DRKS00013197Recruiting未知
PRIMAL Clinical Study: Efficacy of probiotics to prevent gut dysbiosis in very preterm infants (VPIs) and moderate preterm infants of 28+0 – 32+6 weeks of gestation: A randomized, placebo-controlled double-blind study - primalstudy
niversitätsklinikum Schleswig-Holstein0 sites654 target enrollmentStarted: March 23, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 654
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 28 Pregnancy to 32 Pregnancy (—)
- Sex
- All
Inclusion Criteria
- •Key inclusion criteria for participating in the PRIMAL trial in the first 48 hours of life are:
- •1. Patients (or as appropriate whose legal guardian) have been informed about the study procedures and interventions and have given written informed consent; 2. Female or male preterm infants born between 28 0/7 to 32 6/7 gestational weeks of any ethnic background, who are admitted to of the listed study sites within the first 48h of life.
Exclusion Criteria
- •1. Infants with lethal malformations or severe gastrointestinal malformations, which preclude appropriate enteral feeding or require surgery within the primary observational time of 28 days. 2. Infants who primarily present with NEC (Bell´s stage = 1B) or with any medical condition that is likely to be lethal in the first 48 h of life.
Investigators
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