BackgroundWith increasing use of nCPAP, the safety and comfort associated with nCPAP have come into the forefront. The reported incidence of nasal injuries associated with the use of nCPAP is 20% to 60%. A recent meta-analysis concluded that the use of nasal masks significantly decreases CPAP failure and the incidence of moderate to severe nasal injury and stress the need for a well powered RCT to confirm their findings.MethodsIn this Open label, 3 arms, sequential, stratified randomized controlled trial, we evaluated the incidence and severity of nasal injury at removal of nCPAP when using two different nasal interfaces and in three groups (i.e. rotation group, mask continue group, prong continue group). Preterm infants with gestation ≤ 30 weeks and respiratory distress within the first 6 hours of birth and in need of CPAP were eligible for the study.ResultsAmong the 175 newborns included in the study, incidence of nasal injury in mask continue group [n = 19/57 (33.3%)] was significantly less as compared to prong continue group [n = 55/60 (91.6%)] and rotation group [33/ 58 (56.9%), p value <0.0001]. Median maximum nasal injury score was significantly less in Mask continue group as compared to Prong continue group and Rotation group [Injury Score 0 (IQR 0–1) vs. Injury Score 3 (IQR 2–5) vs. Injury Score 1 (IQR 0–2), p value = <0.0001] respectively. The proportion of infants failing nCPAP was similar across the three groups.ConclusionnCPAP with nasal masks significantly reduces nasal injury in comparison with nasal prongs or rotation of nasal prongs and nasal masks. However, the type of interface did not affect the nCPAP failure rates.

Objective To test the hypothesis that oral paracetamol is non-inferior to oral ibuprofen in closing hemodynamically significant patent ductus arteriosus (hsPDA) with an a priori noninferiority (NI) margin of 15%. Study design Multicenter, randomized, controlled, NI trial conducted in level III neonatal intensive care units. Consecutively inborn preterm neonates of <32 weeks of gestation with hsPDA were included. Those with structural heart disease, major malformations, and contraindications for enteral feeding or for administration of study drugs were excluded. Interventions included oral paracetamol in the experimental arm and oral ibuprofen in the active control arm. The primary outcome was closure of hsPDA by 24 hours from the last dose of the study drug. Secondary outcome measures included closure of hsPDA by 24 hours after the first course of the study drug, rate of reopening after the first course, and adverse events associated with the study drug. Results Out of 1250 neonates screened, 161 were randomized. Oral paracetamol was noninferior to oral ibuprofen in closure of hsPDA by both per protocol analysis (62 [95.4%] vs 63 [94%]; relative risk [RR], 1.01 [95% CI, 0.94-1.1]; risk difference [RD], 1.4 [95% CI, À6 to 9]; P = .37) and intention-to-treat analysis (63 [89%] vs 65 [89%]; RR, 0.99 [95% CI, 0.89-1.12]; RD, À0.3 [95% CI, À11 to 10]; P = .47). All adverse events were comparable in the 2 study arms. Conclusions Oral paracetamol is noninferior to oral ibuprofen for the closure of hsPDA in preterm neonates of <32 weeks of gestation. No difference was observed in the adverse events studied.

IMPORTANCE Nasal continuous positive airway pressure (NCPAP) as a primary respiratory therapy in meconium aspiration syndrome (MAS) has not been studied extensively. Nasal continuous positive airway pressure, when applied in newborns with MAS, may resolve atelectasis by sufficiently expanding partially obstructed small airways and stabilizing the collapsing terminal airways to enhance oxygen exchange. OBJECTIVE To compare NCPAP vs standard care in neonates with moderate to severe respiratory failure due to MAS in reducing the need for invasive ventilation. DESIGN, SETTINGS, AND PARTICIPANTSThis multicenter open-label, parallel-group (1:1 ratio) randomized clinical trial was conducted from August 5, 2014, to May 26, 2016. Data were collected from 3 tertiary care neonatal intensive care units. All infants admitted with respiratory distress, defined as Downe score greater than 4 and peripheral capillary oxygen saturation less than 90%, were assessed for study eligibility if the chest radiograph was suggestive of MAS and they met the other inclusion criteria: gestation longer than 35 weeks, a birth weight greater than 2000 g, and born through meconium-stained amniotic fluid.INTERVENTIONS Infants were randomly assigned to either NCPAP or standard care (5-10 L/min hood oxygen). MAIN OUTCOMES AND MEASURESThe primary outcome was the need for mechanical ventilation in the first 7 days of life.RESULTS After excluding 14 infants, 67 infants were randomized to bubble NCPAP and 68 infants to standard care. Baseline characteristics were similar between the 2 groups. Infants randomized to the bubble NCPAP group needed mechanical ventilation less frequently in the first 7 days of life compared with standard care (2 [3.0%] vs 17 [25.0%]); odds ratio, 0.09; 95% CI, 0.02-0.43; P = .002). The need for surfactant (3 [4.5%] vs 11 [16.2%]; odds ratio, 0.24; 95% CI, 0.05-0.87) and culture-positive sepsis (4 [6.0%] vs 13 [19.0%]; odds ratio, 0.28; 95% CI, 0.09-0.93) were higher in the standard care group. There was an increased duration of oxygen therapy (median [interquartile range], 45.5 [28.0-78.3] vs 26 [20.0-48.0] hours; P = .001) in the standard care group. In the NCPAP group vs standard care group, incidence of persistent pulmonary hypertension (9 [13%] vs 19 [28%]; odds ratio, 0.42; 95% CI, 0.17-1.01) and duration of hospital stay (median [interquartile range], 5.0 [4.0-8.8] vs 4.0 [4.0-6.0] days; P = .14) were similar.CONCLUSIONS AND RELEVANCE Bubble NCPAP in comparison with standard care for infants with MAS reduces the need for mechanical ventilation in the first 7 days of life.

Objective To compare the level of continuous positive airway pressure (CPAP) delivered by three different CPAP delivery interfaces (RAM cannula system, Hudson prongs, and nasal mask) in preterm neonates with respiratory distress. Methods Preterm neonates with gestation between 28 weeks and 34 weeks and birth weight more than or equal to 1000 g and requiring nasal CPAP for respiratory distress were eligible for the study. During the study period, consecutive infants requiring CPAP were started on Hudson prongs or RAM cannula or nasal mask in that order. We measured the mean oropharyngeal pressure, which approximates the applied CPAP level. Oropharyngeal pressures in the recruited neonates were measured between 24 and 48 hours of postnatal age, when stable and in sleep or quiet awake state. Comparison of the delivered oropharyngeal pressures when on three different nasal interfaces at the same set flow rate and at set CPAP of 5 cm or 6 cm of H2O was the primary outcome. Results Data was analyzed from 30 neonates in each group. We found that measured oropharyngeal pressures were less than set CPAP level in all three studied interfaces. Maximum drop in oropharyngeal pressure was observed with use of RAM cannula with measured oropharyngeal pressures being 1.1 and 1.2 cm H2O less than set CPAP of 5 and 6 cm H2O respectively. Pharyngeal pressure best correlated to set CPAP level with the use of nasal mask. Conclusion None of the nasal interfaces delivered oropharyngeal pressure equivalent to the set CPAP. However, nasal mask delivered oropharyngeal pressure best matched to the set CPAP.

Introduction of n-CPAP services in a non-tertiary care neonatal unit, significantly reduced the need for up-transfers, especially in VLBW and preterm infants.