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Open Access 01-12-2021 | Patent Ductus Arteriosus | Research article

Non-invasive duo positive airway pressure ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: a randomized controlled trial

Authors: Arash Malakian, Mohammad Reza Aramesh, Mina Agahin, Masoud Dehdashtian

Published in: BMC Pediatrics | Issue 1/2021

Abstract

Background

The most common cause of respiratory failure in premature infants is respiratory distress syndrome. Historically, respiratory distress syndrome has been treated by intratracheal surfactant injection followed by mechanical ventilation. In view of the risk of pulmonary injury associated with mechanical ventilation and subsequent chronic pulmonary lung disease, less invasive treatment modalities have been suggested to reduce pulmonary complications.

Methods

148 neonates (with gestational age of 28 to 34 weeks) with respiratory distress syndrome admitted to Imam Khomeini Hospital in Ahwaz in 2018 were enrolled in this clinical trial study. 74 neonates were assigned to duo positive airway pressure (NDUOPAP) group and 74 neonates to nasal continuous positive airway pressure (NCPAP) group. The primary outcome in this study was failure of N-DUOPAP and NCPAP treatments within the first 72 h after birth and secondary outcomes included treatment complications.

Results

there was not significant difference between DUOPAP (4.1 %) and NCPAP (8.1 %) in treatment failure at the first 72 h of birth (p = 0.494), but non-invasive ventilation time was less in the DUOPAP group (p = 0.004). There were not significant differences in the frequency of patent ductus arteriosus (PDA), pneumothorax, intraventricular hemorrhage (IVH) and bronchopulmonary dysplasia (BPD), apnea and mortality between the two groups. Need for repeated doses of surfactant (p = 0.042) in the NDUOPAP group was significantly lower than that of the NCPAP group. The duration of oxygen therapy in the NDUOPAP group was significantly lower than that of the NCPAP group (p = 0.034). Also, the duration of hospitalization in the NDUOPAP group was shorter than that of the NCPAP group (p = 0.002).

Conclusions

In the present study, DUOPAP compared to NCPAP did not reduce the need for mechanical ventilation during the first 72 h of birth, but the duration of non-invasive ventilation and oxygen demand, the need for multiple doses of surfactant and length of stay in the DUOPAP group were less than those in the CPAP group.

Trial registration

IRCT20180821040847N1, Approved on 2018-09-10.

Gnanaratnem J, Finer N. Neonatal acute repiratory failure. Curr opin pedicutr. 2000 Jun;12(13):227 – 32. https://doi.org/10.1097/00008480-200006000-00009.

Moya FR, Mazela J, Shore PM, et al. Prospective observational study of early respiratory management in preterm neonates less than 35 weeks of gestation. BMC Pediatr. 2019;19:147. https://doi.org/10.1186/s12887-019-1518-3

Bhandari V. The potential of non-invasive ventilation to decrease BPD. Semin Perinatol. 2013;37:108–14. https://doi.org/10.1053/j.semperi.2013.01.007.CrossRefPubMed

Blennow M, Bohlink K. Surfactant and noninvasive ventilation. neonatology. 2015;107(4):330. https://doi.org/10.1159/000381122. Epub 2015 Jun 5.CrossRefPubMed

Reiterer F, Polin RA. Non –invasive ventilation in Preterm infants: a clinical Review. Int J Pediatr Neonat Care. 2016;2:118.CrossRef

Schmölzer GM, Kumar M, Pichler G, Aziz K, O’Reilly M, Cheung PY. Non-invasive versus invasive respiratory support in preterm infants at birth: systematic review and meta-analysis. Bmj. 2013;347:1–8. https://doi.org/10.1136/bmj.f5980.CrossRef

Fischer HS, Buehrer C. Avoiding endotracheal ventilation to prevent bronchopulmonary dysplasia: a meta-analysis. Pediatrics. 2013;132(5):1351–60. https://doi.org/10.1542/peds.2013-1880.CrossRef

Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR and al, e., Early CPAP versus surfactant in extremely preterm infants. New England J Med, 2010;362(21):1970–1979.https://doi.org/10.1056/NEJMoa0911783.

Göpel W, Kribs A, Ziegler A, Laux R, Hoehn T, Wieg C, Groneck P. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet. 2011;378(9803):1627–34. https://doi.org/10.1016/S0140-6736(11)60986-0.CrossRefPubMed

10.

Carlo WA. Should nasal high-frequency ventilation be used in preterm infants? Acta Paediatr. 2008;97(11):1484–5. https://doi.org/10.1111/j.1651-2227.2008.01016.x.CrossRefPubMed

11.

Sadeghnia A, Barekateyn B, Badiei Z, Hosseini SM. Analysis and comparison of the effects of N-BiPAP and Bubble-CPAP in treatment of preterm newborns with the weight of below 1500 grams affiliated with respiratory distress syndrome: a randomised clinical trial. Adv Biomed Res. 2016. https://doi.org/10.4103/2277-917174965.CrossRefPubMedPubMedCentral

12.

Zhou B, Zhai JF, Jiang HX, Liu Y, Jin B, Zhang YY, Wu JB. Usefulness of DuoPAP in the treatment of very low birth weight preterm infants with neonatal respiratory distress syndrome. Eur Rev Med Pharmacol Sci. 2015;19(4):573–7.PubMed

13.

Bahman-Bijari B, Malekiyan A, Niknafs P, Baneshi MR. Bubble-CPAP vs. Ventilatory-CPAP in preterm infants with respiratory distress. Iran J Pediatr. 2011 Jun;21(2):151–8. PMID: 23056781; PMCID: PMC3446163.

14.

Wiswel TH, Srinivasan P, Continues positive air way perssure. In:Gold Smith JP, Karotkin EH(eds). Assisted ventilation of the Neonate. 3rd ed. Philadelphia: Sunders, 2003;127–143.

15.

Dai MY, Zheng GF, Hao XQ, Liu S, Wu R. Silverman Anderson score applying in preterm infants with respiratory distress syndrome. Chin J Child Health Care, 2013;7. https://en.cnki.com.cn/Article_en/CJFDTotal-ERTO201307027.htm.

16.

Malakian A, Bashirnezhadkhabaz S, Aramesh MR, Dehdashtian M. Noninvasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 Aug;33(15):2601–7. doi: 10.1080/14767058.2018.1555810. Epub 2019 Mar 8. PMID: 30513030.

17.

Stevens TP, Blennow M, Myers EH, Soll R. Early surfactant administration with brief ventilation vs. selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome. Cochrane Database Syst Rev. 2007;4:CD003063. https://doi.org/10.1002/14651858CD003063pub3.CrossRef

18.

Kong LK, Kong XY, Li LH, Dong JY, Shang MX, Chi JH, Huang RX, Zheng Y, Ma JE, Chen XC, Wang Y, Cai N, Feng ZC. Comparative study on application of Duo positive airway pressure and continuous positive airway pressure in preterm neonates with respiratory distress syndrome. Zhongguo dang dai er ke za zhi = Chin J Contemp Pediatr. 2012;14(12):888–92.

19.

Lista G, Castoldi F, Fontana P, Daniele I, Cavigioli F, Rossi S, Diego Mancuso D, Reali R. Nasal continuous positive airway pressure (CPAP) versus bi-level nasal CPAP in preterm babies with respiratory distress syndrome: a randomised control trial. Arch Dis Childhood-Fetal Neonatal Edition. 2010;95(2):85–9. https://doi.org/10.1136/adc.2009.169219.CrossRef

20.

Mrinal S, MariJ-sankar P, et al. Preterm VLBW Neonates with early onset respiratory distress. J Trop Pediatr. 2011;57:274–9.CrossRef

21.

Kamper J, Wulff K, Larsen C, Lindequist S. Early treatment with nasal continuous positive airway pressure in very low-birth‐weight infants. Acta Paediatr. 1993;82(2):193–7. https://doi.org/10.1111/j.1651-2227.1993.tb12637.x.CrossRefPubMed

22.

Mazzella M, Bellini C, Calevo MG, Campone F, Massocco D, Mezzano P, Zullinoa E, Scopesia F, Arionia C, Bonaccia W, Serra G. A randomised control study comparing the infant flow driver with nasal continuous positive airway pressure in preterm infants. Arch Dis Childhood-Fetal Neonatal Edition. 2001;85(2):86–90. https://doi.org/10.1136/fn.85.2.F86.CrossRef

23.

Thomson MA. Continuous positive airway pressure and surfactant; combined data from animal experiments and clinical trials. Neonatology. 2002;81(Suppl. 1):16–9. https://doi.org/10.1159/000056766.CrossRef

24.

Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB. Nasal Cpap or intubation at birth for very preterm infants. N Engl J Med. 2008;358(7):700–8.CrossRef

25.

Di Fiore JM, Walsh M, Wrage L, Rich W, Finer N, Carlo WA, Martin RJ, SUPPORT Study Group of Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Low oxygen saturation target range is associated with increased incidence of intermittent hypoxemia. J Pediatr. 2012;161(6):1047–52.CrossRef

26.

Thomson MA. Early nasal continuous positive airways pressure (nCPAP) with prophylactic surfactant for neonates at risk of RDS. The IFDAS multi-centre randomised trial. In Pediatric Research 2002 (Vol. 51, No. 4, pp. 379A-379A). Baltimore: Int Pediatric Research Foundation, Inc.

27.

Dargaville PA, Gerber A, Johansson S, De Paoli AG, Kamlin COF, Orsini F, Davis PG. Incidence and outcome of CPAP failure in preterm infants. Pediatrics. 2016;138(1):1–12. https://doi.org/10.1542/peds.2015-3985.CrossRef

28.

Gonçalves-Ferri WA, Martinez FE. Nasal Cpap in the delivery room for new born with extremely low birth weight in a hospital in a developing country. Braz J Med Biol Res. 2013;46(10):892–6 -431 X2013 2849.CrossRef

29.

Gao X, Yang B, Hei M, Cui X, Wang J, Zhou G, Qu S. [Application of three kinds of non-invasive positive pressure ventilation as a primary mode of ventilation in premature infants with respiratory distress syndrome: a randomized controlled trial]. Zhonghua Er Ke Za Zhi. 2014;52(1):34–40 Chinese. PMID: 24680406.PubMed

30.

Aguiar T, Macedo I, Voutsen O, Silva P, Nona J, Araujo C. Nasal bilevel versus continuous positive airway pressure in preterm infants: a randomized controlled trial. J Clin Trials. 2015;5(221):2167 – 0870. https://doi.org/10.4172/2167-0870.1000221.CrossRef

31.

Victor S, Roberts SA, Mitchell S, Aziz H, Lavender T; Extubate Trial Group. Biphasic positive airway pressure or continuous positive airway pressure: a randomized trial. Pediatrics. 2016;138(2):e20154095. https://doi.org/10.1542/peds.2015-4095.

32.

Arora V, Gediya SG, Balai SS. Nasal CPAP vs Bi-level Nasal CPAP in preterms with RDS: a randomized control study. Int J Contemp Pediatr. 2017;4(3):975–8. https://doi.org/10.18203/2349-3291.ijcp20171710.CrossRef

33.

Donn SM, Manual of neonatal respiratory care. S. K. Sinha, editor. Berlin Heidelberg New York:Springer., 2012;93–98.

34.

Ricotti A, Salvo V, Zimmermann LJ, Gavilanes AW, Barberi I, Lista G, Colivicchi M, Temporini F, Gazzolo D. N-SIPPV versus bi-level N-CPAP for early treatment of respiratory distress syndrome in preterm infants. J Matern-Fetal Neonatal Med. 2013;26(13):1346–51. https://doi.org/10.3109/14767058.2013.784255.CrossRefPubMed

35.

Salvo V, Lista G, Lupo E, Ricotti A, Zimmermann LJI, Gavilanes AWD, Gitto E, Colivicchi M, Ferraù V, Gazzolo D. Comparison of three non-invasive ventilation strategies (NSIPPV/BiPAP/NCPAP) for RDS in VLBW infants. J Matern-Fetal Neonatal Med. 2018;31(21):2832–8. https://doi.org/10.1080/14767058.2017.1357693.CrossRefPubMed

36.

Rong ZH, Li WB, Liu W, Cai BH, Wang J, Yang M, Wei L, Chang LW. Nasal bi-level positive airway pressure (BiPAP) versus nasal continuous positive airway pressure (CPAP) in preterm infants ≤ 32 weeks: a retrospective cohort study. J Paediatr Child Health. 2016;52(5):493–8. https://doi.org/10.1111/jpc.13175.CrossRefPubMed

37.

Pillekamp F, Hermann C, Keller T, Von Gontard A, Kribs A, Roth B. Factors influencing apnea and bradycardia of prematurity–implications for neurodevelopment. Neonatology. 2007;91(3):155–61. https://doi.org/10.1159/000097446.CrossRefPubMed

Title: Non-invasive duo positive airway pressure ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: a randomized controlled trial
Authors: Arash Malakian
Mohammad Reza Aramesh
Mina Agahin
Masoud Dehdashtian
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Patent Ductus Arteriosus
Patent Ductus Arteriosus
Patent Ductus Arteriosus
Patent Ductus Arteriosus
Non-Invasive Ventilation
Published in: BMC Pediatrics / Issue 1/2021
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-021-02741-w

At a glance: The STEP trials

Springer Medicine

Non-invasive duo positive airway pressure ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: a randomized controlled trial

Abstract

Background

Methods

Results

Conclusions

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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