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| Name | Class |
|---|---|
| University of Nottingham | OTHER |
| Newcastle University | OTHER |
| Queen Mary University of London | OTHER |
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Necrotising enterocolitis (NEC) is one of the leading causes of mortality and morbidity in very preterm infants. This study aims to determine whether NEC rates are different between infants who receive probiotics versus infants who do not receive probiotics. The study has a retrospective cohort design and will utilise routinely collected data from the UK National Neonatal Research Database (NNRD). The cohort will comprise all infants born before 32 weeks gestation and cared for in neonatal units in England and Wales between 2016 and 2022. A propensity score matched approach will be used to conduct two comparisons: i) the risk of necrotising enterocolitis (NEC) between who do and those who do not receive probiotics in the first 14 days of life ii) the risk of NEC between babies who receive the two most common probiotic products used in UK units, (Labinic and Proprems).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed to probiotics | Receipt of any probiotic in the first 14 days of life. Probiotics to include: Labinic, Proprems probiotic, Acidophillus, Bifidobacterium, Bio-kult, Infloran, LB2. To address potential recording error, infants whose NNRD records show minimal (one day) of probiotic exposure will only be classed as exposed if they are cared for in a probiotic unit. Probiotic units are defined as:
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| |
| No probiotic exposure | Did not receive any probiotic in the first 14 days of life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Any exposure to probiotics in first 14 days of life |
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| Measure | Description | Time Frame |
|---|---|---|
| Severe necrotising enterocolitis (NEC) | NEC confirmed at surgery or postmortem or listed as a cause of death | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Necrotising enterocolitis (NNAP definition) | NEC diagnosed at postmortem or NEC diagnosed during surgery or NEC diagnosed using clinical and radiographic features (where the infant has at least one clinical feature (bilious gastric aspirate or emesis, abdominal distension, occult, gross blood in stool) and at least one radiographic feature (pneumatosis, hepato-biliary gas, pneumoperitoneum)). | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Infants born very preterm i.e. before 32 weeks gestation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College | London | SW10 9NH | United Kingdom |
Study protocol available now. Analysis code will be available after publication of results.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2025 | Apr 23, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Pragmatically defined NEC | Infants who had a recorded diagnosis of necrotising enterocolitis and received at least 5 consecutive days of antibiotics whilst also nil by mouth | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Late onset sepsis | HQIP NNAP case definition | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Pragmatically defined late onset sepsis | Growth of any organisms that appear in the NNAP lists of "Clearly pathogenic organisms" and "Other organisms" | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Survival to discharge home | On date of discharge from final neonatal unit, assessed up to 24 months |
| Survival without severe NEC or late onset sepsis (LOS) | LOS is defined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition i.e. blood stream or cerebrospinal fluid confirmed pure growth in culture after first three days of life | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Survival without any NEC | NEC is defined as per the NNAP definition | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Brain injury | Either left or right grade 3 or higher intra-ventricular haemorrhage or cystic periventricular leukomalacia | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Treated retinopathy of prematurity | Defined as cryotherapy, laser therapy or injection of anti-vascular endothelial growth factor therapy for ROP in either or both eyes | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Stage of retinopathy of prematurity | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Bronchopulmonary dysplasia | Defined as any respiratory or ventilatory support or supplemental oxygen at 36 weeks postmenstrual age | 36 weeks postmenstrual age |
| Severe bronchopulmonary dysplasia | Defined as ventilation via endotracheal tube or trachestomy, and excluding non-invasive support or CPAP, at 36 weeks postmenstrual age | 36 weeks postmenstrual age |
| Length of stay | Number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants | From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months |
| Time to full feeds | Defined as the number of days until an infant is recorded as not requiring any parenteral nutrition or fluid (i.e. no parenteral nutrition or intravenous dextrose) | Before discharge from final neonatal unit |
| Growth | Weight for post-menstrual age standard deviation score | 36 weeks corrected gestational age |
| D007410 |
| Intestinal Diseases |
| D019602 |
| Food and Beverages |