What side effects are associated with this type of intervention?

Common treatments for premature birth include the use of corticosteroids like budesonide and surfactants. Budesonide, a glucocorticoid, is used to reduce inflammation but can cause side effects such as adrenal suppression, growth retardation, and increased risk of infections. Surfactants, which help reduce surface tension in the lungs, are generally well-tolerated but can occasionally lead to complications like pulmonary hemorrhage, airway obstruction, and infection. Combining these treatments aims to improve lung function and reduce the incidence of bronchopulmonary dysplasia, but careful monitoring for these side effects is essential.

What prior FDA approvals exist?

The FDA has approved several treatments for premature birth that focus on improving lung function and reducing inflammation. One notable example is the use of surfactant therapy, which has been a standard treatment to reduce surface tension in the lungs of premature infants, thereby preventing respiratory distress syndrome (RDS). Additionally, corticosteroids like betamethasone and dexamethasone are commonly administered antenatally to accelerate lung maturation and reduce the risk of RDS and other complications. While budesonide combined with surfactant is currently being studied, these existing treatments share similar goals of enhancing lung function and reducing inflammation in premature infants.

What other types of research exist?

Currently, there are no specific novel alternatives to Budesonide with Surfactant mentioned in the provided context for premature birth patients. However, ongoing research in the field of respiratory distress syndrome and related conditions may yield new treatments. It is essential to consult with a neonatologist or a specialist in neonatal care for the most up-to-date and relevant treatment options available in 2024.

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Corticosteroid

Budesonide + Surfactant for Premature Birth Complications (BiB Trial)

Phase 3

Waitlist Available

Led By Namasivayam Ambalavanan, MD

Research Sponsored by NICHD Neonatal Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Liveborn infants 22 0/7 - 28 6/7 weeks gestation or 401 - 1000 grams (inclusive) birth weight

Be younger than 18 years old

Must not have

Infants with a permanent neuromuscular condition that affects respiration

Infant received systemic steroids prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22-26 months corrected age

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a mix of a steroid and a lung-helping substance on very premature babies to reduce severe lung problems or death. The treatment works by reducing lung inflammation and helping the lungs stay open. Steroids like dexamethasone have been used to treat and prevent chronic lung disease in infants, showing beneficial effects.

Who is the study for?

The BiB Trial is for liveborn infants born between 22 and 28 weeks of gestation or weighing between 401 - 1000 grams. They must be less than 48 hours old and require surfactant treatment. Infants with certain conditions, previous steroid use, enrollment in another trial, or major malformations are not eligible.

What is being tested?

This study tests if giving budesonide combined with surfactant directly into the windpipe reduces death or bronchopulmonary dysplasia (a lung condition) in extremely premature babies by the time they reach a corrected age of about nine months.

What are the potential side effects?

Potential side effects may include immune system suppression, growth delays, adrenal gland problems, thrush in the mouth and throat area from budesonide; surfactant can cause blockage of airways, changes in blood pressure, and infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born between 22 and 28 weeks of pregnancy or weighed between 401 and 1000 grams at birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has a long-term muscle condition affecting breathing.

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My infant was given steroids before joining this study.

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I have not used any surfactant treatment before joining this study.

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I have serious genetic or birth defects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22-26 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~22-26 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 22-26 months corrected age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Physiologic BPD or death

Secondary study objectives

Grade of BPD Severity

Number of Participants with Death by 2 years

Number of Participants with Death by 36 weeks' post-menstrual age

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: budesonide with surfactantExperimental Treatment1 Intervention

Infants randomized to the intervention arm receive a dose of surfactant (poractant alfa; Curosurf) mixed with budesonide (Pulmicort nebulizing suspension) within 50 hours of birth and administered via endotracheal tube.

Group II: surfactant aloneActive Control1 Intervention

Infants randomized to the active control arm receive a dose of surfactant (poractant alfa; Curosurf).

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Budesonide is a corticosteroid that reduces inflammation in the lungs, which is crucial for premature infants who often suffer from underdeveloped lungs and inflammation-related complications. Surfactant reduces surface tension within the alveoli, preventing their collapse and aiding in proper lung function. These treatments are vital for premature birth patients as they address the primary issues of lung immaturity and inflammation, thereby improving respiratory outcomes and reducing the risk of chronic lung disease.

Inhaled budesonide in ventilator-dependent preterm infants: a randomized, double-blind pilot study.