Infant, NewbornNCT03278847
Optimising Newborn Nutrition During Therapeutic Hypothermia.
An observational study of Infant, Newborn and Asphyxia Neonatorum, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia. To do this the investigators will perform two primary comparisons: 1. Read more about this study
- Who is it for?
- Ages Up to 4 days
- Conditions the study is for
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced
- What is being tested?
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia and Received parenteral nutrition during therapeutic hypothermia
- Type of treatment
- Injection or infusion
- How many people
- 6,030 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jan 2010to 1 Jan 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 4 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants born at 36 gestational weeks or later who received therapeutic hypothermia for Hypoxic Ischaemic Encephalopathy (HIE) for least 72 hours, or who died during therapeutic hypothermia.
Who may be able to join
- Received neonatal care at a unit that is part of the UK Neonatal Collaborative; this includes all NHS neonatal units in England, Scotland and Wales
- Recorded gestational age at birth ≥36 weeks
- Recorded as receiving therapeutic hypothermia for 72 hours or died during therapeutic hypothermia
Who cannot join
- 1. Infants with missing data for principal background and outcome variables.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Chelsea and Westminster Hospital and NHS Foundation Trust
London, SW10 9NH
Imperial College London, Chelsea and Westminster Hospital campus
London, SW10 9NH
About this study
Official title: Optimising Newborn Nutrition During Therapeutic Hypothermia: an Observational Study Using Routinely Collected Data
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia. To do this the investigators will perform two primary comparisons:
- ENTERAL: to determine whether any enteral (milk) feeding, when compared to withholding enteral feeding (no milk), during therapeutic hypothermia, is associated with a difference in the incidence of necrotising enterocolitis.
- PARENTERAL: to determine whether provision of intravenous dextrose, when compared to provision of parenteral nutrition, during therapeutic hypothermia, is associated with a difference in the incidence of blood stream infection.
The investigators will use de-identified data held in an established research database called the National Neonatal Research Database (NNRD) and we will use the potential outcomes framework with application of propensity scoring to define matched subgroups for comparison.
Read the detailed description
Every year about 1200 babies in England, Wales and Scotland suffer from a lack of oxygen around birth which can lead to long-term brain injury or death. This is called Hypoxic Ischaemic Encephalopathy (HIE). Research has shown that cooling babies with HIE by a few degrees for the first 3 days protects the brain; all babies with moderate or severe HIE in the UK are treated with therapeutic hypothermia (cooling).
Doctors do not know how best to care for babies while they are cooled. A key question is "how to provide nutrition to babies during cooling". There are two main parts to this question, milk feeds ("enteral" nutrition) and intravenous nutrition ("parenteral" nutrition). Doctors don't know how best to provide either milk or intravenous nutrition to cooled babies.
- MILK FEEDS: Some neonatal units in the UK carefully feed babies (usually with maternal breast milk) while they are cooled. This avoids intravenous lines and is believed to help them feed and go home earlier. Other neonatal units do not feed cooled babies because they worry about a condition called necrotising enterocolitis (a devastating and often fatal disease) which might be more common with feeding.
- INTRAVENOUS NUTRITION: All cooled babies need intravenous fluid (even when milk feeds are given it takes several days before enough fluid can be given this way). Some neonatal units give babies intravenous nutrition (which contains fat, protein, carbohydrate, vitamins and minerals) as this may improve growth and recovery. Other neonatal units only give intravenous dextrose with simple salts because of concerns that intravenous nutrition leads to more infections. This study will compare these different ways of providing nutrition. It will use a research database called the National Neonatal Research Database (NNRD). In England, Scotland and Wales doctors and nurses looking after babies in neonatal care (including all cooled babies) use an Electronic Health Record system. Data from this system are anonymised (no baby can be identified) and form the NNRD, so the NNRD holds data from all babies who have been looked after on NHS neonatal units.
The investigators have worked closely with parents and charities in developing the NNRD. The investigators will use the NNRD to study all term babies who received cooling in England, Scotland and Wales since 2008. The investigators will compare the milk feeding and intravenous nutrition they receive.
- MILK FEEDING: The investigators will compare babies who are fed milk while cooled with those that are not fed any milk. The investigator's main goal is to establish whether there is any difference in rates of necrotising enterocolitis.
- INTRAVENOUS NUTRITION: The investigators will compare babies who get intravenous nutrition with those that only get intravenous dextrose. The main difference we are looking for is in the rate of infection. The investigators will also study how many babies die, how long they stay in neonatal care, how soon breastfeeding starts and many are breastfed when they go home.
The investigators will apply a statistical approach called "potential outcomes framework" in which babies are matched in each group (e.g. babies who are fed and those who are not fed) as closely as possible. This will ensure that any difference in outcomes is due to the different nutritional treatments and not due to background differences or other confounders (like how sick a baby is).
The results from this study will help to ensure that babies who need to be cooled for HIE receive the best and safest nutrition in the future.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition, Infant Nutrition, Necrotizing Enterocolitis
- Being tested
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia, Did not receive parenteral nutrition during therapeutic hypothermia
- Keywords
- NNRD, matching, propensity score
- Medical subject headings
- Asphyxia Neonatorum, Hypothermia, Hyperphagia, Enterocolitis, Necrotizing, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Received enteral (milk) feeds during therapeutic hypothermiaDietary supplement
In the enteral component of nutrition, the health technology to be assessed is the gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
- Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
- This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
- This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
Enteral (milk) feeds withheld during therapeutic hypothermiaDietary supplement
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
Received parenteral nutrition during therapeutic hypothermiaDietary supplement
In the parenteral component, the health technology being assessed is administration of parenteral nutrition during therapeutic hypothermia:
- Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
- This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
- This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
Did not receive parenteral nutrition during therapeutic hypothermiaDietary supplement
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrition comparison | This comparison refers to differences in enteral nutrition during therapeutic hypothermia Receives: Dietary Supplement: Received enteral (milk) feeds during therapeutic hypothermia; Dietary Supplement: Enteral (milk) feeds withheld during therapeutic hypothermia | |
| Parenteral nutrition comparison | This comparison refers to differences in parenteral nutrition during therapeutic hypothermia Receives: Dietary Supplement: Received parenteral nutrition during therapeutic hypothermia; Dietary Supplement: Did not receive parenteral nutrition during therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necrotising Enterocolitis - for the Enteral Nutrition Comparison
Defined according to the case definition of Battersby et al., 2017, JAMA Pediatrics
Measured: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Blood Stream Infection - for the Parenteral Nutrition Comparison
defined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition: pure growth of a recognised pathogen from a normally sterile site
Measured: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Secondary outcomes (6)
Survival
Survival at neonatal unit discharge
Measured: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Length of Stay
Number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants
Measured: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Breastfeeding
Any breastfeeding (suckling at the breast) at discharge
Measured: At the point of final discharge from neonatal care, assessed up to 1 year
Hypoglycaemia
Any diagnosis of hypoglycaemia recorded after therapeutic hypothermia is commenced and before the final neonatal unit discharge
Measured: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Duration of Central Venous Line
The number of days until an infant is recorded as not having a central venous line
Measured: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Growth
Weight for post-menstrual age standard deviation score at final neonatal unit discharge.
Standard deviation score, higher score means higher growth (higher weight for gestational age)
Measured: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jan 2010
- Primary completion31 Dec 2017
- Study completion1 Jan 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 (4)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies 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
- 6,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Bliss Charity
- Responsible party
- Sponsor
- Investigators
- Chris Gale, MBBS, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278847
- Sponsor's protocol ID
- 17IC4064
- Other IDs
- 16/79/03, 17/EM/0307
- Status last verified
- Nov 2022
- First submitted
- 23 Aug 2017
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study data will be extracted from the National Neonatal Research Database (NNRD). The NNRD has been created through the collaborative efforts of neonatal services across the country to be a national resource. The NNRD is maintained and managed at the Neonatal Data Analysis Unit (NDAU) at Imperial College London and Chelsea and Westminster NHS Foundation Trust. Researchers, clinicians, managers, commissioners, and others are welcome and encouraged to utilise the NNRD.
Publications
Battersby C, Longford N, Patel M, Selby E, Ojha S, Dorling J, Gale C. Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching. BMJ Open. 2018 Oct 23;8(10):e026739. doi: 10.1136/bmjopen-2018-026739.
PubMed 30355795Gale C, Jeyakumaran D, Longford N, Battersby C, Ojha S, Oughham K, Dorling J. Administration of parenteral nutrition during therapeutic hypothermia: a population level observational study using routinely collected data held in the National Neonatal Research Database. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):608-613. doi: 10.1136/archdischild-2020-321299. Epub 2021 May 5.
PubMed 33952628Gale C, Longford NT, Jeyakumaran D, Ougham K, Battersby C, Ojha S, Dorling J. Feeding during neonatal therapeutic hypothermia, assessed using routinely collected National Neonatal Research Database data: a retrospective, UK population-based cohort study. Lancet Child Adolesc Health. 2021 Jun;5(6):408-416. doi: 10.1016/S2352-4642(21)00026-2. Epub 2021 Apr 21.
PubMed 33891879Gale C, Jeyakumaran D, Battersby C, Ougham K, Ojha S, Culshaw L, Selby E, Dorling J, Longford N. Nutritional management in newborn babies receiving therapeutic hypothermia: two retrospective observational studies using propensity score matching. Health Technol Assess. 2021 Jun;25(36):1-106. doi: 10.3310/hta25360.
PubMed 34096500
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Newborn Nutrition During Therapeutic Hypothermia: an Observational Study Using Routinely Collected Data
- ClinicalTrials.gov ID
- NCT03278847
- Acronym / sponsor ID
- 17IC4064
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition, Infant Nutrition, Necrotizing Enterocolitis
- Keywords
- NNRD, matching, propensity score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,030 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Nottingham, Bliss Charity
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia. To do this the investigators will perform two primary comparisons:
- ENTERAL: to determine whether any enteral (milk) feeding, when compared to withholding enteral feeding (no milk), during therapeutic hypothermia, is associated with a difference in the incidence of necrotising enterocolitis.
- PARENTERAL: to determine whether provision of intravenous dextrose, when compared to provision of parenteral nutrition, during therapeutic hypothermia, is associated with a difference in the incidence of blood stream infection.
The investigators will use de-identified data held in an established research database called the National Neonatal Research Database (NNRD) and we will use the potential outcomes framework with application of propensity scoring to define matched subgroups for comparison.
Detailed description
Every year about 1200 babies in England, Wales and Scotland suffer from a lack of oxygen around birth which can lead to long-term brain injury or death. This is called Hypoxic Ischaemic Encephalopathy (HIE). Research has shown that cooling babies with HIE by a few degrees for the first 3 days protects the brain; all babies with moderate or severe HIE in the UK are treated with therapeutic hypothermia (cooling).
Doctors do not know how best to care for babies while they are cooled. A key question is "how to provide nutrition to babies during cooling". There are two main parts to this question, milk feeds ("enteral" nutrition) and intravenous nutrition ("parenteral" nutrition). Doctors don't know how best to provide either milk or intravenous nutrition to cooled babies.
- MILK FEEDS: Some neonatal units in the UK carefully feed babies (usually with maternal breast milk) while they are cooled. This avoids intravenous lines and is believed to help them feed and go home earlier. Other neonatal units do not feed cooled babies because they worry about a condition called necrotising enterocolitis (a devastating and often fatal disease) which might be more common with feeding.
- INTRAVENOUS NUTRITION: All cooled babies need intravenous fluid (even when milk feeds are given it takes several days before enough fluid can be given this way). Some neonatal units give babies intravenous nutrition (which contains fat, protein, carbohydrate, vitamins and minerals) as this may improve growth and recovery. Other neonatal units only give intravenous dextrose with simple salts because of concerns that intravenous nutrition leads to more infections. This study will compare these different ways of providing nutrition. It will use a research database called the National Neonatal Research Database (NNRD). In England, Scotland and Wales doctors and nurses looking after babies in neonatal care (including all cooled babies) use an Electronic Health Record system. Data from this system are anonymised (no baby can be identified) and form the NNRD, so the NNRD holds data from all babies who have been looked after on NHS neonatal units.
The investigators have worked closely with parents and charities in developing the NNRD. The investigators will use the NNRD to study all term babies who received cooling in England, Scotland and Wales since 2008. The investigators will compare the milk feeding and intravenous nutrition they receive.
- MILK FEEDING: The investigators will compare babies who are fed milk while cooled with those that are not fed any milk. The investigator's main goal is to establish whether there is any difference in rates of necrotising enterocolitis.
- INTRAVENOUS NUTRITION: The investigators will compare babies who get intravenous nutrition with those that only get intravenous dextrose. The main difference we are looking for is in the rate of infection. The investigators will also study how many babies die, how long they stay in neonatal care, how soon breastfeeding starts and many are breastfed when they go home.
The investigators will apply a statistical approach called "potential outcomes framework" in which babies are matched in each group (e.g. babies who are fed and those who are not fed) as closely as possible. This will ensure that any difference in outcomes is due to the different nutritional treatments and not due to background differences or other confounders (like how sick a baby is).
The results from this study will help to ensure that babies who need to be cooled for HIE receive the best and safest nutrition in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition comparison | – | Dietary Supplement: Received enteral (milk) feeds during therapeutic hypothermia, Dietary Supplement: Enteral (milk) feeds withheld during therapeutic hypothermiaThis comparison refers to differences in enteral nutrition during therapeutic hypothermia |
| Parenteral nutrition comparison | – | Dietary Supplement: Received parenteral nutrition during therapeutic hypothermia, Dietary Supplement: Did not receive parenteral nutrition during therapeutic hypothermiaThis comparison refers to differences in parenteral nutrition during therapeutic hypothermia |
Who may qualify
- Ages
- Up to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born at 36 gestational weeks or later who received therapeutic hypothermia for Hypoxic Ischaemic Encephalopathy (HIE) for least 72 hours, or who died during therapeutic hypothermia.
Key inclusion criteria (3 listed)
- Received neonatal care at a unit that is part of the UK Neonatal Collaborative; this includes all NHS neonatal units in England, Scotland and Wales
- Recorded gestational age at birth ≥36 weeks
- Recorded as receiving therapeutic hypothermia for 72 hours or died during therapeutic hypothermia
Key exclusion criteria (1 listed)
- 1. Infants with missing data for principal background and outcome variables.
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 |
|---|---|---|
| Received enteral (milk) feeds during therapeutic hypothermiaIn the enteral component of nutrition, the health technology to be assessed is the gradual introduction of enteral (milk) feeds during therapeutic hypothermia: * Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula) * This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle * This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster) | Dietary supplement | Enteral nutrition comparison |
| Enteral (milk) feeds withheld during therapeutic hypothermiaWithholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia. | Dietary supplement | Enteral nutrition comparison |
| Received parenteral nutrition during therapeutic hypothermiaIn the parenteral component, the health technology being assessed is administration of parenteral nutrition during therapeutic hypothermia: * Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition) * This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter. * This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater). | Dietary supplement | Parenteral nutrition comparison |
| Did not receive parenteral nutrition during therapeutic hypothermiaReceived standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia. | Dietary supplement | Parenteral nutrition comparison |
Primary outcome
Necrotising Enterocolitis - for the Enteral Nutrition Comparison
Time frame: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Defined according to the case definition of Battersby et al., 2017, JAMA Pediatrics
Blood Stream Infection - for the Parenteral Nutrition Comparison
Time frame: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
defined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition: pure growth of a recognised pathogen from a normally sterile site
6 secondary outcomes
Survival
Time frame: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Length of Stay
Time frame: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Breastfeeding
Time frame: At the point of final discharge from neonatal care, assessed up to 1 year
Hypoglycaemia
Time frame: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Duration of Central Venous Line
Time frame: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Growth
Time frame: From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30355795Battersby C, Longford N, Patel M, Selby E, Ojha S, Dorling J, Gale C. Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching. BMJ Open. 2018 Oct 23;8(10):e026739. doi: 10.1136/bmjopen-2018-026739.
- Background: PubMed 33952628Gale C, Jeyakumaran D, Longford N, Battersby C, Ojha S, Oughham K, Dorling J. Administration of parenteral nutrition during therapeutic hypothermia: a population level observational study using routinely collected data held in the National Neonatal Research Database. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):608-613. doi: 10.1136/archdischild-2020-321299. Epub 2021 May 5.
- Results publication: PubMed 33891879Gale C, Longford NT, Jeyakumaran D, Ougham K, Battersby C, Ojha S, Dorling J. Feeding during neonatal therapeutic hypothermia, assessed using routinely collected National Neonatal Research Database data: a retrospective, UK population-based cohort study. Lancet Child Adolesc Health. 2021 Jun;5(6):408-416. doi: 10.1016/S2352-4642(21)00026-2. Epub 2021 Apr 21.
- Results publication: PubMed 34096500Gale C, Jeyakumaran D, Battersby C, Ougham K, Ojha S, Culshaw L, Selby E, Dorling J, Longford N. Nutritional management in newborn babies receiving therapeutic hypothermia: two retrospective observational studies using propensity score matching. Health Technol Assess. 2021 Jun;25(36):1-106. doi: 10.3310/hta25360.
- Individual participant dataSharing planned: Yes. All study data will be extracted from the National Neonatal Research Database (NNRD). The NNRD has been created through the collaborative efforts of neonatal services across the country to be a national resource. The NNRD is maintained and managed at the Neonatal Data Analysis Unit (NDAU) at Imperial College London and Chelsea and Westminster NHS Foundation Trust. Researchers, clinicians, managers, commissioners, and others are welcome and encouraged to utilise the NNRD.
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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 Gale, MBBS, PhD principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Newborn and Asphyxia Neonatorum, run by Imperial College London at 2 sites 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 3 inclusion and 1 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 14 Sep 2023). 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?
Necrotising Enterocolitis - for the Enteral Nutrition Comparison (time frame: From date of birth until date of final neonatal unit discharge, 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 NCT03278847, which also lists 4 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 14 Sep 2023.