Overview

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

Status:
Not yet recruiting

Trial end date:
2026-04-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Franciscus Gasthuis

Collaborators:

Leiden University Medical Center
Maastricht University Medical Center

Treatments:

Broncho-Vaxom

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.