Preterm neonates with respiratory distress syndrome (RDS) are commonly treated with surfactant by intubate surfactant extubate (InSurE) technique. Less invasive surfactant administration (LISA) is also being used as mode of surfactant delivery. The surfactant used in most of LISA technique is smaller volume poractant-alfa. We aim to compare InSurE versus LISA technique using more economical but higher volume (Bovine) surfactant and non-invasive positive pressure ventilation (NIPPV) as mode of support in low and middle income country settings. We randomised 100 preterm infants of 26–34 weeks of gestation with RDS within 6 h of birth to receive bovine lipid extract surfactant (100 mg/kg) by InSurE or LISA mode. NIPPV was used as primary mode of respiratory support. The primary objective was to compare the need of invasive mechanical ventilation (IMV) in first 72 h of life and secondary outcomes assessed were hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade II), bronchopulmonary dysplasia (BPD), episodes of bradycardia/desaturation, pulmonary haemorrhage and composite outcome of BPD/mortality. Out of the 100 neonates enrolled, 50 were randomized to the InSurE group and 50 to the LISA group. The mean gestational age and birth weight were 30.59 ± 2.19 weeks and 1.27 ± 0.41 kg in the InSurE group, and 30.53 ± 0.31 weeks and 1.26 ± 0.31 kg in the LISA group respectively. Insignificant statistical difference was seen in the need of IMV in first 72 h between LISA and InSurE (14/50 (28%) vs 15/50 (30%), p = 0.86). Additionally, there were no significant differences in the incidence of hsPDA, IVH (> grade 2), BPD, episodes of bradycardia/desaturation, pulmonary haemorrhage, and composite outcome of BPD/mortality.Conclusion: LISA and InSurE are equally feasible strategies for surfactant administration in the treatment of neonatal RDS using NIPPV as primary respiratory support. Both groups had comparable outcomes using larger volume, cost effective bovine lipid extract surfactant with no added advantage of LISA as compared to InSurE technique.Trial registration: CTRI (CTRI/2021/08/035649) dated 13/08/21.<Table Float="No" ID="Taba"> <tgroup cols="1"> <colspec align="left" colname="c1" colnum="1" /> <tbody> <row> <entry align="left" colname="c1"> What is Known: • Most existing studies have employed more expensive, lower-volume surfactants for less invasive surfactant administration in neonates with nCPAP as primary mode of support. </entry> </row> <row> <entry align="left" colname="c1"> What is New: • LISA technique using more economical but higher volume (Bovine) surfactant (5 ml/kg) and Non-invasive positive pressure ventilation (NIPPV) as primary mode of respiratory support for RDS showed similar outcomes with no added advantage of LISA as compared to InSure Technique. LISA technique with higher volume and economical surfactant is well feasible using NIPPV as respiratory support. </entry> </row> </tbody> </tgroup> </Table>

Less Invasive Surfactant Administration (LISA) versus Intubation Surfactant Extubation (InSurE) technique using higher volume surfactant in management of neonates with respiratory distress syndrome: an open-label randomized controlled trial

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发表日期：

2025年5月29日

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Saamic Hooda,
Jagjit Singh Dalal,
Kapil Bhalla,
N. D. Vaswani,
Monika Dalal

摘要

Preterm neonates with respiratory distress syndrome (RDS) are commonly treated with surfactant by intubate surfactant extubate (InSurE) technique. Less invasive surfactant administration (LISA) is also being used as mode of surfactant delivery. The surfactant used in most of LISA technique is smaller volume poractant-alfa. We aim to compare InSurE versus LISA technique using more economical but higher volume (Bovine) surfactant and non-invasive positive pressure ventilation (NIPPV) as mode of support in low and middle income country settings. We randomised 100 preterm infants of 26–34 weeks of gestation with RDS within 6 h of birth to receive bovine lipid extract surfactant (100 mg/kg) by InSurE or LISA mode. NIPPV was used as primary mode of respiratory support. The primary objective was to compare the need of invasive mechanical ventilation (IMV) in first 72 h of life and secondary outcomes assessed were hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade II), bronchopulmonary dysplasia (BPD), episodes of bradycardia/desaturation, pulmonary haemorrhage and composite outcome of BPD/mortality. Out of the 100 neonates enrolled, 50 were randomized to the InSurE group and 50 to the LISA group. The mean gestational age and birth weight were 30.59 ± 2.19 weeks and 1.27 ± 0.41 kg in the InSurE group, and 30.53 ± 0.31 weeks and 1.26 ± 0.31 kg in the LISA group respectively. Insignificant statistical difference was seen in the need of IMV in first 72 h between LISA and InSurE (14/50 (28%) vs 15/50 (30%), p = 0.86). Additionally, there were no significant differences in the incidence of hsPDA, IVH (> grade 2), BPD, episodes of bradycardia/desaturation, pulmonary haemorrhage, and composite outcome of BPD/mortality.

Conclusion: LISA and InSurE are equally feasible strategies for surfactant administration in the treatment of neonatal RDS using NIPPV as primary respiratory support. Both groups had comparable outcomes using larger volume, cost effective bovine lipid extract surfactant with no added advantage of LISA as compared to InSurE technique.

Trial registration: CTRI (CTRI/2021/08/035649) dated 13/08/21.

What is Known:

• Most existing studies have employed more expensive, lower-volume surfactants for less invasive surfactant administration in neonates with nCPAP as primary mode of support.

What is New:

• LISA technique using more economical but higher volume (Bovine) surfactant (5 ml/kg) and Non-invasive positive pressure ventilation (NIPPV) as primary mode of respiratory support for RDS showed similar outcomes with no added advantage of LISA as compared to InSure Technique. LISA technique with higher volume and economical surfactant is well feasible using NIPPV as respiratory support.