PRIMAL - Priming Immunity at the beginning of Life
Networks
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Datasets
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Variables
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Efficacy of Bifidobacterium longum subsp. infantis, Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (La-5) probiotics early in life of preterm infants to prevent colonization with multidrug-resistant organisms or highly epidemic bacteria (MDRO+) and to shape the microbiome of preterm infants toward the eubiotic state of healthy full-term infants.
Visit PRIMAL
| Investigators | Contacts |
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Overview
- Acronym
- PRIMAL
- Start Year
- 2018
- End Year
- 2020
- Follow Up Is Ongoing
- Year of Most Recent Data Collection
- 2020
- New Data Collection planned?
- Yes
- Funding
- yes, Federal Ministry of Education and Research (BMBF), 1.656.509 Mio €
Access
Access to external researchers or third parties provided or foreseen.
- Data (questionnaire-derived, measured...)
- Biosamples
- Other access
Study Design
- Study design
- Clinical trial
- Number of Data Collection Events
- 4
- Number of very preterm (VPT) and/or very low birthweight (VLBW) births included in cohort (live & still births)
- 475
- Number of term-born control births included in cohort (live & still births)
- 0
- Supplementary information about number of participants
- Single centre study EMMA (Impact of Mother’s Own Milk on the Development of Allergy and Airway Infections) including healthy term born exclusively breastfeed infants as reference
Marker Paper
-DOI: 10.1136/bmjopen-2019-032617 (BMJ Open 2019 Nov 21;9(11):e032617) -DOI:10.1001/jamapediatrics.2024.2626 (JAMA Pediatrics (2024) 178(10) 985-995
PUBMED 39102225
- Additional Publications
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- DOI: 10.1128/msphere.00808-21 (mSphere. 2022 Feb 23;7(1):e008082; PMID: 35019670)
Timeline
PRIMAL
Inclusion of moderate preterm infants born at 28+0 to 32+6 weeks of gestational age
Selection Criteria
- Countries
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- Germany
- Geographical Area
- 18 level 1 NICUs all over Germany
- VPT/VLBW Group Inclusion Criteria
- written informed consent of parents/caregivers and admission within 48 hours of life
- Control Group Inclusion Criteria
- Inclusion criteria were identical for the control and verum groups
- VPT/VLBW Group Exclusion Criteria
- Major malformations incompatible with survival beyond 48 hours or severely affecting the gastrointestinal tract (precluding adequate enteral feeding, requiring neonatal surgery, or associated with NEC Bell stage ≥1B)
- Control Group Exclusion Criteria
- Exclusion criteria were identical for the control and verum groups
Data Collection Events
| # | Name | Description | Start | End |
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| 0 |
Perinatal
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Primary study with data collection from prenatal maternal data and data concerning the preterm infant from birth to discharge, with FU planned at 6 months, 1 year and 2 years of corrected age. | 2018-04 | 2020-06 |
| 1 |
FU 6 months
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6 month Follow-up data collection via structured telephone interviews with parents | 2018-04 | 2020-06 |
| 2 |
FU 12 months
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12 month Follow-up data collection via structured telephone interviews with parents and a physician and cognitive examinations (1-year onsite subgroup) | 2018-04 | 2020-06 |
| 3 |
FU 24 months
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24 month Follow-up data collection via structured telephone interviews with parents | 2018-04 | 2020-06 |