Survival to Discharge Home (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Defined as recorded alive at final neonatal unit discharge This outcome formed part of Project B ONLY, and in keeping with the research protocol is only analysed and reported for the babies in this research arm.
12 secondary outcomes
Late Onset Sepsis (Project B)
Time frame: 72 hours of postnatal life to discharge home, assessed up to 1 year
Necrotising Enterocolitis (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Brain Injury on Imaging (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Retinopathy of Prematurity (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Bronchopulmonary Dysplasia (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Need for Surgical Procedures (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Seizures (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Weight (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Head Circumference (Project B)
Time frame: From birth until discharge home, assessed up to 1 year
Blindness (Project B)
Time frame: From birth until two years of age
Deafness (Project B)
Time frame: From birth until two years of age
Ability to Walk (Project B)
Time frame: From birth until two years of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36053624Webbe J, Battersby C, Longford N, Oughham K, Uthaya S, Modi N, Gale C. Use of parenteral nutrition in the first postnatal week in England and Wales: an observational study using real-world data. BMJ Paediatr Open. 2022 Aug;6(1):e001543. doi: 10.1136/bmjpo-2022-001543.
- Derived from this study: PubMed 34548324Webbe JWH, Longford N, Battersby C, Oughham K, Uthaya SN, Modi N, Gale C. Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks' gestation: a propensity score matched observational study. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):131-136. doi: 10.1136/archdischild-2021-321643. Epub 2021 Sep 21.
- Derived from this study: PubMed 31289090Webbe J, Longford N, Uthaya S, Modi N, Gale C. Outcomes following early parenteral nutrition use in preterm neonates: protocol for an observational study. BMJ Open. 2019 Jul 9;9(7):e029065. doi: 10.1136/bmjopen-2019-029065.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris RK Gale, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Death and Prematurity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Parenteral Nutrition (Project A) (time frame: From birth until discharge home, assessed up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767634, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.