Active not recruitingPHASE3INTERVENTIONAL

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

This important study, called 'The Connection Study,' is looking for premature babies to help test a new medicine named IBP-9414. We're trying to prevent a serious bowel condition called necrotising enterocolitis (NEC), which can affect babies born very early and very small. Doctors will compare IBP-9414 with a 'placebo' – a dummy medicine that looks the same but has no active ingredient. This helps us see if IBP-9414 really makes a difference. We'll be checking if the medicine is safe and if it helps stop NEC in these tiny babies. The study is for babies born between 23 and 32 weeks, weighing between 500g and 1500g, and who are less than 48 hours old.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Infant Bacterial Therapeutics

Enrolment target

2,158

Start

04 Jul 2019

Estimated completion

01 Jul 2024

Necrotizing Enterocolitis

What is this study about?

This study is about a very serious gut problem called necrotising enterocolitis, or NEC, which can affect babies born very early (prematurely). When a baby is born too soon, their organs, including their gut, are not fully developed. This can sometimes lead to inflammation and damage in the intestines, which is what NEC is. It can be very dangerous for these tiny babies.

Researchers are testing a new medicine called IBP-9414 because they hope it can help prevent NEC from happening. They believe this medicine might strengthen the baby's gut or help good bacteria grow, making it less likely for NEC to develop. The study will look carefully at whether IBP-9414 is effective and safe for premature babies.

To find out if IBP-9414 works, some babies will receive the new medicine, while others will get a 'placebo.' A placebo is a dummy medicine that looks exactly like the real one but doesn't contain any active ingredients. This is a standard way to test new medicines and helps doctors accurately see if the real medicine is having an effect, or if improvements happen anyway. This study is important because finding a way to prevent NEC could save lives and improve the health of many premature babies.

Key takeaways

This study tests a new medicine (IBP-9414) for premature babies.
It aims to prevent a serious gut condition called necrotising enterocolitis (NEC).
Babies will receive either the new medicine or a dummy medicine (placebo).
It's for very early and very small babies, under 48 hours old.
Safety and effectiveness will be closely monitored throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for very tiny, premature babies. To be considered, a baby must have been born between 23 weeks and 32 weeks of pregnancy and weigh between 500 grams (about 1lb 2oz) and 1500 grams (about 3lb 5oz). They also need to be less than 48 hours old when they join the study.

There are also some reasons why a baby might not be able to join. For example, if they are already taking part in another study, or if their doctors believe they have a very serious infection already, or a known problem with their chromosomes. Babies with certain gut diseases or whose mothers have HIV also can't join. Lastly, if a baby has already received other treatments that contain live bacteria, they wouldn't be able to participate.

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 23 and 32 weeks of pregnancy?
Did your baby weigh between 500g and 1500g at birth?
Is your baby less than 48 hours old?
Has your baby NOT participated in any other medical studies recently?
Does your baby have any known serious infections or gut problems?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, they would receive either the test medicine, IBP-9414, or a placebo (dummy medicine). This would be given for a set period. Doctors and nurses would closely monitor your baby's health and well-being throughout the study, just as they would any other premature baby. They would perform regular checks and assessments to see how your baby is doing and if the medicine is having any effects. There will be follow-up appointments to check on your baby's health over time. The exact number of visits and the total length of your baby's involvement will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new medicine, IBP-9414, proves effective in preventing NEC. This could improve your baby's chances of avoiding a very serious illness. However, as with any new medicine, there might be unknown side effects or risks, even though safety is carefully monitored. Some babies will receive a placebo, meaning they won't get the active medicine. You are always free to change your mind and withdraw your baby from the study at any time, for any reason, without affecting their medical care.

Locations (89)

Banner University Medical Center / University of Arizona
Verified postcode
Tucson, United States
Arkansas Children'S Hospital
Verified postcode
Little Rock, United States
University of Arkansas For Medical Services
Verified postcode
Little Rock, United States
Loma Linda University Children Hospital
Verified postcode
Loma Linda, United States
Good Samaritan Hospital
Verified postcode
Los Angeles, United States
LAC & USC Medical Center
Verified postcode
Los Angeles, United States
University of Califorina, Los Angeles (UCLA)
Verified postcode
Los Angeles, United States
Valley Childrens Hospital
Verified postcode
Madera, United States
Sharp Memorial Hospital
Verified postcode
San Diego, United States
St. Francis Medical Center
Verified postcode
Colorado Springs, United States
Connecticut Children'S Medical Center - Uconn - School of Medicine
Verified postcode
Hartford, United States
University of Florida Health
Verified postcode
Gainesville, United States

Common questions

What is necrotising enterocolitis (NEC)?

NEC is a serious gut problem that can affect premature babies, where parts of their bowel become inflamed and damaged.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real treatment but doesn't contain any active ingredients. It helps researchers see if the actual medicine truly works.

Will my baby definitely get the new medicine?

No, your baby will be given either the new medicine (IBP-9414) or a placebo. Which one they get is decided randomly, like flipping a coin.

Is my baby's care affected if we don't join?

No, your baby's usual medical care will not be affected at all if you decide not to take part in the study.

How long will my baby be part of the study?

The study team will explain the full details, but generally, babies receive the medicine for a period, and then their health is followed up for some time after that.