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Published on: January 27, 2019
The effect of routine probiotics supplementation on preterm newborn health: a regression discontinuity analysis
Christian Bommer1,2, Sebastian Horn3, Sebastian Vollmer1
1Centre for Modern Indian Studies, University of Goettingen, Goettingen, Germany.
Insights
Routine probiotics supplementation for moderately preterm newborns did not significantly improve growth or reduce sepsis risk. This study found no evidence to support the widespread use of probiotics in this vulnerable population.
Area of Science:
- Neonatal care
- Pediatric gastroenterology
- Microbiome research
Background:
- Limited rigorous evidence exists on probiotic use in routine preterm newborn care.
- Ongoing debate surrounds the health impacts of probiotics.
Purpose of the Study:
- To estimate the causal effect of routine probiotics supplementation on anthropometric development (weight-for-age and height-for-age z scores) in moderately preterm newborns.
- To assess the impact of probiotics on the risk of late-onset sepsis in this population.
Main Methods:
- Regression discontinuity analysis utilizing hospital guidelines for probiotics.
- Inclusion of 1734 preterm neonates (born 30-38 weeks gestation) from a German neonatal care center (2013-2019).
- Outcomes measured: weight-for-age z scores, length-for-age z scores at discharge, and late-onset sepsis incidence.
Main Results:
- No significant intention-to-treat effect observed for weight-for-age, length-for-age, or late-onset sepsis probability.
- Local average treatment effect analysis also showed no significant impact of probiotics on study endpoints.
- Sepsis risk was low and not significantly altered by probiotic supplementation.
Conclusions:
- Routine probiotics are unlikely to enhance anthropometric outcomes in moderately preterm infants.
- The study findings do not support the routine administration of probiotics for growth promotion or sepsis prevention in this cohort.
- Absence of significant health effects, rather than poor compliance, likely explains the results.
Background:
Despite ongoing debate about the health impact of probiotics, rigorous evidence assessing the use of probiotics in routine preterm newborn care is lacking.
Objectives:
We aimed to estimate the causal effect of routine probiotics supplementation on moderately preterm newborns' anthropometric development (weight-for-age and height-for-age z scores) and risk of late-onset sepsis.
Methods:
This study used a regression discontinuity analysis based on hospital guidelines that recommended routine probiotics supplementation for neonates born before 34 completed weeks of gestation. Data for this study came from electronic medical records of a level III neonatal care center in Germany and were collected between 2013 and 2019. Newborns born between 30 to 38 completed weeks of gestation without severe congenital defects were eligible for inclusion. Outcomes were weight-for-age and height-for-age z scores at discharge as well as late-onset sepsis.
Results:
Study participants included 1734 preterm neonates. The results showed no significant intention-to-treat effect on weight-for-age (effect: -0.033 SD; 95% CI: -0.220, 0.155), length-for-age (-0.133 SD; 95% CI: -0.380, 0.114), or late-onset sepsis probability (-1.175 percentage points; 95% CI: -6.556, 4.205). There was no evidence for significant effects of probiotics for any of the study's endpoints on those complying with the hospital guidelines (local average treatment effect).
Conclusions:
Routine treatment of moderately preterm newborns with probiotics is unlikely to improve anthropometric outcomes. Complier-level analysis suggested that this finding was not simply driven by a lack of physician compliance with hospital guidelines but by an overall absence of large health effects from the treatment itself. Moreover, overall sepsis risk was low and did not change significantly as a result of probiotics supplementation. The findings of this study therefore do not support the routine use of probiotics for improving growth or preventing late-onset sepsis in moderately preterm neonates.
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