Early antibiotic use and intestinal disease (necrotising enterocolitis) in premature babies

Early antibiotic use and incidence of necrotising enterocolitis in very preterm infants: A UK based observational study using routinely recorded data

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN55101779

Enrollment

45000

Registered

2022-07-13

Start date

2022-07-01

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm infant Neonatal Diseases

Interventions

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 ex

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Preterm infant born at <32 weeks gestation 2. Data entered into the The National Neonatal Research Database

Exclusion criteria

Exclusion criteria: Death before 3 days

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026