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ORIGINAL ARTICLE
Year : 2019  |  Volume : 8  |  Issue : 3  |  Page : 147-150

A comparative study of outcomes of nasal prongs and nasal mask as CPAP interface in preterm neonates: A randomized control trial


Department of Paediatrics, Subharti Medical College, Meerut, Uttar Pradesh, India

Date of Web Publication6-Aug-2019

Correspondence Address:
Dr. Archana Dubey
Department of Paediatrics, Subharti Medical College, Meerut, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcn.JCN_8_19

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  Abstract 


Background: Nasal prongs are a common method of providing CPAP to newborn babies. They are the cause of mild to severe trauma to the nose and nasal septum and may result in CPAP failure. Nasal masks are now being used to try and mitigate the trauma.These are form fitting masks placed over the nose and are thought to cause less trauma than nasal prongs. Methods: A study was conducted on preterm neonates (28–34-week gestation) with respiratory distress within 24 h of life, admitted in a tertiary care center, Meerut. Babies were randomized and divided into two groups while being put on bubble continuous positive airway pressure (CPAP), using either nasal prongs (Group A) or nasal masks (Group B). The data generated were collected and analyzed for mean duration of CPAP, duration of hospital stay, CPAP failure, retinopathy of prematurity, necrotizing enterocolitis, patent ductus arteriosus, and nasal trauma among both groups. Results: Eighty neonates were analyzed in the study, of which the mean duration of CPAP was 4.53 days in Group A and 5.20 days in Group B; the mean duration of hospital stay was 21.36 days in Group A and 24.58 days in Group B; CPAP failure was observed in 21.95% cases in Group A and 23.07% cases in Group B; and nasal trauma was seen in 46.34% cases in Group A and 43.58% in Group B. Statistical analysis showed no significant difference among both groups. Conclusion: The outcomes of nasal mask as interface are as effective as nasal prongs in preterm infants on CPAP therapy.

Keywords: Continuous positive airway pressure, nasal mask, nasal prongs, nasal trauma


How to cite this article:
Prakash S, Dubey A, Malik S. A comparative study of outcomes of nasal prongs and nasal mask as CPAP interface in preterm neonates: A randomized control trial. J Clin Neonatol 2019;8:147-50

How to cite this URL:
Prakash S, Dubey A, Malik S. A comparative study of outcomes of nasal prongs and nasal mask as CPAP interface in preterm neonates: A randomized control trial. J Clin Neonatol [serial online] 2019 [cited 2019 Nov 15];8:147-50. Available from: http://www.jcnonweb.com/text.asp?2019/8/3/147/264043




  Introduction Top


Respiratory distress in preterm infants is one of the most common causes of neonatal intensive care unit admissions (30%–40%).[1] Bubble continuous positive airway pressure (CPAP) is a simple, low-cost, and noninvasive method of ventilating these sick babies.[2] CPAP is a well-established mode of respiratory support in preterm infants. Early use of CPAP for stabilization of at-risk preterm infants reduces ventilator needs. Nasal prongs and nasal masks are being frequently used as interface between patient and CPAP device, especially in resource-limited settings. Nasal prongs and nasal masks both are associated with mild-to-severe nasal trauma in patients. This study was conducted to compare the outcome of nasal prong and nasal mask interfaces in preterm infants on CPAP support due to respiratory distress.


  Methods Top


A randomized controlled trial was performed between October 2016 and February 2018 in a tertiary care center. Preterm infants of gestational age 28–34 weeks with moderate respiratory distress (according to Silverman score) admitted within 6 h of life, requiring CPAP, were enrolled in the study after getting informed written consent. Babies with 5-min Apgar scores <5, major congenital malformation/anomalies, and severe sepsis/meningitis/metabolic disorders were excluded from the study. The study protocol was approved by the Ethics Committee of the institute. The sample size calculated was 93 [Figure 1].
Figure 1: The figure shows the flowchart of the study. One hundred and thirty-eight candidates were assessed for eligibility, of which 25 were excluded and 113 candidates were randomized. In nasal prong (Group A) group, 57 candidates were taken and 56 in nasal mask (Group B) group. A total of 41 candidates in Group A and 39 in Group B were selected after excluding those who had continuous positive airway pressure failure and who could not complete the study

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where

(n = sample size, σ2 = (standard deviation)2 or Variance, E = Least permissible error).

After initial stabilization, the treatment plan was delineated. Babies requiring bubble CPAP support were randomized using Tippett's random number table to one of the two groups according to the interface used to provide CPAP (Group A: binasal prongs and Group B: nasal masks). Scoring for severity of respiratory distress in preterm infants was done using the Silverman–Anderson score.[3] Outcomes were measured in different parameters. Nasal trauma was assessed when the interface was transiently removed for suctioning or cleaning.

Data were collected on structured per forma and managed using MS Excel software. Statistical analysis was performed using one-way ANOVA F-test at 1% level of significance. Statistical significance was considered if P < 0.01. The quantitative data were expressed in mean ± standard deviation (SD), and qualitative data were expressed in terms of frequency distribution.


  Results Top


A total of 138 preterm infants were assessed for eligibility to the study of which 25 newborns were excluded from the study as they did not meet the inclusion criteria. A total of 113 babies were enrolled in the study, of which 25 babies were ventilated due to CPAP failure and 8 babies left against medical advice before the study could be completed and hence were excluded [Figure 1]. Finally, 80 participants completed the study. Forty-one participants were enrolled in Group A (nasal prongs) and 39 in Group B (nasal masks). The baseline characteristics of both groups were comparable to each other [Table 1].
Table 1: Comparison of general characteristics of study participants

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The mean duration of CPAP administration in Group A (nasal prongs) was 4.536 ± 0.86 days and in Group B (nasal masks) was 5.205 ± 0.614 days (P = 0.0778). Babies in Group A had an average hospital stay of 21.36 ± 5.14 days, and babies in Group B had hospital stay of 24.58 ± 7.31 days (P = 0.7900). CPAP failure was seen in 9 (21.95%) babies in Group A and 9 (23.07%) babies in Group B (P = 0.7395). About 9.75% (4) babies in Group A and 10.25% (4) babies in Group B developed retinopathy of prematurity (ROP) (P = 0.1384). Four (9.75%) babies in Group A and 4 (10.25%) babies in Group B developed necrotizing enterocolitis (NEC) during CPAP therapy (P = 0.1384). The development of patent ductus arteriosus (PDA) was observed in 3 (07.31%) babies in Group A and 2 (07.69%) babies in Group B (P = 0.1248). Nasal trauma was observed in 48.78% (20) babies in Group A and 43.58% (17) babies in Group B during CPAP therapy (P = 0.537) [Table 2].
Table 2: Comparison of outcomes during continuous positive airway pressure therapy

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  Discussion Top


Based on our study, we observed that there is no significant difference in efficacy of binasal prongs and nasal masks in terms of mean duration of hospital stay, mean duration of CPAP therapy, CPAP failure, overall incidence of nasal trauma, development of PDA, NEC, and ROP in premature neonates.

Studies by Kieran et al.,[4] Singh et al.,[5] concluded that the overall rate of trauma, in the nasal prong group, was comparatively more than in the nasal mask group but was not statistically significant. Our study also supports the same fact.

Our study also supports Chandrasekaran et al.[6] who found severe nasal trauma to be more common (31% vs. 0%) among neonates in the nasal prong group.

Kumar et al.[7] found that local nasal complications were detected in 33.3% in nasal prong group and 20% in nasal mask group (P = 0.136).

A similar study done by Singh et al.[5] in Rainbow children and perinatal care center at Hyderabad found no significant difference in the development of PDA, ROP, and NEC in both groups.


  Conclusion Top


Based on our study, we concluded that the use of binasal prongs and nasal masks as interface during CPAP therapy makes no difference in overall outcome of nasal trauma in the patient. Both were found equally effective and comparable to each other.

Limitation

The results of our study were inconclusive, which may be due to a small sample size.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Mathai SS, Raju U, Kanitkar M. Management of respiratory distress in the newborn. Med J Armed Forces India 2007;63:269-72.  Back to cited text no. 1
    
2.
Polin RA, Sahni R. Newer experience with CPAP. Semin Neonatol 2002;7:379-89.  Back to cited text no. 2
    
3.
Silverman WA, Andersen DH. A controlled clinical trial of effects of water mist on obstructive respiratory signs, death rate and necropsy findings among premature infants. Pediatrics 1956;17:1-10.  Back to cited text no. 3
    
4.
Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants. Pediatrics 2012;130:e1170-6.  Back to cited text no. 4
    
5.
Singh J, Bhardwar V, Chirla D. To compare the efficacy and complication of nasal prongs & nasal mask CPAP in neonates. UMDS 2017;6:1392-7.  Back to cited text no. 5
    
6.
Chandrasekaran A, Sachdeva A, Sankar MJ, Agarwal R, Deorari AK, Paul VK. Nasal mask versus nasal prongs in the delivery of continuous positive airway pressure in preterm infants - An open label randomized controlled trial. E-PAS 2014:2936:512  Back to cited text no. 6
    
7.
Kumar G, Tiwari A, Shukla A, Chopra M. Study effectiveness of nasal prong and nasal mask in NCPAP in preterm neonates with respiratory distress. JMSCR 2017;5:21409-15.  Back to cited text no. 7
    


    Figures

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    Tables

  [Table 1], [Table 2]



 

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