Not recruiting

Study on Budesonide and Poractant Alfa for Preventing Lung Disease in Very Preterm Infants

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Bronchopulmonary Dysplasia (BPD), which affects the lungs of very preterm infants, specifically those born at or before 32 weeks of gestation. The study aims to explore the effectiveness and safety of a treatment that combines two medications: Budesonide and a surfactant called Poractant Alfa. Budesonide is a type of medication known as a corticosteroid, which helps reduce inflammation, while Poractant Alfa is a surfactant that helps the lungs function better by reducing surface tension in the airways.

The purpose of the study is to see if the combination of Budesonide and Poractant Alfa can help prevent BPD in these very preterm infants. During the study, some infants will receive the combination treatment, while others will receive only the surfactant. The study will monitor the infants' lung health and inflammation levels over time, using methods like lung ultrasound and checking for specific markers in their respiratory system. The safety of the treatment will also be closely observed, looking for any potential side effects or complications.

The study will follow the infants for a period of time to assess their lung development and overall health. This includes checking their need for oxygen and respiratory support, as well as evaluating their neurodevelopment at two years of age. The goal is to gather information that could lead to better treatments for preventing BPD in preterm infants, ultimately improving their long-term health outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves preterm newborns who are 32 weeks of gestational age or younger. Participation requires the signing of an informed consent by the parents or legal representative.
Step 2
Initial treatment
The treatment involves the intratracheal administration of a combination of budesonide and poractant alfa. Budesonide is a medication used to reduce inflammation, and poractant alfa is a surfactant that helps the lungs function better.
The administration is performed through a procedure called endotracheopulmonary instillation, which delivers the medication directly into the lungs.
Step 3
Monitoring and evaluation
The primary goal is to assess the effectiveness of the treatment in preventing bronchopulmonary dysplasia, a lung condition common in preterm infants.
Lung ultrasound and biological markers, such as IL-6 concentration in nasopharyngeal aspirate, are evaluated on day 7 of life to measure efficacy.
Safety is monitored by checking for any signs of infection, gastrointestinal issues, or other adverse effects.
Step 4
Ongoing assessments
Further lung ultrasounds are conducted on days 3, 14, 21, and 28 of life, and at 36 weeks postmenstrual age or before discharge.
IL-6 concentration is also measured on day 28 of life.
The number of days requiring oxygen and respiratory support is recorded at 28 days of life and 36 weeks postmenstrual age or before discharge.
Step 5
Long-term follow-up
At 2 years of age, a neurodevelopmental assessment is performed using the Bayley III test, which evaluates cognitive and motor skills, language, and processing speed.
Respiratory outcomes are also assessed, including the need for home oxygen therapy, any ongoing treatments, and the number of hospital admissions due to respiratory issues.

Who can join the trial?

5 criteria

The baby must be born **preterm**, which means before completing 37 weeks of pregnancy, specifically **32 weeks or less**.
The baby can be of any **birth weight**.
The baby must be admitted to the **Neonatal Unit**, which is a special area in the hospital for newborns who need extra care.
The baby's **parents or legal representative** must sign a document called **informed consent**, which means they agree to let the baby participate in the study after understanding what it involves.
Both **male and female** babies can participate.

Who cannot join the trial?

3 criteria

Newborns older than 32 weeks of pregnancy cannot participate.
Newborns who do not have bronchopulmonary dysplasia cannot participate. This is a lung condition that affects babies, especially those born early.
Newborns who are not preterm, meaning they were not born before the full term of pregnancy, cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Budesonide
is a medication used in this trial to help prevent bronchopulmonary dysplasia in very preterm infants. It is administered directly into the trachea, combined with a surfactant, to reduce inflammation in the lungs and improve breathing.
Porcine Pulmonary Surfactant
is a substance used in this trial to help the lungs of very preterm infants function better. It is combined with budesonide and administered directly into the trachea. The surfactant helps to keep the air sacs in the lungs open, making it easier for the infants to breathe.

What is already known about the treatment

Budesonide – Budesonide is administered intratracheally, often combined with a surfactant, to very preterm infants to prevent bronchopulmonary dysplasia. It is currently being studied in clinical trials for its efficacy and safety in this context. The main therapeutic indication is to reduce the incidence of bronchopulmonary dysplasia in preterm newborns born at or before 32 weeks of gestational age. Budesonide works by reducing inflammation in the lungs at the molecular level, acting as a corticosteroid. It is classified pharmacologically as a glucocorticoid.

Investigated diseases

Bronchopulmonary Dysplasia
A chronic lung condition that affects newborns, primarily those born prematurely. It occurs when the lungs are not fully developed and have been damaged, often due to mechanical ventilation and oxygen therapy. The disease is characterized by inflammation and scarring in the lungs, leading to breathing difficulties. Over time, affected infants may experience reduced lung function and require prolonged respiratory support. The condition can improve as the child grows, but some may have long-term respiratory issues.
Preterm Newborns ≤32 Weeks of Gestational Age
Refers to infants born before completing 32 weeks of pregnancy. These newborns are at a higher risk for various health complications due to their underdeveloped organs. They often require specialized medical care, including support for breathing, feeding, and maintaining body temperature. The lungs, in particular, may be immature, leading to conditions like respiratory distress syndrome. As they grow, these infants may face challenges in development and health, necessitating ongoing monitoring and care.