Actively Recruiting

Phase 3
Age: 6Weeks - 10Weeks
All Genders
NCT05063149

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

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

500

Participants Needed

1

Research Sites

254 weeks

Total Duration

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Sponsors

F

Franciscus Gasthuis

Lead Sponsor

L

Leiden University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.

CONDITIONS

Official 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+0 and 35+6 weeks
  • Postnatal age at least 6 weeks at randomization and postmenstrual age at least 37 weeks
  • Written informed consent by both parents or formal caregivers
Not Eligible

You will not qualify if you...

  • Underlying 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 and/or weight below 2.5 kg at age of randomization
  • Maternal use of TNF-alpha inhibitors or other immunosuppressants during pregnancy or breastfeeding
  • Parents unable to speak and read Dutch or English
  • Known allergic hypersensitivity to the active ingredients or excipients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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