A Randomized Controlled Trial of Probiotic Intervention for Reducing the Risk of Bronchopulmonary Dysplasia in Preterm Infants.

2026-07
Archives of medical research 57(5)
- Dandan Wang
- Shanshan Wang
- Huijie Wang
- Xuan Zhang

PubMed: 41895129
DOI: 10.1016/j.arcmed.2026.103408

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 244
Population: 244 preterm infants with gestational ages of <32 weeks and birth weights of <1,500 g
Methods: randomly assigned to intervention group (n=122) or control (n=122); intervention received a combination of Clostridium butyricum and Bifidobacterium infantis starting 24 h after birth until 36 weeks corrected gestational age; both groups received conventional treatment
Duration: from 24 hours after birth until 36 weeks corrected gestational age

Large Human Trial

Background

The benefits of probiotics for preterm infants remain largely unexplored. This randomized controlled trial establishes bronchopulmonary dysplasia (BPD) as the primary endpoint and investigates the protective effect of probiotic intervention against the development of BPD in this population.

Methods

A total of 244 preterm infants with gestational ages of <32 weeks and birth weights of <1,500 g were consecutively enrolled. The infants were randomly assigned to either an intervention group (n = 122) or a control group (n = 122). Those in the intervention group received probiotic intervention (a combination of Clostridium butyricum and Bifidobacterium infantis) starting 24 h after birth and continuing until they reached 36 weeks corrected gestational age. In addition, preterm infants in both groups received conventional treatment. BPD occurrence was assessed at 36 weeks corrected gestational age. Complications of BPD were evaluated at 12 months of corrected gestational age. Multivariate logistic regression was used for data analysis.

Results

Compared with the control group, the probiotic intervention was associated with a reduced incidence of BPD and a lower proportion of severe BPD cases in the intervention group. The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70, among preterm infants with BPD in the intervention group.

Conclusion

Probiotic intervention may reduce the risk, severity, and complications of BPD in preterm infants.

Research Insights

Bifidobacterium infantis→Reduced Bronchopulmonary Dysplasia Incidence
Compared with the control group, the probiotic intervention was associated with a reduced incidence of BPD
Effect
Beneficial
Effect size
Small
Bifidobacterium infantis→Reduced Bronchopulmonary Dysplasia Severity
a lower proportion of severe BPD cases in the intervention group
Effect
Beneficial
Effect size
Small
Bifidobacterium infantis→Reduced Neurodevelopmental Delay
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small
Bifidobacterium infantis→Reduced Oxygen Dependency
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small
Bifidobacterium infantis→Reduced Pulmonary Artery Hypertension
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small
Bifidobacterium infantis→Reduced Underweight
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small
Clostridium butyricum→Reduced Bronchopulmonary Dysplasia Incidence
Compared with the control group, the probiotic intervention was associated with a reduced incidence of BPD
Effect
Beneficial
Effect size
Small
Clostridium butyricum→Reduced Bronchopulmonary Dysplasia Severity
a lower proportion of severe BPD cases in the intervention group
Effect
Beneficial
Effect size
Small
Clostridium butyricum→Reduced Neurodevelopmental Delay
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small
Clostridium butyricum→Reduced Oxygen Dependency
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small
Clostridium butyricum→Reduced Pulmonary Artery Hypertension
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small
Clostridium butyricum→Reduced Underweight
The intervention was also linked to a lower proportion of abnormal outcomes, including oxygen dependency at 12 months, pulmonary artery systolic pressure >30 mmHg, weight less than 2 standard deviations below the WHO standards at 12 months corrected age, and a Bayley-III score <70
Effect
Beneficial
Effect size
Small