Intestinal PerforationNCT06515405
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants
An observational study of Intestinal Perforation, run by Imperial College London at 1 site in United Kingdom.
Trial summary
A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32 weeks' gestation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intestinal Perforation
- What is being tested?
- Hydrocortisone
- How many people
- 16,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2024to 30 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants born before 28 weeks' gestation and admitted to English and Welsh neonatal units.
Who may be able to join
- Infants who:
- were admitted to a neonatal unit between the 1st January 2016 and 31st March 2023 and
- received any of their care in a NHS neonatal unit in England and Wales (part of UK Neonatal Collaborative and therefore contributing data to the NNRD) and
- were born before 28 weeks' gestation.
Who cannot join
- They have missing data for principal background variables (gestational age at birth, birth weight, year of birth and date of death for those that died).
- Their recorded birthweight absolute value z score exceeds 4 or is missing.
- They died on postnatal day 1 or 2 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants: A Protocol for a Retrospective Cohort Study Using Routinely Collected Data
A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32 weeks' gestation. However, the PREMILOC trial was underpowered to investigate rarer side effects, such as gastrointestinal perforation. This study aims to establish whether the odds of gastrointestinal perforation increase when extremely preterm infants are given prophylactic hydrocortisone in the first ten days of life.
This retrospective cohort study will use routinely collected data from the U.K. National Neonatal Research Database. The investigators will examine the records of all infants born before 28 weeks' gestation and cared for in English and Welsh neonatal units between 2016 and 2023. Infants will be considered exposed if they received hydrocortisone for at least eight consecutive days, beginning on postnatal day 1 or 2. The primary outcome will be gastrointestinal perforation, as recorded in the infant's neonatal unit record. This outcome will be validated with the original care teams for a sample of babies. Data will be analysed using a propensity score matched approach to reduce the impact of confounding.
- Conditions
- Intestinal Perforation
- Being tested
- Hydrocortisone
- Keywords
- Preterm Infant, Hydrocortisone
- Medical subject headings
- Intestinal Perforation, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Cohort members will be considered to be exposed to early hydrocortisone if either:
- They receive early hydrocortisone started on postnatal day 1 or 2 and given for more than seven consecutive days OR
- They receive early hydrocortisone started on postnatal day 1 or 2 and are being cared for in a PROHYDRO unit but die on or before postnatal day 8.
PROHYDRO units are defined as units who, at the time the baby was born, had implemented a protocol for use of prophylactic hydrocortisone as part of routine care for babies born less than 28 weeks' gestation. A unit may change from being a non-PROHYDRO unit to a PROHYDRO unit if a new early hydrocortisone protocol is introduced during the study period (2016-2023).
| Study group | Role | What they receive |
|---|---|---|
| Not exposed to early hydrocortisone | Not described Receives: Drug: Hydrocortisone | |
| Exposed to early hydrocortisone | Not described Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal (GI) perforation
A baby will be considered to have had a gastrointestinal perforation if their National Neonatal Research Database record includes a record of a GI perforation in the diagnoses field.
Measured: From date of birth until day 14 of life
Secondary outcomes (6)
Survival without gastrointestinal perforation
Baby survived to discharge from neonatal unit without a gastrointestinal perforation
Measured: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Mortality before discharge home
Baby died before discharge from neonatal unit
Measured: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Total length of stay
Length of stay in neonatal care
Measured: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Proportion of days on unit being mechanically ventilated
Measured: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Bronchopulmonary dysplasia
any respiratory or ventilatory support or supplemental oxygen at 36 weeks' postmenstrual age (PMA)
Measured: From date of birth until 36 weeks' postmenstrual age (PMA)
Bronchopulmonary dysplasia
Using an adapted Jensen criteria based on the highest level of respiratory support at 36 weeks PMA
Measured: From date of birth until 36 weeks' postmenstrual age (PMA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start30 Jul 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal PerforationStudies 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
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515405
- Sponsor's protocol ID
- 293603
- Status last verified
- Oct 2024
- First submitted
- 17 Jul 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Study protocol available now. Analysis code will be available after publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants: A Protocol for a Retrospective Cohort Study Using Routinely Collected Data
- ClinicalTrials.gov ID
- NCT06515405
- Acronym / sponsor ID
- 293603
- Conditions
- Intestinal Perforation
- Keywords
- Preterm Infant, Hydrocortisone
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32 weeks' gestation. However, the PREMILOC trial was underpowered to investigate rarer side effects, such as gastrointestinal perforation. This study aims to establish whether the odds of gastrointestinal perforation increase when extremely preterm infants are given prophylactic hydrocortisone in the first ten days of life.
This retrospective cohort study will use routinely collected data from the U.K. National Neonatal Research Database. The investigators will examine the records of all infants born before 28 weeks' gestation and cared for in English and Welsh neonatal units between 2016 and 2023. Infants will be considered exposed if they received hydrocortisone for at least eight consecutive days, beginning on postnatal day 1 or 2. The primary outcome will be gastrointestinal perforation, as recorded in the infant's neonatal unit record. This outcome will be validated with the original care teams for a sample of babies. Data will be analysed using a propensity score matched approach to reduce the impact of confounding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not exposed to early hydrocortisone | – | Drug: Hydrocortisone |
| Exposed to early hydrocortisone | – | Drug: Hydrocortisone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born before 28 weeks' gestation and admitted to English and Welsh neonatal units.
Key inclusion criteria (4 listed)
- were admitted to a neonatal unit between the 1st January 2016 and 31st March 2023 and
- received any of their care in a NHS neonatal unit in England and Wales (part of UK Neonatal Collaborative and therefore contributing data to the NNRD) and
- were born before 28 weeks' gestation.
Key exclusion criteria (3 listed)
- They have missing data for principal background variables (gestational age at birth, birth weight, year of birth and date of death for those that died).
- Their recorded birthweight absolute value z score exceeds 4 or is missing.
- They died on postnatal day 1 or 2 .
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 |
|---|---|---|
| HydrocortisoneCohort members will be considered to be exposed to early hydrocortisone if either: 1. They receive early hydrocortisone started on postnatal day 1 or 2 and given for more than seven consecutive days OR 2. They receive early hydrocortisone started on postnatal day 1 or 2 and are being cared for in a PROHYDRO unit but die on or before postnatal day 8. PROHYDRO units are defined as units who, at the time the baby was born, had implemented a protocol for use of prophylactic hydrocortisone as part of routine care for babies born less than 28 weeks' gestation. A unit may change from being a non-PROHYDRO unit to a PROHYDRO unit if a new early hydrocortisone protocol is introduced during the study period (2016-2023). | Drug | Exposed to early hydrocortisone, Not exposed to early hydrocortisone |
Primary outcome
Gastrointestinal (GI) perforation
Time frame: From date of birth until day 14 of life
A baby will be considered to have had a gastrointestinal perforation if their National Neonatal Research Database record includes a record of a GI perforation in the diagnoses field.
6 secondary outcomes
Survival without gastrointestinal perforation
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Mortality before discharge home
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Total length of stay
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Proportion of days on unit being mechanically ventilated
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Bronchopulmonary dysplasia
Time frame: From date of birth until 36 weeks' postmenstrual age (PMA)
Bronchopulmonary dysplasia
Time frame: From date of birth until 36 weeks' postmenstrual age (PMA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Undecided. Study protocol available now. Analysis code will be available after publication of results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intestinal Perforation, 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gastrointestinal (GI) perforation (time frame: From date of birth until day 14 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.