Background and aims Although sedation for endotracheal intubation of infants is widely adopted, there is no consensus whether sedation should be used for minimal invasive surfactant therapy (MIST). We compared, in a randomised controlled setting, the level of stress and comfort of preterm infants during MIST with and without receiving low-dose sedation.
Methods Infants between 26 and 36 weeks gestational age were randomised to receive either low-dose sedation (1 mg/kg propofol intravenous) or no premedication during MIST procedure. Standard comfort care was given in both groups, which consisted of administering sucrose in the cheek pouch of the infant and containment. Primary end point was the percentage of infants assessed to be comfortable during the procedure (COMFORTneo-score <14). Secondary parameters included complications of both the MIST procedure and low-dose sedation administration.
Results In total, 78 infants were randomised and analysed, with a median (IQR) gestational age of 29+0 (28+0–32+0) weeks. The percentage of infants with a COMFORTneo score <14 during MIST was significantly higher in the sedated group (32/42 (76%) vs 8/36 (22%), p<0.001). The incidence of desaturation (SpO2 <85%) during the procedure was significantly higher in the sedated group (38/42 (91%) vs 25/36 (69%), p=0.023), and infants needed more often nasal intermittent mandatory ventilation during the procedure (39/42 (93%) vs 17/36 (47%), p<0.001). There were no differences in incidence of hypotension, bradycardia, intubation or pneumothoraxes.
Conclusion Low-dose sedation increased comfort during MIST procedure in preterm infants, but the need for transient non-invasive ventilation was increased.
Trial registration number NTR5010, pre-results.
- preterm infant
- minimal invasive
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Contributors JD was the executive researcher of this study. She performed literature search, data collection, data analysis, data interpretation, writing and submitting of the report. EL was involved in funding, study design, data interpretation and critical revision of the report. HAvZ was involved in data collection and critical revision of the report. RNGBT was involved in data interpretation and critical revision of the report. SBH was involved in data interpretation and critical revision of the report. AbtP was the project leader and performed literature search, designed the study, and coordinated data analysis, data interpretation, writing and editing of the report. All authors gave approval for the final version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of a part of the work are appropriately investigated and resolved.
Funding Both Chiesi Pharmaceuticals and the Leiden University Fund (LUF) provided an unrestricted grant for the project.
Disclaimer Both Chiesi Pharmaceuticals and the LUF had no role in study design; collection, analysis and interpretation of data; writing of the report; and decision to submit the paper for publication.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The ethical committee of the LUMC approved the study protocol.
Provenance and peer review Not commissioned; externally peer reviewed.