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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.05.2025

Trial locations

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.

Investigated diseases:

Bronchopulmonary dysplasia

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.

Trial ID:

2024-519980-16-00

Protocol code:

BuS2020

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?