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Meta-Analysis
. 2021 May 10;5(5):CD011672.
doi: 10.1002/14651858.CD011672.pub2.

Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome

Mohamed E Abdel-Latif  1   2   3 , Peter G Davis  4   5   6 , Kevin I Wheeler  5   7   8 , Antonio G De Paoli  9 , Peter A Dargaville  9   10
Affiliations
Meta-Analysis

Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome

Mohamed E Abdel-Latif et al. Cochrane Database Syst Rev. .

Abstract

Background: Non-invasive respiratory support is increasingly used for the management of respiratory dysfunction in preterm infants. This approach runs the risk of under-treating those with respiratory distress syndrome (RDS), for whom surfactant administration is of paramount importance. Several techniques of minimally invasive surfactant therapy have been described. This review focuses on surfactant administration to spontaneously breathing infants via a thin catheter briefly inserted into the trachea.

Objectives: Primary objectives In non-intubated preterm infants with established RDS or at risk of developing RDS to compare surfactant administration via thin catheter with: 1. intubation and surfactant administration through an endotracheal tube (ETT); or 2. continuation of non-invasive respiratory support without surfactant administration or intubation. Secondary objective 1. To compare different methods of surfactant administration via thin catheter Planned subgroup analyses included gestational age, timing of intervention, and use of sedating pre-medication during the intervention.

Search methods: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 30 September 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.

Selection criteria: We included randomised trials comparing surfactant administration via thin catheter (S-TC) with (1) surfactant administration through an ETT (S-ETT), or (2) continuation of non-invasive respiratory support without surfactant administration or intubation. We also included trials comparing different methods/strategies of surfactant administration via thin catheter. We included preterm infants (at < 37 weeks' gestation) with or at risk of RDS.

Data collection and analysis: Review authors independently assessed study quality and risk of bias and extracted data. Authors of all studies were contacted regarding study design and/or missing or unpublished data. We used the GRADE approach to assess the certainty of evidence.

Main results: We included 16 studies (18 publications; 2164 neonates) in this review. These studies compared surfactant administration via thin catheter with surfactant administration through an ETT with early extubation (Intubate, Surfactant, Extubate technique - InSurE) (12 studies) or with delayed extubation (2 studies), or with continuation of continuous positive airway pressure (CPAP) and rescue surfactant administration at pre-specified criteria (1 study), or compared different strategies of surfactant administration via thin catheter (1 study). Two trials reported neurosensory outcomes of of surviving participants at two years of age. Eight studies were of moderate certainty with low risk of bias, and eight studies were of lower certainty with unclear risk of bias. S-TC versus S-ETT in preterm infants with or at risk of RDS Meta-analyses of 14 studies in which S-TC was compared with S-ETT as a control demonstrated a significant decrease in risk of the composite outcome of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age (risk ratio (RR) 0.59, 95% confidence interval (CI) 0.48 to 0.73; risk difference (RD) -0.11, 95% CI -0.15 to -0.07; number needed to treat for an additional beneficial outcome (NNTB) 9, 95% CI 7 to 16; 10 studies; 1324 infants; moderate-certainty evidence); the need for intubation within 72 hours (RR 0.63, 95% CI 0.54 to 0.74; RD -0.14, 95% CI -0.18 to -0.09; NNTB 8, 95% CI; 6 to 12; 12 studies, 1422 infants; moderate-certainty evidence); severe intraventricular haemorrhage (RR 0.63, 95% CI 0.42 to 0.96; RD -0.04, 95% CI -0.08 to -0.00; NNTB 22, 95% CI 12 to 193; 5 studies, 857 infants; low-certainty evidence); death during first hospitalisation (RR 0.63, 95% CI 0.47 to 0.84; RD -0.02, 95% CI -0.10 to 0.06; NNTB 20, 95% CI 12 to 58; 11 studies, 1424 infants; low-certainty evidence); and BPD among survivors (RR 0.57, 95% CI 0.45 to 0.74; RD -0.08, 95% CI -0.11 to -0.04; NNTB 13, 95% CI 9 to 24; 11 studies, 1567 infants; moderate-certainty evidence). There was no significant difference in risk of air leak requiring drainage (RR 0.58, 95% CI 0.33 to 1.02; RD -0.03, 95% CI -0.05 to 0.00; 6 studies, 1036 infants; low-certainty evidence). None of the studies reported on the outcome of death or survival with neurosensory disability. Only one trial compared surfactant delivery via thin catheter with continuation of CPAP, and one trial compared different strategies of surfactant delivery via thin catheter, precluding meta-analysis.

Authors' conclusions: Administration of surfactant via thin catheter compared with administration via an ETT is associated with reduced risk of death or BPD, less intubation in the first 72 hours, and reduced incidence of major complications and in-hospital mortality. This procedure had a similar rate of adverse effects as surfactant administration through an ETT. Data suggest that treatment with surfactant via thin catheter may be preferable to surfactant therapy by ETT. Further well-designed studies of adequate size and power, as well as ongoing studies, will help confirm and refine these findings, clarify whether surfactant therapy via thin tracheal catheter provides benefits over continuation of non-invasive respiratory support without surfactant, address uncertainties within important subgroups, and clarify the role of sedation.

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Conflict of interest statement

MEA has no interests to declare.

KIW has no interests to declare.

PGD has no interests to declare.

AGDP has no interests to declare.

PAD is the Chief Investigator of the OPTIMIST‐A trial, a multi‐centre RCT of surfactant via tracheal catheterisation in preterm infants on CPAP (ACTRN12611000916943). Chiesi Farmaceutici (Parma, Italy) is providing in‐kind support for this trial by providing surfactant at reduced cost for the OPTIMIST‐A trial. Dr. Dargaville has served as a consultant for Chiesi Farmaceutici and AbbVie Inc. Neither company is involved with the protocol, analysis, manuscript preparation, or publication processes of this review. The Australian National Health and Medical Research Council (NHMRC) has awarded a project grant (#1049114) for conduct of an RCT of minimally invasive surfactant therapy in preterm infants on CPAP, for which PAD is the Chief Investigator.

Figures

1
1
Study flow diagram.
2
2
Primary and follow‐up studies included in the review categorised by comparison group.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
5
5
Forest plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.1 Death or BPD.
6
6
Funnel plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.1 Death or BPD.
7
7
Forest plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.2 Need for intubation within the first 72 hours.
8
8
Funnel plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.2 Need for intubation within the first 72 hours.
9
9
Forest plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.3 Air leak requiring drainage.
10
10
Forest plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.4 Severe IVH.
11
11
Forest plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.5 Death during first hospitalisation.
12
12
Funnel plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.5 Death during first hospitalisation.
13
13
Forest plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.6 BPD (clinical definition); in survivors to 36 weeks' PMA.
14
14
Funnel plot of comparison: 1 Trials comparing S‐TC with S‐ETT ‐ overall analysis, outcome: 1.6 BPD (clinical definition); in survivors to 36 weeks' PMA.
1.1
1.1. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 1: Death or BPD
1.2
1.2. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 2: Need for intubation within the first 72 hours
1.3
1.3. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 3: Air leak requiring drainage
1.4
1.4. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 4: Severe IVH
1.5
1.5. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 5: Death during first hospitalisation
1.6
1.6. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 6: BPD (clinical definition); in survivors to 36 weeks' PMA
1.7
1.7. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 7: Catheter/ETT placement unsuccessful at first attempt
1.8
1.8. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 8: Bradycardia (heart rate < 100 bpm) during the intervention
1.9
1.9. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 9: Hypoxaemia (oxygen saturation < 80%) during the intervention
1.10
1.10. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 10: Need for intubation within the first 72 hours or not intubated but reached failure criteria
1.11
1.11. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 11: Need for intubation at any time
1.12
1.12. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 12: Need for intratracheal surfactant therapy post intervention
1.13
1.13. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 13: Duration of mechanical ventilation (days; in survivors)
1.14
1.14. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 14: Duration of any respiratory support (days; in survivors)
1.15
1.15. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 15: Duration of oxygen therapy (days; in survivors)
1.16
1.16. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 16: Postnatal systemic corticosteroid therapy for BPD mitigation
1.17
1.17. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 17: BPD (physiological definition)
1.18
1.18. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 18: IVH, any grade
1.19
1.19. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 19: Cystic PVL
1.20
1.20. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 20: PDA requiring medical therapy
1.21
1.21. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 21: NEC, modified Bell stage ≥2
1.22
1.22. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 22: ROP stage ≥ 3
1.23
1.23. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 23: Duration of hospitalisation (days; in survivors)
1.24
1.24. Analysis
Comparison 1: Trials comparing S‐TC with S‐ETT ‐ overall analysis, Outcome 24: Discharged home with oxygen
2.1
2.1. Analysis
Comparison 2: Trials comparing S‐TC with S‐ETT ‐ sub‐group analyses, Outcome 1: Death or BPD
3.1
3.1. Analysis
Comparison 3: Trials comparing S‐TC with S‐ETT ‐ sensitivity analysis, Outcome 1: Death or BPD
3.2
3.2. Analysis
Comparison 3: Trials comparing S‐TC with S‐ETT ‐ sensitivity analysis, Outcome 2: Need for intubation within the first 72 hours
3.3
3.3. Analysis
Comparison 3: Trials comparing S‐TC with S‐ETT ‐ sensitivity analysis, Outcome 3: Air leak requiring drainage
3.4
3.4. Analysis
Comparison 3: Trials comparing S‐TC with S‐ETT ‐ sensitivity analysis, Outcome 4: Severe IVH
3.5
3.5. Analysis
Comparison 3: Trials comparing S‐TC with S‐ETT ‐ sensitivity analysis, Outcome 5: Death during first hospitalisation
3.6
3.6. Analysis
Comparison 3: Trials comparing S‐TC with S‐ETT ‐ sensitivity analysis, Outcome 6: BPD (clinical definition); in survivors to 36 weeks' PMA
4.1
4.1. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 1: Death or BPD
4.2
4.2. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 2: Incidence of air leak requiring drainage
4.3
4.3. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 3: Severe IVH
4.4
4.4. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 4: Death during first hospitalisation
4.5
4.5. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 5: BPD (clinical definition); in survivors to 36 weeks' PMA
4.6
4.6. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 6: Catheter/ETT placement unsuccessful at first attempt
4.7
4.7. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 7: Bradycardia (heart rate < 100 bpm) during the intervention
4.8
4.8. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 8: Need for intubation within the first 72 hours or not intubated but reached failure criteria
4.9
4.9. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 9: Need for intubation at any time
4.10
4.10. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 10: Postnatal systemic corticosteroid therapy for BPD mitigation
4.11
4.11. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 11: Cystic PVL
4.12
4.12. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 12: ROP ≥ stage 3
4.13
4.13. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 13: Discharged home with oxygen
4.14
4.14. Analysis
Comparison 4: Trials comparing S‐TC with continuation of non‐invasive support ‐ overall analysis, Outcome 14: Cerebral palsy by clinical examination or other means
5.1
5.1. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 1: Air leak
5.2
5.2. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 2: Severe IVH
5.3
5.3. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 3: Need for intubation during the procedure
5.4
5.4. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 4: Need for intubation within the first 24 hours
5.5
5.5. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 5: Death during first hospitalisation
5.6
5.6. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 6: Need for positive‐pressure ventilation during the intervention
5.7
5.7. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 7: Duration of the procedure (seconds)
5.8
5.8. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 8: Pain score using a validated instrument for measuring discomfort/pain during the procedure (e.g. COMFORTneo score)
5.9
5.9. Analysis
Comparison 5: Trials comparing different methods of surfactant delivery via thin catheter ‐ overall analysis, Outcome 9: Hypotension requiring treatment
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Bao 2015 {published and unpublished data}
    1. Bao Y, Zhang G, Wu M, Ma L, Zhu J. A pilot study of less invasive surfactant administration in very preterm infants in a Chinese tertiary center. BMC Pediatrics 2015;15(21):1-6. [DOI: 10.1186/s12887-015-0342-7] [PMID: ] - DOI - PMC - PubMed
Boskabadi 2019 {published data only}
    1. Boskabadi H, Maamouri G, Gharaei Jomeh R, Zakerihamidi M. Comparative study of the effect of the administration of surfactant through a thin endotracheal catheter into trachea during spontaneous breathing with intubation (intubation-surfactant-extubation method). Journal of Clinical Neonatology 2019;8(4):227-31. [DOI: 10.4103/jcn.JCN_32_19] - DOI
Choupani 2018 {published data only}
    1. Choupani R, Mashayekhy G, Hmidi M, Kheiri S, Khalili Dehkordi M. A comparative study of the efficacy of surfactant administration through a thin intratracheal catheter and its administration via an endotracheal tube in neonatal respiratory distress syndrome. Iranian Journal of Neonatology 2018;9(4):33-40. [DOI: 10.22038/ijn.2018.30057.1408] - DOI
Dekker 2019 {published and unpublished data}
    1. Dekker J, Lopriore E, Zanten HA, Tan RN, Hooper SB, te Pas AB. Sedation during minimal invasive surfactant therapy: a randomised controlled trial (PROMISES). Archives of Disease in Childhood. Fetal and Neonatal Edition 2019;104(4):F378–83. [DOI: 10.1136/archdischild-2018-315015] [PMID: ] - DOI - PubMed
Göpel 2011 {published data only}
    1. Göpel W, Kribs A, Ziegler A, Laux R, Hoehn T, Wieg C, et al, German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants: an open-label, randomised, controlled trial (AMV Trial). Lancet 2011;378(9803):1727-34. [DOI: 10.1016/S0140-6736(11)60986-0] [PMID: ] - DOI - PubMed
    1. Herting E, Kribs A, Härtel C, Wense A, Weller U, Hoehn T, et al, German Neonatal Network (GNN). Two-year outcome data suggest that less invasive surfactant administration (LISA) is safe. Results from the follow-up of the randomized controlled AMV (avoid mechanical ventilation) study. European Journal of Pediatrics 2020;179(8):1309-13. [DOI: 10.1007/s00431-020-03572-0] [PMID: ] - DOI - PMC - PubMed
Gupta 2020 {published data only}
    1. Gupta BK, Saha AK, Mukherjee S, Saha B. Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation - a randomized controlled trial. European Journal of Pediatrics 2020;179(8):1287–93. [DOI: 10.1007/s00431-020-03682-9] [PMID: ] - DOI - PMC - PubMed
Halim 2019 {published data only}
    1. Halim A, Shirazi H, Riaz S, Gul SS, Ali W. Less Invasive surfactant administration in preterm infants with respiratory distress syndrome. Journal of the College of Physicians and Surgeons Pakistan 2019;29(3):226-30. [DOI: 10.29271/jcpsp.2019.03.226] [PMID: ] - DOI - PubMed
Han 2020 {published and unpublished data}
    1. Han T, Liu H, Zhang H, Guo M, Zhang X, Duan Y, et al. Minimally invasive surfactant administration for the treatment of neonatal respiratory distress syndrome: a multicenter randomized study in China. Frontiers in Pediatrics 2020;8(182):1-12. [DOI: 10.3389/fped.2020.00182] [PMID: ] - DOI - PMC - PubMed
Jena 2019 {published and unpublished data}
    1. Jena SR, Bains HS, Pandita A, Verma A, Gupta V, Kallem VR, et al, On Behalf of Sure Group. Surfactant therapy in premature babies: SurE or InSurE. Pediatric Pulmonology 2019;54(11):1747-52. [DOI: ] [PMID: ] - PubMed
Kanmaz 2013 {published and unpublished data}
    1. Kanmaz HG, Erdeve O, Canpolat FE, Mutlu B, Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics 2013;131(2):e502-9. [DOI: 10.1542/peds.2012-0603] [PMID: ] - DOI - PubMed
Kribs 2015 {published data only}
    1. Kribs A, Roll C, Göpel W, Wieg C, Groneck P, Laux R, Teig N, et al, NINSAPP Trial Investigators. Nonintubated surfactant application vs conventional therapy in extremely preterm infants a randomized clinical trial. JAMA Pediatrics 2015;169(8):723-30. [DOI: 10.1001/jamapediatrics.2015.0504] [PMID: ] - DOI - PubMed
    1. Mehler K, Broer A, Roll C, Göpel W, Wieg C, Norbert PJ, et al. Developmental outcome of extremely preterm infants is improved after less invasive surfactant application (LISA). Acta Paediatrica 2020;00:1-8. [DOI: 10.1111/apa.15565] [PMID: ] - DOI - PubMed
Mirnia 2013a {published data only}
    1. Mirnia K, Heidarzadeh M, Hosseini MB, Sadeghnia A, Balila M, Ghojazadeh M. Comparison outcome of surfactant administration via tracheal catheterization during spontaneous breathing with INSURE. Medical Journal of Islamic World Academy of Sciences 2013;21(4):143-8. [DOI: 10.12816/0002647] - DOI
Mohammadizadeh 2015 {published data only}
    1. Mohammadizadeh M, Ardestani AG, Sadeghnia AR. Early administration of surfactant via a thin intratracheal catheter in preterm infants with respiratory distress syndrome: feasibility and outcome. Journal of Research in Pharmacy Practice 2015;4(1):31-6. [DOI: 10.4103/2279-042X.150053] [PMID: ] - DOI - PMC - PubMed
Mosayebi 2017 {published data only}
    1. Mosayebi Z, Kadivar M, Taheri-Derakhsh N, Nariman S, Mahdi Marash Si, Farsi Z. A randomized trial comparing surfactant administration using InSurE technique and the minimally invasive surfactant therapy in preterm infants (28 to 34 weeks of gestation) with respiratory distress syndrome. Journal of Comprehensive Pediatrics 2017;8(4):e60724. [DOI: 10.5812/compreped.60724] - DOI
Olivier 2017 {published and unpublished data}
    1. Olivier F, Nadeau S, Bélanger S, Julien AS, Massé E, Ali N, et al. Efficacy of minimally invasive surfactant therapy in moderate and late preterm infants: a multicentre randomized control trial. Paediatrics & Child Health 2017;22(3):120-4. [DOI: 10.1093/pch/pxx033] [PMID: ] - DOI - PMC - PubMed
Yang 2020 {published and unpublished data}
    1. Yang G, Hei M, Xue Z, Zhao Y, Zhang X, Wang C. Effects of less invasive surfactant administration (LISA) via a gastric tube on the treatment of respiratory distress syndrome in premature infants aged 32 to 36 weeks. Medicine (Baltimore) 2020;99(9):e19216. [DOI: 10.1097/MD.0000000000019216] [PMID: ] - DOI - PMC - PubMed

References to studies excluded from this review

Mirnia 2013b {published data only}
    1. Heidarzadeh M, Mirnia K, Hoseini MB, Sadeghnia A, Akrami F, Balila M, et al. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial in Alzahra Hospital. Iranian Journal of Neonatology 2013;4(2):5-9. [DOI: 10.22038/IJN.2013.1075] [ijn.mums.ac.ir/article_1075.html] - DOI
    1. Mirnia K, Heidarzadeh M, Hoseini MB, Sadeghnia A, Akrami F, Balila M, et al. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial in Alzahra Hospital. Iranian Journal of Neonatology 2013;4(2):5-9. [DOI: 10.22038/IJN.2013.1075] [jn.mums.ac.ir/article_1075.html] - DOI
Oncel 2016 {published data only}
    1. Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, et al. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Archives of Disease in Childhood. Fetal Neonatal Edition 2016;101(4):F323-8. [DOI: 10.1136/archdischild-2015-308204] [PMID: ] - DOI - PubMed

References to ongoing studies

ACTRN12611000916943 {published data only}
    1. ACTRN12611000916943. OPTIMIST-A trial: multicentre randomised controlled trial in preterm infants 25-28 weeks gestation on continuous positive airway pressure of the effect of minimally-invasive surfactant therapy in comparison to standard care (continuation of CPAP) on the incidence of the composite outcome of death or physiological BPD. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336668 (first received 25 August 2011). [https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336668&... (Registered on 26 Aug 2011)]
    1. Dargaville PA, Kamlin CO, De Paoli AG, Carlin JB, Orsini F, Soll RF, et al. The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25–28 weeks gestation. BMC Pediatrics 2014;14:213. [DOI: 10.1186/1471-2431-14-213] [PMID: ] - DOI - PMC - PubMed
    1. NCT02140580. OPTIMIST-A trial: minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on CPAP (OPTIMIST-A) [Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airways pressure]. clinicaltrials.gov/ct2/show/NCT02140580 (first received 16 May 2014).
ACTRN12611000917932 {published data only}
    1. ACTRN12611000917932. The OPTIMIST-B trial: multicentre randomised controlled trial in preterm infants 29-32 weeks gestation on continuous positive airway pressure of the effect of minimally-invasive surfactant therapy in comparison to standard care (continuation of CPAP) on the duration of respiratory support (all hours of intubation, nasal CPAP and high flow nasal cannula). anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343305 (first received 26 August 2011).
ChiCTR1900020970 {published data only}
    1. ChiCTR1900020970. A multicenter clinical randomized controlled study comparing the application of modified minimally invasive pulmonary surfactant and low inspiratory peak pressure supporting pulmonary surfactant instillation technology in the treatment of respiratory distress syndrome in very premature infants. chictr.org.cn/searchproj.aspx?ishtml=sponsorproj&type=cn&institu... (first received 23 January 2019). [DOI: 10.1186/s13063-020-04390-3] - DOI
NCT01615016 {published data only}
    1. NCT01615016. MISurf versus InSurE. A comparison of minimally invasive surfactant application techniques in preterm infants (MIsurf) [Feasibility study of a comparison of minimally invasive surfactant application techniques in preterm infants]. clinicaltrials.gov/ct2/show/NCT01615016 (first received 8 June 2012).
NCT01848262 {published data only}
    1. NCT01848262. ECALMIST versus InSurE in preterm infant < 32 weeks, multicenter, multinational RCT (ECALMIST) [ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant, Extubate) in preterm infants with respiratory distress syndrome (RDS): prospective randomised control clinical trial]. clinicaltrials.gov/ct2/show/NCT01848262 (first received 7 May 2013).
NCT02772081 {published data only}
    1. NCT02772081. An open-label, multicenter, randomized, controlled study in spontaneously breathing preterm neonates with respiratory distress syndrome to compare two procedures for porcine surfactant (poractant alfa, CUROSURF®) administration: a less invasive method (LISA) during non-invasive ventilation (NIV) and the conventional administration during brief invasive ventilation (LISPAP). ClinicalTrials.gov/show/NCT02772081 (first received 13 May 2019).
NCT03989960 {published data only}
    1. NCT03989960. Application of modified intubation-surfactant-extubation (InSurE) technique in preterm neonates with respiratory distress syndrome (MOLISAN). ClinicalTrials.gov/show/NCT03989960 (first received 18 June 2019).
NCT04016246 {published data only}
    1. NCT04016246 Chevallier M, Durrmeyer X, Ego A, Debillon T, the PROLISA Study Group. Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA). BMC Pediatrics 2020;20(100):1-9. [DOI: 10.1186/s12887-020-02112-x] - DOI - PMC - PubMed
    1. NCT04016246. Respiratory effect of the LISA (less invasive surfactant administration) method with sedation by propofol versus absence of sedation: double-blind comparative randomized clinical trial (PROLISA). ClinicalTrials.gov/show/NCT04016246 (first received 11 July 2019).
NCT04073173 {published data only}
    1. NCT04073173. Stress assessment in preterm infants with respiratory distress syndrome treated or not with an analgesic drug during the traditional or the less invasive method of surfactant therapy (StrAAS). clinicaltrials.gov/ct2/show/NCT04073173 (first received 29 August 2020).
NCT04445571 {published data only}
    1. NCT04445571. Surfactant Administration by Insure or Thin Catheter (SAINT). clinicaltrials.gov/ct2/show/NCT0444557 (first received 24 June 2020).
UMIN000021785 {published data only}
    1. UMIN000021785. Effectiveness of MIST (minimally invasive surfactant therapy) under bronchoscopy in treating neonatal respiratory distress syndrome. rctportal.niph.go.jp/en/detail?trial_id=UMIN000021785 (first received 5 April 2016).

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References to other published versions of this review

Wheeler 2015
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