Early antibiotic use and intestinal disease (necrotising enterocolitis) in premature babies
ISRCTN | ISRCTN55101779 |
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DOI | https://doi.org/10.1186/ISRCTN55101779 |
IRAS number | 312574 |
Secondary identifying numbers | IRAS 312574 |
- Submission date
- 09/06/2022
- Registration date
- 13/07/2022
- Last edited
- 07/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Necrotising enterocolitis (NEC) is a key cause of death and disease in preterm infants. Early antibiotic use has been shown to impact on rates of NEC, with data suggesting that receipt in the first days after birth is protective, but long duration has adverse impact on NEC rates. We aim to use the large UK dataset of preterm births known as The National Neonatal Research Database (NNRD) to further delineate this relationship. The NNRD holds data on 'every' preterm neonate admitted in the United Kingdom in a link anonymised fashion, allowing exploration of the role of antibiotics in NEC development in a much bigger population than previously explored.
Who can participate?
Premature babies born at <32 weeks gestation with data entered into The National Neonatal Research Database
What does the study involve?
Analysis of data already collected in the National Neonatal Research Database exploring impact of antibiotics on NEC
What are the possible benefits and risks of participating?
There are no benefits or risks to individuals as this is a database analysis of existing data
Where is the study run from?
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2020 to December 2023
Who is funding the study?
1. Investigator initiated and funded
2. Novo Nordisk Fonden
Who is the main contact?
Dr Janet Berrington
janet.berrington1@nhs.net
Contact information
Principal Investigator
Neonatal Unit
Ward 35
Royal Victoria Infirmary
Richardson Road
Newcastle
NE1 4LP
United Kingdom
0000-0002-6185-2843 | |
Phone | +44 (0)1912829323 |
janet.berrington1@nhs.net |
Study information
Study design | Analysis of data already collected in the National Neonatal Research Database exploring impact of antibiotics on NEC |
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Primary study design | Observational |
Secondary study design | Case-control study |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | No participant information sheet available |
Scientific title | Early antibiotic use and incidence of necrotising enterocolitis in very preterm infants: A UK based observational study using routinely recorded data |
Study objectives | Early antibiotic timing and duration impacts incidence of necrotising enterocolitis (NEC) in preterm infants |
Ethics approval(s) | Approval pending, Ref: 22/NE/0113 |
Health condition(s) or problem(s) studied | Preterm infant |
Intervention | We will access and extract details about infants with gestation <32 completed weeks, and the primary outcome measure of developing necrotising enterocolitis. We will also extract data on antibiotic exposure in the first 2 days to compare NEC incidence in those on antibiotics in the first 2 days with those without. We will collect additional data to allow for the effects of confounding factors as determined by the directed acyclic graph of other essential factors to consider in this analysis, including the availability of these items within the National Neonatal Research Database (NNRD), which holds this data routinely. There is no patient intervention, all data already exists. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | Incidence of severe necrotising enterocolitis resulting in death or surgery developed before discharge from neonatal care as measured by the ‘Battersby’ definition and collected from the National Neonatal Research Database (NNRD) |
Secondary outcome measures | All are measured before discharge from the neonatal unit and collected from the NNRD between 01/07/2022 and 31/12/2022: 1. Late onset sepsis (bloodstream or CSF confirmed pure growth in culture (NNAP definition) after the first 3 days and/or treatment with 5 days of antibiotics and a concurrent diagnosis of infection after the first 3 days) 2. Total antibiotic use (number of days with any treatment of antibiotics during admission) 3. Length of stay (postnatal age at discharge or death) 4. Time to reach full feeding (first day of 3 consecutive days where parenteral nutrition or intravenous fluid are not recorded) 5. Growth (change in standard deviation score (SDS) between birth and 36 weeks and discharge) 6. Total pre-discharge mortality 7. Further, we will analyse effects on some relevant adverse outcomes: 7.1 Total pre-discharge mortality 7.2. Death prior to day 7, day 14, day 28 7.3 Bronchopulmonary dysplasia (BPD; respiratory support given at 36 weeks) 7.4. Retinopathy of prematurity (ROP; in receipt of treatment, according to NNRD standard operating procedure) 7.5. Brain injury (intraventricular hemorrhage grade 3 or above or periventricular leukomalacia diagnoses recorded) 7.6. Need for surgical procedures |
Overall study start date | 01/01/2020 |
Completion date | 31/12/2023 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 45,000 |
Key inclusion criteria | 1. Preterm infant born at <32 weeks gestation 2. Data entered into the The National Neonatal Research Database |
Key exclusion criteria | Death before 3 days |
Date of first enrolment | 01/07/2022 |
Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centre
(Ward 35)
Richardson Road
Newcastle
NE1 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
Richardson Road
Newcastle
NE1 4LP
England
United Kingdom
Phone | +44 (0)191 2825789 |
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Aaron.jackson@nhs.net | |
Website | http://www.newcastle-hospitals.org.uk/ |
https://ror.org/05p40t847 |
Funders
Funder type
Other
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Novo Nordisk Foundation, Novo Nordic Foundation, NNF
- Location
- Denmark
Results and Publications
Intention to publish date | 31/12/2024 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Janet Berrington janet.berrington1@nhs.net |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | 15/11/2022 | 23/11/2022 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 31/12/2023.
2. The overall end date was changed from 31/12/2022 to 31/12/2023.
3. The intention to publish date was changed from 01/07/2023 to 31/12/2024.
4. The plain English summary was updated to reflect these changes.
23/11/2022: Protocol added.
13/06/2022: Trials existence confirmed NHS REC.