Actively Recruiting

Phase 3
Age: 6Weeks - 10Weeks
All Genders
ID05063149

Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.

Led by Franciscus Gasthuis · Updated on 2024-08-22

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

F

Franciscus Gasthuis

Lead Sponsor

L

Leiden University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of bacterial lysates to reduce respiratory tract infections and wheezing in moderate to late preterm infants during their first years of life. This randomized, placebo-controlled Phase 3 trial involves 500 otherwise healthy preterm infants born between 30 and 35 weeks gestational age. The study also aims to explore biological markers related to respiratory symptoms, immune protection, and treatment effects. Participants will receive either a bacterial lysate called Broncho-Vaxom (3.5 mg) or a placebo powder for ten days each month. This treatment starts from 6 to 10 weeks after birth and continues until the infants reach 12 months of age. At 12 months, parents are invited to join an extension called Protea-2, where children initially treated with Broncho-Vaxom are randomized again to receive either Broncho-Vaxom or placebo until 24 months old. Throughout the study, clinical data will be gathered continuously using e-Health tools and three scheduled visits, which may be digital. Optional biological samples and lung function tests will be collected at baseline, 6 months, 12 months, and at 24 months if participating in Protea-2. Researchers will measure the number of doctor-diagnosed lower respiratory tract infections and wheezing episodes, track immune system development and microbiome changes, and assess medication use, quality of life, and safety events.

CONDITIONS

Brief Title

Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

Who Can Participate

Age: 6Weeks - 10Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age at delivery between 30 weeks 0 days and 35 weeks 6 days
  • Postnatal age at least 6 weeks and postmenstrual age at least 37 weeks at randomization
  • Written informed consent given by both parents or formal caregivers
Not Eligible

You will not qualify if you...

  • Severe respiratory diseases such as broncho-pulmonary dysplasia
  • Hemodynamically significant cardiac disease
  • Immunodeficiency
  • Severe failure to thrive
  • Birth asphyxia with predicted poor neurological outcome
  • Syndrome or serious congenital disorder
  • Lower respiratory tract infection before randomization
  • Dysmaturity or weight less than 2.5 kg at randomization
  • Maternal use of TNF-alpha inhibitors or other immunosuppressants during pregnancy or breastfeeding
  • Parents unable to speak or read Dutch or English
  • Known allergic hypersensitivity to the study drug or its ingredients

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From 6 to 10 weeks after birth until 12 months of age

Participants receive bacterial lysate or placebo powder for 10 days each month, starting from 6 to 10 weeks after birth until 12 months of age.

3 study visits with optional biological sampling and lung function assessments at baseline, 6 months, and 12 months

Treatment

Duration - From 12 months until 24 months of age

Participants who join Protea-2 at 12 months and were in the treatment arm are randomized again to receive bacterial lysate or placebo until 24 months of age.

Additional study visit at 24 months for biological sampling and lung function assessment

Monitoring

Duration - From enrollment until 24 months of age

Clinical data are continuously collected via e-Health throughout the study to monitor respiratory tract infections and wheezing episodes.

Continuous remote data collection with 3 in-person visits during the first year and 1 visit at 24 months if participating in Protea-2

Trial Site Locations

Total: 1 location

1

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, Netherlands, 3045PM

Actively Recruiting

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Research Team

I

Inger van Duuren

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Moderately preterm children have more respiratory problems during their first 5 years of life than children born full term.

Elianne J L E Vrijlandt, Jorien M Kerstjens, Eric J Duiverman...

https://pubmed.ncbi.nlm.nih.gov/23525931

Risk factors for bronchiolitis, recurrent wheezing, and related hospitalization in preterm infants during the first year of life.

Eduardo G Pérez-Yarza, Antonio Moreno-Galdó, Octavio Ramilo...

https://pubmed.ncbi.nlm.nih.gov/26031206

Temporal bacterial and metabolic development of the preterm gut reveals specific signatures in health and disease.

Christopher J Stewart, Nicholas D Embleton, Emma C L Marrs...

https://pubmed.ncbi.nlm.nih.gov/28034304