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• Nebulised Surfactant Therapy : Needs Rigorous pragmatic Trial before Implementation
  Jogender Kumar, Bharti Yadav
  Published on: 12 October 2018

• Published on: 12 October 2018

  Nebulised Surfactant Therapy : Needs Rigorous pragmatic Trial before Implementation

  • Jogender Kumar, Neonatologist AIIMS Jodhpur (Raj.)
  • Other Contributors:
    • Bharti Yadav, Neonatologist

  We read with great interest the article by Minocchieri et al., published in this journal and found it very interesting and relevant to the current context.1 However, we have certain observations about the conduct of the study which question its external validity.
  The authors used supplemental fractional inspired oxygen (FiO2) of 0.22–0.30 as enrollment criteria for administering surfactant. As per current standard, most of the neonatologist will not agree to give surfactant at such a low FiO2 requirement in the first 4 hours. It might be possible that many enrolled babies could have been easily managed without surfactant and it was an unnecessary intervention for them. This is further supported by the fact that in current study 28% of babies were weaned to room air in the first 4 hours, hence could not be enrolled. Also, the author's suggestion of enrolling babies requiring Fio2 > 25 % seems to be very liberal. Most of the units administer surfactant beyond 30% supplemental oxygen requirement.
  The total duration of invasive as well as any mechanical ventilation was higher in the intervention group, suggesting that the harms may outweigh the benefits.
  Although the authors showed that the intervention had its intended effect in babies born at >32 weeks’ gestation, in the current era, where universal antenatal steroid coverage is available, these babies hardly need surfactant. In this trial, a significant number of babies > 32 weeks received su...

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  We read with great interest the article by Minocchieri et al., published in this journal and found it very interesting and relevant to the current context.1 However, we have certain observations about the conduct of the study which question its external validity.
  The authors used supplemental fractional inspired oxygen (FiO2) of 0.22–0.30 as enrollment criteria for administering surfactant. As per current standard, most of the neonatologist will not agree to give surfactant at such a low FiO2 requirement in the first 4 hours. It might be possible that many enrolled babies could have been easily managed without surfactant and it was an unnecessary intervention for them. This is further supported by the fact that in current study 28% of babies were weaned to room air in the first 4 hours, hence could not be enrolled. Also, the author's suggestion of enrolling babies requiring Fio2 > 25 % seems to be very liberal. Most of the units administer surfactant beyond 30% supplemental oxygen requirement.
  The total duration of invasive as well as any mechanical ventilation was higher in the intervention group, suggesting that the harms may outweigh the benefits.
  Although the authors showed that the intervention had its intended effect in babies born at >32 weeks’ gestation, in the current era, where universal antenatal steroid coverage is available, these babies hardly need surfactant. In this trial, a significant number of babies > 32 weeks received surfactant and invasive ventilation, the reason for which is unclear.
  Authors used FiO2 alone as a criterion for defining CPAP failure and positive end-expiratory pressure (PEEP) level was not considered. In such cases, many babies who can be managed by increasing PEEP may have got intubated even without adequate recruitment leading to increased intubation rates. This may explain the increased CPAP failure rates in the study population as compared to the historical cohort. On careful analysis of CPAP failure cases, the mean PEEP pressure was 6 cm only, which supports the above hypothesis.
  Although, the trial intended to see the effect on intubation and mechanical ventilation, both of which have a direct effect on bronchopulmonary dysplasia (BPD) rates, the better primary outcome would have been the incidence of BPD.
  Surprisingly the cesarean delivery rates very high in the study population.
  Competing interests: None
  Source of funding: None

  References:

  1. Minocchieri S, Berry CA, Pillow JJ. Nebulised surfactant to reduce severity of respiratory distress: a blinded, parallel, randomised controlled trial. Archives of Disease in Childhood - Fetal and Neonatal Edition. Published Online First: 26 July 2018. doi:10.1136/archdischild-2018-315051

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  Conflict of Interest:
  None declared.

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