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Surfactant for pulmonary haemorrhage in neonates
1William Osler Health Centre, Department of Pediatrics, 20 Lynch Street, Brampton, ON, Canada, L6W 2Z8.
Insights
No randomized trials were found to evaluate surfactant treatment for pulmonary haemorrhage (PH) in neonates. Further research is needed to confirm promising results from less rigorous studies on this condition.
Area of Science:
- Neonatal Medicine
- Respiratory Physiology
- Clinical Trials
Background:
- Pulmonary haemorrhage (PH) incidence has shifted from term to preterm infants with severe respiratory distress syndrome (RDS).
- Risk factors include prematurity, severe RDS, patent ductus arteriosus (PDA), and assisted ventilation.
- Surfactant therapy has shown promising results in case reports and uncontrolled studies for PH treatment.
Purpose of the Study:
- To evaluate the efficacy of surfactant treatment versus placebo or no intervention for neonatal pulmonary haemorrhage (PH).
- To assess the impact of surfactant on mortality and morbidities in neonates with PH.
Main Methods:
- Searched multiple databases (MEDLINE, EMBASE, CINAHL, etc.) and clinical trial registries up to February 2012.
- Included randomized or quasi-randomized controlled trials of surfactant for PH in intubated neonates (<37 weeks gestation).
- Planned meta-analysis using risk ratios and mean differences, with fixed-effect models and bias assessment.
Main Results:
- No randomized or quasi-randomized controlled trials evaluating surfactant for pulmonary haemorrhage (PH) were identified.
- Consequently, no conclusions regarding surfactant's efficacy in treating PH could be drawn from high-quality evidence.
Conclusions:
- The absence of randomized controlled trials (RCTs) prevents definitive conclusions on surfactant's effectiveness for neonatal PH.
- Promising results from observational studies warrant further high-quality RCTs to establish surfactant's role in PH treatment.
Background:
In the 1960s and 1970s, pulmonary haemorrhage (PH) occurred mainly in full-term infants with pre-existing illness with an incidence of 1.3 per 1000 live births. Risk factors for PH included severity of illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy and the need for assisted ventilation. Presently, PH occurs in 3% to 5% of preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. The cause of PH is thought to be due to rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a PDA and an increase in pulmonary blood flow. Retrospective case reports and one prospective uncontrolled study have shown promising results for surfactant in treating PH.
Objectives:
To evaluate the effect of surfactant treatment compared to placebo or no intervention on mortality and morbidities in neonates with PH.
Search Methods:
For this update The Cochrane Library, Issue 2, 2012; MEDLINE; EMBASE; CINAHL; Clinicaltrials.gov; Controlled-trials.com; proceedings (2000 to 2011) of the Annual Meetings of the Pediatric Academic Societies (Abstracts2View) and Web of Science were searched on 8 February 2012.
Selection Criteria:
Randomised or quasi-randomised controlled trials that evaluated the effect of surfactant in the treatment of PH in intubated term or preterm (< 37 weeks) neonates with PH. Infants were included up to 44 weeks' postmenstrual age. The interventions studied were intratracheal instillation of surfactant (natural or synthetic, regardless of dose) versus placebo or no intervention.
Data Collection And Analysis:
If studies were identified by the literature search, the planned analyses included risk ratio, risk difference, number needed to treat to benefit or to harm for dichotomous outcomes, and mean difference for continuous outcomes, with their 95% confidence intervals. A fixed-effect model would be used for meta-analyses. The risk of bias for included trials would be assessed. Heterogeneity tests, including the I2 statistic, would be performed to assess the appropriateness of pooling the data and the results would be reported.
Main Results:
No trials were identified.
Authors' Conclusions:
No randomised or quasi-randomised trials that evaluated the effect of surfactant in PH were identified. Therefore, no conclusions from such trials can be drawn. In view of the promising results from studies with less strict study designs than a randomised controlled trial, there is reason to conduct further trials of surfactant for the treatment of PH in neonates.
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