Phase 2
Completed N=134
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Feeding; Difficult, Newborn · Growth Failure · Necrotizing Enterocolitis · Sepsis
Source: ClinicalTrials.gov NCT01603368 ↗
Enrolled (actual)
134
Serious AEs
79.9%
Results posted
Apr 2020
Primary outcomePrimary: Time to Establish Full Enteral Feeds — 15; 15 days
Summary
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition.
The aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Establish Full Enteral Feeds |
15; 15 | — |
| SECONDARY Days With Halted Feeding Due to Food Intolerance |
5.5; 6 | — |
| SECONDARY Number of Stools |
69.6; 69.9 | — |
| SECONDARY Time Until Birth Weight is Regained. Specifies the Number of Full Days the Child Has Lived. |
— | — |
| SECONDARY Weight Gain (SD) |
-0.40; -0.24 | — |
| SECONDARY Mortality |
5; 5 | — |
| SECONDARY Necrotizing Enterocolitis |
7; 8 | — |
| SECONDARY Sepsis |
25; 23 | — |
| SECONDARY Bronchopulmonary Dysplasia |
40; 39 | — |
| SECONDARY Length Gain (SD) |
-1.44; -1.34 | — |
| SECONDARY Head Circumference Growth (SD) |
-0.57; -0.79 | — |
| SECONDARY Neurological Development |
— | — |
| SECONDARY Neurological Development Impairment |
— | — |
Eligibility Criteria
Inclusion Criteria
- Birth weight < 1000 g
- Gestational age: v23+0-V27 +6.
- Age < 72 hours at inclusion.
- Signed informed consent by parents.
Exclusion Criteria
- Fatal or complex congenital malformation at inclusion time.
- Chromosomal defect at inclusion time.
- No realistic hope of survival at inclusion time.
- Gastrointestinal malformation at inclusion time.
- Participation in another study which aims to influence nutrition, growth, feeding tolerance or necrotizing enterocolitis.
Data sourced from ClinicalTrials.gov (NCT01603368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.