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Multicenter Study
. 2022 Aug 1;5(8):e2225810.
doi: 10.1001/jamanetworkopen.2022.25810.

Association of Administration of Surfactant Using Less Invasive Methods With Outcomes in Extremely Preterm Infants Less Than 27 Weeks of Gestation

Christoph Härtel  1 , Egbert Herting  2 , Alexander Humberg  2 , Kathrin Hanke  2 , Katrin Mehler  3 , Titus Keller  3 , Isabell Mauer  1 , Eric Frieauff  1 , Sascha Meyer  4 , Ulrich H Thome  5 , Christian Wieg  6 , Susanne Schmidtke  7 , Angela Kribs  3 , Wolfgang Göpel  2 ; German Neonatal Network
Collaborators, Affiliations
Multicenter Study

Association of Administration of Surfactant Using Less Invasive Methods With Outcomes in Extremely Preterm Infants Less Than 27 Weeks of Gestation

Christoph Härtel et al. JAMA Netw Open. .

Erratum in

  • Errors in a Figure.
    [No authors listed] [No authors listed] JAMA Netw Open. 2023 Apr 3;6(4):e2312619. doi: 10.1001/jamanetworkopen.2023.12619. JAMA Netw Open. 2023. PMID: 37083673 Free PMC article. No abstract available.

Abstract

Importance: The inclusion of less invasive surfactant administration (LISA) in the care of preterm infants has been found to be beneficial for respiratory outcomes. Recently, the OPTIMIST trial found higher mortality rates in the subgroup of infants born at 25 to 26 weeks' gestational age (GA) who received surfactant treatment while spontaneously breathing.

Objective: To analyze outcomes among LISA-exposed, highly vulnerable babies born at less than 27 weeks' GA within the large-scale observational cohort of the German Neonatal Network.

Design, setting, and participants: In this cohort study of data from 68 tertiary level neonatal intensive care units in Germany of infants born between 22 weeks 0 days to 26 weeks 6 days of gestation between April 1, 2009, and December 31, 2020, short-term outcomes among infants receiving LISA vs infants not receiving LISA were compared.

Exposure: Use of LISA within the first 72 hours of life.

Main outcomes and measures: The main outcomes were rates of LISA use, use of mechanical ventilation within the first 72 hours (considered failure of LISA), and association of LISA with outcomes, including death from all causes, bronchopulmonary dysplasia (BPD), death and BPD combined, pneumothorax, retinopathy of prematurity, intracerebral hemorrhage, and periventricular leukomalacia. To address potential confounding factors, multivariate logistic regression models were used.

Results: A total of 6542 infants (3030 [46.3%] female and 3512 [53.7%] male; mean [SD] GA, 25.3 (1.1) weeks; mean [SD] birth weight, 715 [180] g) were analyzed; 2534 infants (38.7%) received LISA, which was most frequently given quasi-prophylactically during delivery room management. Among the infants who received LISA, 1357 (53.6%) did not require mechanical ventilation in the first 72 hours compared with 331 infants (8.3%) of 4008 who did not receive LISA. In a multivariate logistic regression model that adjusted for GA, small-for-GA status, sex, multiple birth, inborn status, antenatal steroid use, and maximum fraction of inspired oxygen in the first 12 hours of life, LISA was associated with reduced risks of all-cause death (odds ratio [OR], 0.74; 95% CI, 0.61-0.90; P = .002), BPD (OR, 0.69; 95% CI, 0.62-0.78; P < .001), and BPD or death (OR, 0.64; 95% CI, 0.57-0.72; P < .001) compared with infants without LISA exposure.

Conclusions and relevance: The results of this long-term multicenter cohort study suggest that LISA may be associated with reduced risks of adverse outcomes in extremely preterm infants.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Härtel reported receiving grants from the Bundesministerium für Bildung und Forschung (BMBF), Chiesi, and the Deutsche Forschungs Gemeinschaft (DFG) during the conduct of the study. Dr Herting reported receiving grants, personal fees, travel support, and speaker honoraria from Chiesi during the conduct of the study; receiving support for other surfactant studies from Chiesi; receiving personal fees and speaker honoraria from Pfizer, Merck Sharp and Dohme, Sanofi, and AstraZeneca outside the submitted work; holding a patent with Chiesi for less invasive surfactant therapy; and having membership on a board of the DFG. Dr Hanke reported receiving nonfinancial support for travel from Chiesi outside the submitted work. Dr Thome reported receiving travel grants from Chiesi and Pfizer outside the submitted work. Dr Kribs reported receiving grants from the BMBF during the conduct of the study and personal fees from Chiesi outside the submitted work. Dr Göpel reported receiving grants from the BMBF during the conduct of the study and personal fees from Chiesi and Abbott outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flow Diagram
GA indicates gestational age; GNN, German Neonatal Network; LISA, less invasive surfactant administration.
Figure 2.
Figure 2.. Percentages of German Neonatal Network–Enrolled Infants Not Surviving the Primary Stay in Hospital
Values are presented as means and 95% CIs (whiskers). P values were derived using 2-sided χ2 tests. LISA indicates less invasive surfactant administration.
See this image and copyright information in PMC

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References

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