Active not recruitingOBSERVATIONAL

Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants

This study is investigating if giving a medicine called hydrocortisone to extremely premature babies in their first ten days of life increases the risk of a rare but serious gut problem called intestinal perforation. Previous research showed hydrocortisone helps prevent a lung condition in these babies. However, that study wasn't big enough to look at rare side effects like gut problems. Researchers are looking back at anonymous health records from thousands of babies born very early (before 28 weeks) in England and Wales between 2016 and 2023. They will compare babies who received hydrocortisone with those who didn't, to see if the gut problem happened more often in one group. This will help doctors understand the full picture of hydrocortisone treatment for these vulnerable infants.

At a glance

Status

Active not recruiting

Sponsor

Imperial College London

Enrolment target

16,000

Start

30 Jul 2024

Estimated completion

30 Aug 2025

Intestinal Perforation

What is this study about?

This study is about a medicine called hydrocortisone, which is sometimes given to very premature babies (those born before 28 weeks of pregnancy, which is much earlier than the usual full term of 40 weeks). A previous large study found that giving a small dose of hydrocortisone in the first ten days of a premature baby's life could help prevent a serious lung problem called bronchopulmonary dysplasia. This is good news, as it helps these tiny babies breathe better as they grow.

However, that earlier study focused mainly on the lung benefits and wasn't large enough to spot any rare side effects. This new study wants to find out if there's a higher chance of a rare gut problem called 'intestinal perforation' when these extremely premature babies are given hydrocortisone. Intestinal perforation is when a small hole forms in the baby's bowel, which can be very serious.

To do this, researchers are looking at existing health records from babies who were cared for in hospitals in England and Wales between 2016 and 2023. They will carefully examine these records to compare babies who received hydrocortisone with those who didn't, to see if the gut problem happened more often in the hydrocortisone group. This type of study, called a 'retrospective cohort study,' uses information that has already been collected, so no new tests or treatments will be given to babies. It's a way for doctors to learn more about the safety of treatments that are already in use, helping them make the best decisions for future premature babies.

Key takeaways

Researchers are investigating a potential rare side effect of a common medicine given to very premature babies.
The medicine, hydrocortisone, helps premature babies with lung development.
The potential side effect being studied is a serious gut problem called intestinal perforation.
This study uses existing, anonymous hospital records from babies born between 2016 and 2023.
The findings will help doctors make safer treatment decisions for future premature babies.

Who may be eligible?

This study is looking at information from babies who were born extremely prematurely in England and Wales between January 2016 and March 2023. Specifically, they are including babies who were born before 28 weeks of pregnancy.

They are only focusing on babies who received hospital care in a neonatal unit (a special ward for newborns) in England or Wales, which contributed information to a national database. The researchers need certain basic information about each baby, like their age when born and their birth weight, for them to be included in the study.

Babies would not be included if some crucial information (like gestational age, birth weight, or date of death) is missing from their records. Also, if a baby's birth weight is unusually high or low for their gestational age, or if they passed away on their first or second day of life, their records would not be used in this particular study analysis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Was your baby born between January 2016 and March 2023?
Was your baby born very early, before 28 weeks of pregnancy?
Did your baby receive care in a neonatal unit in England or Wales?
Are your baby's basic details (like birth weight and birth date) clearly recorded in their hospital notes?

Answer every question to see your result.

What does participation involve?

You or your baby will not actively 'take part' in this study. This study does not involve new medicines, tests, or appointments. Instead, researchers are looking back at anonymous health information already collected as part of routine hospital care between 2016 and 2023. Your consent for this type of research is usually covered by general consent for data use in research within the NHS, but your personal information will be protected and anonymised.

Potential risks and benefits

This study uses existing, anonymised data, so there are no direct risks or benefits for individual children or families involved. The potential benefit is that the study will help doctors better understand the safety of hydrocortisone treatment for extremely premature babies. This knowledge can help guide future medical decisions and potentially make treatments safer and more effective for other vulnerable infants. While you are not directly involved, the right to object to your child's data being used in research generally exists, and you can discuss this with your healthcare provider if you have concerns.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College
Verified postcode
London, United Kingdom

Common questions

What is intestinal perforation?

Intestinal perforation is a very serious condition where a tiny hole forms in a baby's bowel or intestine.

What is hydrocortisone?

Hydrocortisone is a type of steroid medicine that is sometimes used to help premature babies develop their lungs.

Will my baby be given hydrocortisone for this study?

No, this study is looking at past medical records, so no new medicines will be given to any babies because of this research.

How will my baby's privacy be protected?

The researchers will use anonymous information, meaning your baby's name or personal details will not be connected to the data they study.

When were the babies in this study born?

The study is looking at records of babies born between January 2016 and March 2023.