Comparative Effectiveness of Bubble versus Ventilator-Derived Nasal Continuous Positive Airway Pressure on the Management of Transient Tachypnoea of the Newborn: A Retrospective Cohort Study in a Tertiary Care Hospital

doi:10.21203/rs.3.rs-5278451/v1

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Comparative Effectiveness of Bubble versus Ventilator-Derived Nasal Continuous Positive Airway Pressure on the Management of Transient Tachypnoea of the Newborn: A Retrospective Cohort Study in a Tertiary Care Hospital

https://doi.org/10.21203/rs.3.rs-5278451/v1

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Background

Transient Tachypnoea of the Newborn (TTN) is a common cause of neonatal respiratory distress, often requiring respiratory support with Continuous Positive Airway Pressure (CPAP). This study compares the effectiveness of Bubble CPAP (BCPAP) and Ventilator-derived CPAP (VCPAP) in reducing NICU admissions in late preterm and term neonates with TTN.

Materials and Methods

This retrospective cohort study analysed 144 neonates born at or beyond 34 weeks' gestation with TTN who received either BCPAP (n = 70) or VCPAP (n = 74) in the delivery room. Outcomes included NICU admissions, length of hospital stay, intubation rates, surfactant use, and complications.

Results

There were no significant differences between the groups in NICU admissions (p > 0.05), hospital stay, intubation rates, or surfactant use. No cases of sepsis, necrotizing enterocolitis, or pneumothorax were observed.

Conclusion

Both BCPAP and VCPAP were equally effective in managing TTN, with no notable difference in clinical outcomes or safety. Further prospective studies are required to validate these findings.

Transient tachypnoea of newborn

Ventilator-derived continuous positive pressure ventilation (CPAP)

Bubble CPAP

Respiratory distress

Delivery room

Transient Tachypnoea of the Newborn (TTN) is a common respiratory condition characterized by tachypnoea and signs of respiratory distress in infants born at or after 34 weeks' gestation. Among the primary causes of respiratory distress (RD) in neonates are respiratory distress syndrome (RDS) and TTN, which together account for the majority of neonatal intensive care unit (NICU) admissions. The incidence of RD is reported to affect approximately 7% of term newborns (≥ 37 + 0 weeks' gestation) and 9% of late preterm infants (34 + 0–36 + 6 weeks' gestation) [1, 2].

Several therapeutic interventions have been proposed to facilitate the clearance of excess pulmonary fluid underlying TTN. These include diuretics, fluid restriction, salbutamol, steroids (both prenatal and postnatal), and continuous positive airway pressure (CPAP) [3–5]. Early initiation of CPAP in newborns with TTN, particularly in the delivery room, has been shown to mitigate respiratory distress, reduce NICU admissions, and shorten hospitalization duration [6–9]. Elective caesarean sections performed before 38 weeks are associated with increased TTN risk [9, 10]. In Türkiye, higher caesarean rates contribute to a greater incidence of TTN, placing significant demand on NICU resources. Effective management strategies are thus essential to reduce NICU admissions and healthcare costs [11, 12].

Various types of CPAP devices are currently utilized in the delivery room setting, including T-piece resuscitators, ventilator-derived CPAP (VCPAP), and bubble CPAP (BCPAP). Bubble CPAP was first introduced for treating RDS in newborns in the 1970s and has since become widely adopted, especially in low-income countries, due to its simplicity and lower cost compared to conventional devices [13–15]. BCPAP provides effective respiratory support using basic equipment without requiring a ventilator [15–18]. The technique utilizes an oxygen-air blender, a humidifier, and a nasal cannula, with the distal end submerged in sterile water to generate pressure [16]. Bubbling creates oscillations resembling high-frequency ventilation (HFV), potentially aiding alveolar recruitment and airway patency [19]. While BCPAP is favoured in developing countries for its cost-effectiveness [20–25], the comparative superiority of BCPAP over VCPAP remains uncertain, necessitating further research to determine the optimal CPAP method in the delivery room [26].

TTN carries significant clinical implications, including prolonged maternal-infant separation, unnecessary antibiotic exposure, and extended hospital stays [5]. The standard practice in the unit where this study was conducted involves CPAP administration for up to two hours in the delivery room, with NICU admission considered for infants who show no improvement. Both VCPAP and BCPAP are routinely used. While CPAP is well-studied in neonatal RDS, evidence comparing BCPAP and VCPAP in TTN, especially regarding NICU admissions, is limited. We hypothesize that BCPAP, through bubble-induced airway oscillation, may reduce NICU admissions. Furthermore, we aim to determine whether either method improves hospital length of stay, intubation rates, or secondary complications.

The primary objective of this study is to compare the effectiveness of BCPAP and VCPAP in the delivery room in reducing NICU admissions among neonates born at or beyond 34 weeks of gestation diagnosed with TTN. Secondary objectives include evaluating the impact of these CPAP modalities on the duration of hospitalization, need for intubation, surfactant administration, and the incidence of complications such as pneumothorax, necrotizing enterocolitis (NEC), sepsis, and mortality. To address these aims, we retrospectively analysed data from 144 cases, comprising 70 infants treated with BCPAP and 74 with VCPAP.

Aim

The primary aim of this study is to compare the effectiveness of BCPAP and VCPAP in the delivery room in reducing NICU admissions among neonates born at or beyond 34 weeks of gestation diagnosed with TTN. Secondary objectives include evaluating the impact of these CPAP modalities on the duration of hospitalization, need for intubation, surfactant administration, and the incidence of complications such as pneumothorax, necrotizing enterocolitis (NEC), sepsis, and mortality.

Design and setting of the study

Study design

Newborns with a gestational age of 34 weeks or greater, born in the delivery unit of a tertiary care hospital between April 1, 2023, and January 25, 2024, who developed respiratory distress necessitating CPAP administration within the first 30 minutes of life, were retrospectively enrolled in this study. Ethical approval for the study was obtained from the institutional ethics committee (meeting No. 118 dated June 10, 2024). VCPAP is the preferred method for late preterm and term infants with TTN. However, when a ventilator circuit is unavailable, a manually assembled BCPAP system, as depicted in Figure 1, is employed. The standard protocol at this centre involves monitoring these infants with CPAP for approximately two hours in the delivery room. Following this observation period, infants who stabilize are returned to their mothers, while those whose respiratory distress persists or worsens are admitted to the NICU. Once admitted to the NICU, all infants are managed with VCPAP, regardless of the CPAP method initially used in the delivery room.

The characteristics of participants or description of materials

Participant

A total of 144 neonates over 34 weeks of gestation who received CPAP treatment in the delivery room, 70 with BCPAP and 74 with VCPAP, were included in this study. Infants born earlier than 34 weeks’ gestational age, referred to an external centre, requiring intubation within the first hour, having congenital-metabolic or cardiac anomalies, defined as large for gestational age (LGA) due to maternal diabetes, and those with incomplete records were excluded from the study.

Data collection

Demographic data for the enrolled neonates, including gestational age, sex, mode of delivery, birth weight, 1- and 5-minute Apgar scores, antenatal steroid administration, and pH and pCO2 values from umbilical cord blood gas analyses, as well as the duration of CPAP application in the delivery room, were obtained from medical archive records.

In the delivery room, ventilator-derived CPAP is administered to infants using a paediatric ventilator (MVP-10, Bio-Med Devices, Inc., Guilford, CT, USA). A RAM cannula (Neotech Products LLC, Witherspoon Pkwy, Valencia, CA, USA) serves as the interface. CPAP is delivered at a pressure of 6 cm H₂O, with FiO₂ adjusted as needed to achieve the target oxygen saturation levels.

In the manually assembled BCPAP method, an appropriately sized nasal oxygen cannula (Nasal Oxygen Cannula Paediatric, Yılkal Med, Konya, Türkiye) is selected to fit the infant’s nostrils and connected to the oxygen-air mixer (NEO2 Blend, Bio-Med Devices, Inc., Guilford, CT, USA). The segment where the cannula splits into two is cut, and a clamp is placed on the proximal end. The cannula is inserted into the infant’s nostrils, with its distal end submerged 6–7 cm into a plastic bag filled with sterile isotonic saline. Underwater bubble CPAP is administered at a flow rate of 4–6 L/min, with FiO₂ adjusted as needed, as illustrated in Figure 1. The severity of respiratory distress in the delivery room is assessed using the Downes score. [27]. A total score of 0 indicates no distress, 1–4 suggests mild respiratory distress, 5–7 indicates moderate distress, and a score above 7 signifies severe distress or impending respiratory failure. Infants whose Downes score does not improve with CPAP and whose respiratory distress persists are admitted to the NICU within 2 hours. In the NICU, all infants continue receiving CPAP via a ventilator (Leoni Plus, Germany) with a RAM cannula serving as the interface.

The primary outcome of the study was defined as the number of infants requiring NICU admission following CPAP treatment. The secondary outcomes included the duration of hospitalization for infants admitted to the NICU, the necessity for intubation, the requirement for surfactant therapy, mortality, and the incidence of complications such as pneumothorax, sepsis, and necrotizing enterocolitis (NEC), all of which were also sourced from medical archive records.

Sample Size

A total of 144 participants were included in the study, with 70 in the BCPAP group and 74 in the VCPAP group. Based on this sample size, with an alpha level of 0.05 and statistical power set at 90%, the detectable effect size (Cohen's d) was estimated to be approximately 0.47. This indicates that the study is sufficiently powered to detect a moderate effect size between the two groups regarding NICU admission rates, ensuring reliable comparisons.

Statistical analysis

All statistical analyses were conducted using SPSS version 25.0 (IBM Corp., Armonk, NY). Categorical variables were expressed as frequencies and percentages, and differences between the two groups were evaluated using the Chi-square test or Fisher’s exact test, as appropriate. Continuous variables were presented as mean ± standard deviation (SD) for normally distributed data or median and interquartile range (IQR) for non-normally distributed data. The Shapiro-Wilk test was used to assess normality. An independent samples t-test was employed for comparing normally distributed continuous variables, while the Mann-Whitney U test was used for non-normally distributed variables. A p-value of less than 0.05 was considered statistically significant.

A total of 144 patients were enrolled in the study, with 70 in the BCPAP group and 74 in the VCPAP group. The demographic and baseline characteristics were similar between the groups as summarised in Table 1. The median gestational age (BCPAP: 37 weeks; VCPAP: 37.8 weeks; p = 0.22) and median birth weight (BCPAP: 2925 g; VCPAP: 3030 g; p = 0.83) did not differ significantly. The proportion of male infants (BCPAP: 58.5%; VCPAP: 45.9%; p = 0.13), the rate of caesarean deliveries (BCPAP: 65.7%; VCPAP: 71.6%; p = 0.44), and antenatal steroid administration (BCPAP: 7.1%; VCPAP: 6.8%; p = 0.92) were also comparable between groups. No significant differences were noted in the 1- and 5-minute Apgar’s scores or in cord blood gas analyses, with similar pH values (BCPAP: 7.30; VCPAP: 7.28; p = 0.17) and pCO2 levels (BCPAP: 41.8 mmHg; VCPAP: 43.4 mmHg; p = 0.23).

Table 1

Demographic and baseline characteristics of the groups.
Variables	BCPAP (n = 70)	VCPAP (n = 74)	p-value
Gestational age^a (wk)	37 (35.9–38.3)	37.8 (36.2–38.6)	0.22
Birth weight^a (g)	2925 (2568–3467)	3030 (2750–3327)	0.83
Male sex, n (%)	41 (58.5)	34 (45.9)	0.13
Caeserian delivery, n (%)	46 (65.7)	53 (71.6)	0.44
Antenatal steroids, n (%)	5 (7.1)	5 (6.8)	0.92
Apgar’s score (1)^a	6.5 (6–7)	6.6 (6–8)	0.26
Apgar’s score (5)^a	7.8 (8–8)	8.0 (8–9)	0.32
Cord blood pH at birth^b	7.30 ± 0.67	7.28 ± 0.68	0.17
Cord blood pCO2 at birth^a	41,8 (37,9–48,8)	43,4 (39,8–49,5)	0,23
CPAP duration time in delivery room^a (min)	60 (60–120)	60 (60–90)	0.69
BCPAP-Bubble Continuous Positive Pressure Ventilation, VCPAP-Ventilator Derived Continuous Positive Pressure Ventilation.
^aMedian (interquartile range)
^bMean ± standard deviation

Although NICU admission was more frequent in the BCPAP group (41.4%) compared to the VCPAP group (31%), this difference, considered as the primary outcome, was not statistically significant (p = 0.19). The duration of hospitalization was similar between the groups (BCPAP: 2 days; VCPAP: 2 days; p = 0.66), as were the rates of intubation (BCPAP: 6 infants; VCPAP: 4 infants; p = 0.76) and surfactant use (BCPAP: 2 infants; VCPAP: 1 infant; p = 0.69). The median CPAP duration in the delivery room was 60 minutes for both groups, with interquartile ranges of 60–120 minutes for BCPAP and 60–90 minutes for VCPAP (p = 0.69), as detailed in Table 2. There were no cases of mortality, sepsis, necrotizing enterocolitis (NEC), or pneumothorax in either group.

Table 2

Clinical characteristics of the groups.
Variables	BCPAP (n = 70)		p-value
Need for NICU admission (n, %)	29, %41.4	23, %31	0.19
Duration of hospital stay^a (day)	2 (1-3.25)	2 (2–2)	0.66
Need for intubation (n)	6	4	0.76
Need for surfactant (n)	2	1	0.69
Mortality (n)	0	0	NA
BCPAP-Bubble Continuous Positive Pressure Ventilation, NICU-Neonatal intensive care unit, VCPAP-Ventilator Derived Continuous Positive Pressure Ventilation
^aMedian (interquartile range)

This study evaluated the effectiveness of ventilator-derived CPAP (VCPAP) and manually prepared bubble CPAP (BCPAP) in the delivery room, focusing on NICU admission and other clinical outcomes in late preterm and term infants with transient tachypnoea of the newborn (TTN). The results showed no statistically significant differences between the two methods in NICU admission rates (VCPAP: 31%, BCPAP: 41.4%; p > 0.05), hospitalization duration, intubation needs, surfactant administration, or CPAP duration in the delivery room. Additionally, no cases of pneumothorax, necrotizing enterocolitis (NEC), or sepsis were reported, suggesting both methods may provide safe respiratory support in this population. However, the absence of a control group receiving standard care with supplemental oxygen limits conclusions about CPAP's direct effect on NICU admissions. Previous studies have shown that CPAP reduces oxygen requirements, shortens hospital stays, and lowers the need for respiratory support compared to free-flow oxygen, without raising the risk of pneumothorax [9, 28]. These findings emphasize the importance of CPAP in managing respiratory distress in neonates. Importance of using CPAP as early respiratory support in newborns with TTN to improve clinical outcomes.

Existing research on BCPAP and VCPAP has largely focused on preterm infants with respiratory distress syndrome (RDS) [20, 23, 29–32]. For instance, Shadkam et al. evaluated BCPAP versus VCPAP in preterm infants born between 28 and 34 weeks of gestation. Although no significant differences were found in CPAP duration, oxygen therapy, or the incidence of RDS-related complications—such as bronchopulmonary dysplasia (BPD), patent ductus arteriosus (PDA), and intraventricular haemorrhage (IVH)—the BCPAP group required significantly shorter mechanical ventilation [20]. Similarly, Tagare et al. demonstrated higher success with BCPAP, defined by reductions in respiratory distress severity, CPAP pressure, and oxygen requirements, in infants born before 37 weeks [33]. Differences in patient populations, gestational age ranges, and clinical protocols across studies may account for the discrepancies with the present findings, emphasizing the importance of context-specific research to optimize respiratory support strategies.

Device selection remains a critical consideration in CPAP therapy. In this study, VCPAP was the first-line method for late preterm and term infants in the delivery room, while a manually assembled BCPAP system was used when ventilator circuits were unavailable. Resource availability, clinician expertise, and personal preference often drive this choice in practice, rather than definitive evidence. Although BCPAP offers benefits like affordability and ease of use, it is essential to ensure the components meet quality standards to avoid unintended risks [29, 34, 35]. Baldursdottir et al. cautioned that systems with narrow nasal interfaces and small expiratory arms may increase the work of breathing, compromising both efficacy and safety. Non-standardized systems can deliver inconsistent pressure and should not be considered true BCPAP [36]. In this centre, an oxygen cannula serves as the BCPAP interface, but using a larger-diameter option, such as a Hudson nasal cannula, could enhance pressure delivery by reducing airway resistance and improving outcomes.

The success of CPAP therapy depends not only on the equipment and interface but also on the proficiency of healthcare providers [34]. Nursing staff play a crucial role, as their ability to properly apply and monitor CPAP directly influences treatment outcomes. Comprehensive training and adherence to standardized protocols are essential to maximize therapeutic effectiveness.

Although this study's retrospective design introduces certain limitations, such as potential selection bias, steps were taken to ensure reliable comparisons between the two groups. There were no significant differences between the groups in terms of gestational age, gender, mode of delivery, birth weight, antenatal steroid use, 1st and 5th-minute Apgar scores, or umbilical cord blood gas parameters (pH and pCO₂). Additionally, all infants admitted to the NICU received CPAP with the same ventilator model and RAM cannula interface, minimizing potential confounding factors and enhancing the validity of the results.

In conclusion, this study's findings suggest that both VCPAP and BCPAP are equally effective in reducing NICU admissions in the delivery room management of late preterm and term infants with TTN. Given the absence of significant differences in clinical outcomes between the two methods, both can be considered safe and effective options for use in the delivery room. However, the choice of CPAP method should be guided by resource availability, clinical context, and healthcare providers' expertise. Future prospective studies with larger sample sizes, standardized nasal interfaces, and control groups are essential to better determine the optimal CPAP strategy for infants with respiratory distress. Such studies would help clarify the relative advantages of each method and ensure the delivery of consistent, high-quality care.

BCPAP: Bubble Continuous Positive Airway Pressure

BPD: Bronchopulmonary Dysplasia

CPAP: Continuous Positive Airway Pressure

FiO₂: Fraction of Inspired Oxygen

HFV: High-Frequency Ventilation

IVH: Intraventricular Hemorrhage

LGA: Large for Gestational Age

NEC: Necrotizing Enterocolitis

NICU: Neonatal Intensive Care Unit

PDA: Patent Ductus Arteriosus

pCO₂: Partial Pressure of Carbon Dioxide

pH: Potential of Hydrogen

RDS: Respiratory Distress Syndrome

TTN: Transient Tachypnoea of the Newborn

VCPAP: Ventilator-derived Continuous Positive Airway Pressure

Ethical Approval

Ethical approval for this study was obtained from the Ethics Committee of Prof. Dr. Cemil Taşcıoğlu City Hospital. Meeting No. 118, dated June 10, 2024

Consent for Publication

Not applicable

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request.

Competing of Interest

The author has disclosed no conflicts of interest.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors

Authors’ Contributions

ET Constructed the study, collected and analysed the data, and wrote the manuscript. ZTÇ Managed patient care and ensured the standardized application of CPAP in both groups. All the authors have read and approved the final manuscript

Acknowledgments:

The author wishes to thank to Prof. Adnan İşgör for illustrating the manual BCPAP system used in this study. Special thanks to Clinical Pharmacist Yunus Emre Ayhan for his valuable support in manuscript preparation. The author also acknowledges the contributions of the NICU nursing team, whose meticulous care and application of CPAP protocols were crucial to the success of this study. Finally, the authors are grateful to the hospital administration for granting access to archived patient data.

Clinical trial number: not applicable.

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No competing interests reported.

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Comparative Effectiveness of Bubble versus Ventilator-Derived Nasal Continuous Positive Airway Pressure on the Management of Transient Tachypnoea of the Newborn: A Retrospective Cohort Study in a Tertiary Care Hospital

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