Safety and Efficacy of 2.5 mg and 1.25 mg Nebulized Salbutamol Compared with Placebo on Transient Tachypnea of the Newborns: A Triple-Blind Phase II/III Parallel Randomized Controlled Trial.

Background: To evaluate the safety and efficacy of 2.5 and 1.25 mg nebulized salbutamol on Transient Tachypnea of the Newborn (TTN) compared with placebo. Methods: We conducted a triple-blind, phase II/III parallel randomized controlled trial in two university-affiliated hospitals with neonatal intensive care units. Newborns with a confirmed diagnosis of TTN, with gestational age >35 weeks and gestational weight >2 kg were included. Cases of asphyxia, meconium aspiration syndrome, and persistent pulmonary hypertension were excluded. Ninety eligible patients were randomly allocated in three intervention groups (2.5 mg salbutamol, 1.25 mg salbutamol, and placebo), and a single-dose nebulized product was prescribed 6 hours after the birth. Safety outcomes included postintervention tachycardia, hyperglycemia, hypokalemia, and changes in blood pressure. To evaluate the efficacy, the duration of postintervention tachypnea, TTN clinical score, and clinical and paraclinical respiratory indices were assessed. Parents, Outcome assessors, and data analyzer were blind to the intervention. Results: There was no adverse reaction, including tachycardia, hypokalemia, and jitteriness. Both groups of salbutamol recipients showed significant improvement regarding respiratory rate, TTN clinical score, and oxygenation indices compared with the placebo (p-values <0.001). Nonstatistically significant higher hospital stay was observed in the placebo group. Single 2.5 mg salbutamol nebulization showed a little better outcome than the dose of 1.25 mg, although we could not find statistical superiority. Conclusion: The newly applied single high dose of 2.5 mg nebulized salbutamol is safe in treating TTN and leads to notable faster improvement of respiratory status without any considerable adverse reaction. Registry code: IRCT20190328043133N1.

Comparing Auditory Brain Stem Responses and Transient Otoacoustic Emissions in Premature Infants with Auditory Developmental Delay: Evidence of Temporary Auditory Neuropathy.

Objectives: Premature birth causes some permanent or temporary abnormalities in the hearing system of the newborn. Inadequate development of the central auditory nervous system and balance, as well as the delay in the formation of the nerve myelin, can be the cause of many hearing disorders, including permanent or temporary auditory neuropathy spectrum disorder (ANSD). The present study aims to identify and understand developmental delay disorder in the hearing system of infants and investigate the possibility of temporary auditory neuropathy in infants. Materials & Methods: In this comparative analytical study, twenty premature infants were randomly selected for hearing tests using auditory brainstem response and transient otoacoustic emissions at the time of discharge and three months after the first evaluation. The different components of these tests were analyzed and compared before and after developing the auditory system. Results: The OAEs test showed a signal-to-noise ratio above six dB with appropriate amplitudes in all infants. The grand average waveform of the ABR showed a significant difference between the amplitudes of waves III and V before and after maturation in both ears (p<0.05). In addition, the absolute latency of waves, specifically III and V, showed a significant difference between the two assessment times (0.05). Conclusions: The present study confirmed the occurrence of temporary ANSD or delayed maturation in premature infants following the lack of complete growth and myelination of auditory nerve fibers. There is a need to determine the hearing status of premature infants by frequent examinations and prevent any unnecessary prescription of amplifications.

Comparison of the efficacy of inhaled versus infused milrinone in the management of persistent pulmonary hypertension of the newborn in resource-limited settings: A randomized clinical trial.

BACKGROUND: The standard treatment for persistent pulmonary hypertension of the newborn (PPHN) is inhaled nitric oxide (iNO), which is not available in Iran. Consequently, other drugs, such as milrinone, are prescribed. So far, no study has investigated the effectiveness of inhaled milrinone in the management of PPHN. The present study aimed to improve the management of PPHN in the absence of iNO. METHODS: In this randomized clinical trial, neonates with PPHN, admitted to the neonatal intensive care unit of Hazrat Ali-Asghar and Akbar-Abadi hospitals, were treated with intravenous dopamine infusion and randomly divided into two groups, receiving milrinone through inhalation or infusion rout. The neonates were evaluated by Doppler echocardiography, clinical examinations, and oxygen demand test. The neonates were also evaluated for the clinical symptoms and mortality in the follow-up. RESULTS: A total of 31 infants, with a median age of 2 days (interquartile range = 4), were included in this study. There was a significant decrease in the peak systolic and mean pulmonary arterial pressure in both inhalation and infusion groups following milrinone administration, with no significant difference between the groups (p = 0.584 and p = 0.147, respectively). There was no significant difference between the two groups regarding the mean systolic blood pressure before and after treatment. Additionally, diastolic blood pressure was significantly lower in the infusion group after treatment (p = 0.020); however, the amount of reduction was not significantly different between the groups (p = 0.928). Overall, 83.9% of the participants achieved full recovery, 75% of whom were in the infusion group and 93.3% in the inhalation group (p = 0.186). CONCLUSION: Milrinone inhalation can have similar effects to milrinone infusion as an adjunct treatment in the management of PPHN. Also, infusion and inhalation of milrinone showed similar safety.

Association of lower vitamin a levels in neonates and their mothers with increased risk of neonatal late-onset sepsis: A case-control study.

BACKGROUND: In developing countries, neonatal sepsis is one of the major causes of mortality and morbidity. Vitamin A deficiency also affects the immune system severely and is associated with various neonatal infections. We aimed to compare maternal and neonatal vitamin A levels among neonates with and without late-onset sepsis. MATERIAL AND METHODS: 40 eligible infants were entered into this case-control study according to inclusion criteria. The case group included 20 term or near-term infants who had late-onset neonatal sepsis from three to seven days of life. The control group consisted of 20 term or near-term infants who were icteric hospitalized neonates without sepsis. Demographic, clinical and paraclinical features, as well as neonatal and maternal vitamin A levels, were compared between the two groups. RESULTS: The average gestational age of the neonates was 37.1 ± 1.2, ranging from 35 to 39 days. There was a significant difference between the septic and non-septic groups in terms of white blood cell and neutrophil count, C-reactive protein, and neonatal and maternal vitamin A levels. A Spearman correlation analysis showed a significant direct correlation among maternal and neonatal vitamin A levels (correlation coefficient = 0.507; P-value = 0.001). Multivariate regression analysis showed that neonates' vitamin A level had a significant direct association with sepsis (OR: 0.541; P-value=0.017). CONCLUSION: Our findings demonstrated the association of lower vitamin A levels in neonates and their mothers with an increased risk of late-onset sepsis, which emphasizes the importance of the consideration of vitamin A level evaluation and its appropriate neonatal and maternal supplementation.

Successful Management of Pan-Resistant Acinetobacter baumannii Meningitis without Intrathecal or Intraventricular Antibiotic Therapy in a Neonate.

Acinetobacter baumannii is one of the most important etiologies of nosocomial infections in recent years mainly because of increasing in frequency of multidrug and pan-resistant pathogens. Meningitis caused by this organism is a dilemma; because polymyxins are the only effective antibiotics against pan-resistant serotypes, but have poor penetration via blood brain barrier; however, it has still remained uncertain whether the intravenous therapy with these agents is an effective treatment with the sufficient concentration of the drug in the cerebrospinal fluid. Herein, we report a neonate who suffered from pan-resistant A. baumannii nosocomial meningitis successfully treated with intravenous colistin combined with meropenem and rifampin. It seems that intravenous colistin at least in combination with rifampin and meropenem might be considered as an option to try in patients in whom daily intrathecal injection or insertion of intraventricular device is not possible.

Accuracy of oxygen saturation index in determining the severity of respiratory failure among preterm infants with respiratory distress syndrome.

BACKGROUND: To evaluate the severity of respiratory failure among newborns with respiratory distress syndrome (RDS), oxygenation index (OI) has been implemented. In the present study, we assessed the accuracy of oxygen saturation index (OSI) in determining the severity of respiratory failure. METHODS: A cross-sectional study was carried out in the NICUs of two Iranian Hospitals (Tehran, Iran) in 2018. Preterm neonates with RDS entered the study. Immediately after admission, the severity of RDS was determined based on RDS scoring system. Then, 2 CC of arterial blood was withdrawn and sent to laboratory determining blood gases. Simultaneously, the level of peripheral capillary oxygen saturation (SpO2) was read using pulse oximeter and recorded. OI and OSI were measured using the formulae. Receiver Operating Characteristic curve, Kappa agreement coefficient and accuracy, sensitivity and specificity was used to compare the OI and OSI results. RESULTS: In the study, 95 neonates were considered. Based on ROC curves, the appropriate cut off with AUC = 0.99 for severe respiratory failure was OSI >8. The sensitivity, specificity, negative predicted value, and positive predicted value for the OSI Cut off >8 were 100, 98, 0.97 and 100%, respectively. The overall accuracy and Kappa agreement between OSI and OI was 0.96 and 0.98%, respectively. CONCLUSION: Our results showed that OSI with high sensitivity, specificity values could predict the severity of respiratory failure in preterm neonates with RDS.