Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-28
SponsorRegion Stockholm
About this trial
The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely preterm (EPT) infants born before gestational week 28.
P: The study population include EPT infants (n= 1620) born at six tertiary neonatal units in Sweden and four units in Denmark.
I: This is a double-blinded multicenter randomized controlled trial where infants in the intervention group will as soon as they tolerate 3 mL breastmilk per feed receive a probiotic combination of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus diluted in 3 mL breastmilk and given once daily until gestational week 34.
C: The control group will receive 3 mL breastmilk without probiotic supplementation (blinded) daily.
O: Primary outcome variables is a composite endpoint of incidence of NEC and mortality. Secondary outcomes include incidence of sepsis, duration of hospital stay, use of antibiotics, feeding tolerance, growth, and body composition after hospital discharge.
Patient benefit: To provide evidence on the usage of probiotics among EPT infants that are not currently covered by clinical recommendations. As EPT infants have the highest risk for NEC and mortality our results have the potential to change current recommendations and improve patient outcomes, decrease mortality, shorten hospitalization, and decrease overall health-care costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with severe complications and low chance of survival detected wihin the first 72 hours of life
Patients with major congenital-anomalies
Patients included in other interventional trials with the same or overlapping oucome measures.
Trial design
Design model
Parallel
Treatments tested in this trial
ProPrems
Dietary supplementThe intervention product, commercially known as ProPrems®, is a combination of (one billion freeze-dried bacteria per 0.5 g in a maltodextrin base powder: Bifidobacterium infantis Bb-02 (DSM 33361) 300 million, Bifidobacterium lactis (BB-12®) 350 million, and Streptococcus thermophilus (TH-4®) 350 million will be given daily once to eligable infants born extremly preterm (\<28weeks of gestation) once they tolerate 3ml of enterla feeds until the age of 34 weeks of gestation.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Probiotic groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Necrotizing enterocolitis (NEC)
verified NEC \>/= Bell sage II
Time frame
Depending on gestational age at birth (22+0 wGA - 27+6 wGA) up to the end of intervention at 34 w GA + 2 weeks. This gives a time frame of 8-14 weeks.2
Death
Time frame
Depending on gestational age at birth (22+0 wGA - 27+6 wGA) up to the end of intervention at 34 w GA + 2 weeks. This gives a time frame of 8-14 weeksSecondary outcomes
1
Sepsis
defined as blood culture proven sepsis and/or laboratory inflammatory response were at least one of the following must be confirmed: 1. LPK \< 5 or \> 20 (x109 cells/L) 2. TPK \< 100 (x109 cells/L) 3. CRP \> 15 mg/L
Time frame
Depending on gestational age at birth (22+0 wGA - 27+6 wGA) up to the end of intervention at 34 w GA + 2 weeks. This gives a time frame of 8-14 weeks2
Anibiotic use
Duration of antibiotic use
Time frame
Depending on gestational age at birth (22+0 wGA - 27+6 wGA) up to the end of intervention at 34 w GA + 2 weeks. This gives a time frame of 8-14 weeks3
Anibiotic use
Frequency of antibiotic use (how often have antibiotics been started during the time frame)
Time frame
Depending on gestational age at birth (22+0 wGA - 27+6 wGA) up to the end of intervention at 34 w GA + 2 weeks. This gives a time frame of 8-14 weeks4
Feeding intolerance
incidence of enteral feeding intolerance defined as gasric residuals, distended abdomen, emesis
Time frame
Depending on gestational age at birth (22+0 wGA - 27+6 wGA) up to the end of intervention at 34 w GA + 2 weeks. This gives a time frame of 8-14 weeksSponsors and contacts
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Source ClinicalTrials.gov