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

Launched by FRANCISCUS GASTHUIS · Sep 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help protect premature infants from lung infections and wheezing by using a treatment called bacterial lysates. The goal is to see if giving these infants bacterial lysates can reduce the number of respiratory infections and wheezing episodes they experience in their early years. Researchers will also study how different biological markers relate to the infants' respiratory symptoms and their immune protection.

To be eligible for this trial, infants must be born between 30 and 35 weeks of pregnancy and be at least 6 weeks old when they start participating. Parents or caregivers need to provide written consent for their child to be part of the study. It’s important to note that infants with certain severe health conditions or previous respiratory infections may not be eligible. If a baby joins the trial, their progress will be closely monitored, and they will receive the bacterial lysate treatment as part of the study. This trial is currently recruiting participants, and all eligible infants, regardless of gender, can take part.

Gender

ALL

Eligibility criteria

• 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.
• • 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.