Efficacy and safety of surfactant administration by MIST and INSURE techniques in Neonates with Respiratory Distress Syndrome: A randomized controlled trial

Ammara Kaleem; Farah Haroon; Bushra Fatima; Gideon Victor; Mazhar Qadir; Khawaja Ahmed Irfan Waheed1

doi:10.12669/pjms.39.3.7283

Ammara Kaleem University of child health sciences Lahore
Farah Haroon University of child health sciences and children's hospital Lahore
Bushra Fatima University of child health sciences and children's hospital Lahore
Gideon Victor Shifa Tameer-e-Millat University, Islamabad
Mazhar Qadir University of child health sciences and children's hospital Lahore
Khawaja Ahmed Irfan Waheed1 University of child health sciences and children's hospital Lahore

DOI: https://doi.org/10.12669/pjms.39.3.7283

Keywords: MIST, INSURE, Neonates, Respiratory distress syndrome, RCT, Surfactant therapy, Preterm. RCT Registration Number: TCTR20210627001

Abstract

Objective: To measure the efficacy and safety of surfactant administered by MIST and INSURE to neonates with respiratory distress syndrome.

Methods: A randomized controlled trial was conducted from June 2021 to August 2022 at the NICU of the University of Child Health Sciences, Lahore. Neonates meeting inclusion criteria i.e with RDS who worsened on nasal Continuous positive airway pressure (nCPAP) (fiO2 30%, pressure 6cmH2O) were enrolled in the study in both interventional arms (MIST, n=36 and INSURE, n=36) using simple random sampling. Data was analysed using SPSS 25.

Results: The mean age of neonates in MIST was 1.27±0.40 days and 1.23±0.48 days in INSURE cohort. Neonates with MIST (n=8) required statistically significant reduced need for IMV than INSURE (n=17) technique (P-Value 0.047). This study could not achieve significant difference in duration of mechanical ventilation (1±1.67; 1.52±1.40 days, P=0.152) and duration of nCPAP (3.27±1.65;3.67±1.64 hrs, P=0.312) in MIST versus INSURE. The second dose of surfactant was administered in fewer cases in MIST (n=2) than INSURE (n=7) (P=0.075). Risk estimation, although not significant, determined less likelihood for the pulmonary haemorrhage (0.908 than 1.095), intraventricular hemorrhage (0.657 than 1.353), administration of the second dose of surfactant (0.412 than 1.690) and greater likelihood of discharge (1.082 than 0.270) at 95% confidence interval with MIST technique.

Conclusion: Surfactant therapy through MIST is effective and there is significantly reduced need of IMV than in INSURE. Safety profile though could not achieve statistical significance yet determines less risk of complications associated with MIST than INSURE.

doi: https://doi.org/10.12669/pjms.39.3.7283

How to cite this: Kaleem A, Haroon F, Fatima B, Victor G, Qadir M, Waheed KAI. Efficacy and safety of surfactant administration by MIST and INSURE techniques in Neonates with Respiratory Distress Syndrome: A randomized controlled trial. Pak J Med Sci. 2023;39(3):848-852. doi: https://doi.org/10.12669/pjms.39.3.7283

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Author Biographies

Farah Haroon, University of child health sciences and children's hospital Lahore

Associate professor and Head of Department

Department of Neonatology

Bushra Fatima, University of child health sciences and children's hospital Lahore

Assistant Professor of Neonatology

Gideon Victor, Shifa Tameer-e-Millat University, Islamabad

Assistant Professor of Medical education

Mazhar Qadir, University of child health sciences and children's hospital Lahore

Assistant Professor of Neonatology

Khawaja Ahmed Irfan Waheed1, University of child health sciences and children's hospital Lahore

Professor of Neonatology