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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Wheezing, LRTI, Premature

In brief

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.

Key facts

Study ID

NCT05063149

Run by

Franciscus Gasthuis

People needed

500

Starts

2022-01-18

Expected to finish

2026-12-01

Last updated by the study team

2024-08-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Lower RTI before randomization
• Dysmaturity and/or weight < 2.5 kg at age of randomization.
• 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.

Where it is running

• Franciscus Gasthuis & Vlietland — Rotterdam, South Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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