Bacterial lysate treatment to prevent respiratory infections in preterm infants
Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
PHASE3 · Franciscus Gasthuis · NCT05063149
This study is testing if a bacterial treatment can help prevent respiratory infections and wheezing in preterm infants during their first year of life.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 6 Weeks to 10 Weeks |
| Sex | All |
| Sponsor | Franciscus Gasthuis (other) |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05063149 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to reduce respiratory tract infections and wheezing in moderate-late preterm infants through the administration of bacterial lysates. A total of 500 otherwise healthy infants will be randomly assigned to receive either the bacterial lysate (OM-85/Broncho-Vaxom) or a placebo for ten days each month, starting from 6-10 weeks after birth until they reach 12 months. The study will also collect clinical data and biological samples to investigate immune maturation and microbiome development, with follow-up assessments at 6, 12, and potentially 24 months. The primary outcomes will focus on doctor-diagnosed lower respiratory tract infections and wheezing episodes during the first year of life.
Who should consider this trial
Good fit: Ideal candidates for this study are moderate-late preterm infants born between 30 and 35 weeks of gestation who are otherwise healthy.
Not a fit: Patients with severe underlying respiratory diseases, significant cardiac issues, or those who have experienced lower respiratory tract infections prior to randomization may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of respiratory infections and wheezing in preterm infants, improving their overall health outcomes.
How similar studies have performed: While the approach of using bacterial lysates is promising, it is relatively novel in this specific population, and previous studies have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rotterdam, South Holland
- Franciscus Gasthuis & Vlietland — Rotterdam, South Holland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Inger van Duuren
- Email: proteastudie@franciscus.nl
- Phone: 0031 10 893 61 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Wheezing, LRTI, Premature