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โ† Trials
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Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

RecruitingPhase 3Ages 6 Weeks - 10 WeeksAllFranciscus Gasthuis
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Gestational age at delivery between 30+0 and 35+6 weeks * Postnatal age at least 6 weeks at randomization \& postmenstrual age at least 37 weeks * Written informed consent by both parents or formal caregivers Exclusion Criteria: * Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder. * Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding * Parents unable to speak and read Dutch/English language * Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
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What it tests

  • Broncho-Vaxom
  • Placebo
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Where

1 site
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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