NL-OMON55914
Recruiting
Phase 3
Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates. - PROTEA
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- respiratory tract infections and wheezing
- Sponsor
- Franciscus Gasthuis & Vlietland
- Enrollment
- 500
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •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;
- •immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor
- •neurological out\-come; syndrome or serious congenital disorder.
- •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.
Outcomes
Primary Outcomes
Not specified
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