Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial.

BACKGROUNDS: Evaluating the efficacy of the loading and tapering dose of Phenobarbital versus oral Morphine in the management of NAS. METHODS: This randomized, open-label, controlled trial was conducted on 60 neonates born to illicit drugs dependent mothers at Vali-Asr and Akbar-Abadi hospitals, Tehran, Iran, who exhibited NAS requiring medical therapy. The neonates were randomized to receive either: Oral Morphine Sulfate or a loading dose of Phenobarbital followed by a tapering dose. The duration of treatment required for NAS resolution, the total hospital stay and the requirement for additional second line treatment were compared between the treatment groups. RESULTS: The Mean ± Standard Deviation for the duration of treatment required for the resolution of NAS was 8.5 ± 5 days in the Morphine group and 8.5 ± 4 days in the Phenobarbital group (P = 0.9). The duration of total hospital stay was 12.6 ± 5.6 days in the Morphine group and 12.5 ± 5.3 days in the Phenobarbital group (P = 0.7). 3.3 % in the Morphine group versus 6.6 % in the Phenobarbital group required adjunctive treatment (P = 0.5). CONCLUSIONS: There were no significant differences in the duration of treatment, duration of hospital stay, and the requirement for adjunctive treatment, between the neonates with NAS who received Morphine Sulfate and neonates who received a loading and tapering dose of Phenobarbital. TRIAL REGISTRATION: This study is registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) which is a Primary Registry in the WHO Registry Network. (Registration Number = IRCT201406239568N8 ).

Can we Replace Arterial Blood Gas Analysis by Pulse Oximetry in Neonates with Respiratory Distress Syndrome, who are Treated According to INSURE Protocol?

Neonates with respiratory distress syndrome (RDS), who are treated according to INSURE protocol; require arterial blood gas (ABG) analysis to decide on appropriate management. We conducted this study to investigate the validity of pulse oximetry instead of frequent ABG analysis in the evaluation of these patients. From a total of 193 blood samples obtained from 30 neonates <1500 grams with RDS, 7.2% were found to have one or more of the followings: acidosis, hypercapnia, or hypoxemia. We found that pulse oximetry in the detection of hyperoxemia had a good validity to appropriately manage patients without blood gas analysis. However, the validity of pulse oximetry was not good enough to detect acidosis, hypercapnia, and hypoxemia.

Comparison of Oral Acetaminophen Versus Ibuprofen in Premature Infants With Patent Ductus Arteriosus.

BACKGROUND: Patent ductus arteriosus (PDA) is a common cause of morbidity. The aim of this study was to compare the efficacy of oral Acetaminophen and oral Ibuprofen for the closure of patent ductus arteriosus (PDA) in preterm infants. OBJECTIVES: This study demonstrated that, there was no significant difference between treatment of PDA with either oral Acetaminophen or oral Ibuprofen in preterm neonates. PATIENTS AND METHODS: This clinical trial, randomized study, enrolled 120 infants, with a gestational age of < 37 weeks, who were admitted in neonatal intensive care unit of Afzalipour hospital, Kerman, Iran, in 2014. PDA was confirmed echocardiographically. The trial was registered in Iranian registry of clinical trials (Reg. No. 25542). Sixty-seven infants received oral Acetaminophen (15mg/kg every six hours for three days) and 62 infants received Ibuprofen (an initial dose of 20 mg/kg, followed by 10 mg/kg at 24 and 48 hours). To evaluate the efficacy of the treatment, a second echocardiography was done after completing the treatment. RESULTS: After the first course of the treatment, PDA closed in 55 (82.1 %) patients who received oral Acetaminophen vs. 47 (75.8 %) of those given oral Ibuprofen (P = 0.38). After the second course of treatment, PDA closed in 50 % of oral Acetaminophen group and 73.3% of oral Ibuprofen group (P = 0.21). CONCLUSIONS: This study demonstrated that, there was no significant difference between treatment of PDA with either oral Acetaminophen or oral Ibuprofen in preterm neonates. Oral Ibuprofen can effectively close PDA but is unfortunately associated with some adverse effects limiting its utility thus we studied an alternative drug with similar efficacy and less adverse effects. This study has recommends Acetaminophen with minimal complications for the treatment of PDA in preterm neonates instead of Ibuprofen.

Management of Neonatal Respiratory Distress Syndrome Employing ACoRN Respiratory Sequence Protocol versus Early Nasal Continuous Positive Airway Pressure Protocol.

OBJECTIVE: Respiratory distress syndrome (RDS) is a common cause of respiratory distress in premature infants. This study was designed to evaluate two different RDS treatment protocols by comparing the outcomes. METHODS: This study was a double center cross sectional study performed from June to December 2012. During that period, 386 neonates with RDS were hospitalized and treated according to two different therapeutic protocols so-called Acute Care of at-Risk Newborns (ACoRN) respiratory sequence protocol (group I) and Early Nasal Continuous Positive Airway Pressure (E-NCPAP) protocol (group II). The variables and main outcomes of this study were gestational age, birth weight, bronchopulmonary dysplasia (BPD), pulmonary hemorrhage (PH), intraventricular hemorrhage (IVH), air leak and mortality rate (MR). Findings : Out of 386 infants, 202 infants were in group I (male 60.4%, female 39.6%, mean gestational age 31(6/7) weeks, mean birth weight=1688 grams) and group II included 184 infants (male 61.4%, female 38.6%, mean gestational age 32 weeks, mean birth weight 1787 grams), P= 0.07. The ratios of BPD of group I to group II and PH of group I to group two were not significant (P=0.63 and P=0.84, respectively). Air leak ratio in group I was higher than in group II (P=0.001). Although IVH ratio in group II was higher than in group I (P=0.01), grade III and IV IVH was higher in group I (30% vs. 4.6%). In case of MR, it was higher in group I than in group II (P=0.001). CONCLUSION: According to the findings the incidence of air leak, grade III and IV IVH and MR was less common in E-NCPAP protocol, so it may show the effectiveness of this protocol. The authors suggest that more researches are needed for more accurate results.

Determining the correlation and accuracy of three methods of measuring neonatal bilirubin concentration.

OBJECTIVE: There are different methods for measuring bilirubin concentration; however, it is quite important for practitioners to know which method should be used in certain clinical situations. The present prospective study aimed to compare three different methods for measuring neonatal bilirubin concentrations. METHODS: All full term neonates who were either brought into emergency departments or admitted to the neonatal wards in Kerman city in 2011 were recruited (n = 428). The correlation coefficients were estimated for the routine ways of bilirubin concentrations including "Capillary", "Cutaneous" and "Laboratory" methods. FINDINGS: Of 428 recruited neonates, 178 were female. Mean age ±SD was 178±71 hours. The correlation coefficient for "David Icterometer" vs "JM103" was 0.91, while the corresponding coefficient for "David Icterometer" vs "Capillary" was 0.96. It was also equivalent to 0.85 for correlation between "JM103" and "Capillary" methods. The David Icterometer measured an average of 2.36 mg/dl levels of bilirubin concentration compared to the JM103 method. The Capillary method showed a lower bilirubin level than the venous concentration (0.91 mg/dl on average). Compared with the "Capillary", the "JM103" measured a slightly higher level of bilirubin with an average 0.57 mg/dl. CONCLUSION: Due to low difference (less than 1 mg/dl) between "JM103" and the "Capillary methods" for measurement of neonatal bilirubin concentration, these two methods could alternatively be used instead of usual laboratory method.

Distribution of retinopathy of prematurity and its risk factors.

OBJECTIVE: This study was conducted to determine the distribution and risk factors of retinopathy of prematurity (ROP) in premature infants referred to neonates intensive care unit (NICU) of central hospital of Kerman University of Medical Sciences, to obtain primary information on ROP in Kerman, Iran. METHODS: In a cross sectional prospective study, data of premature infants screened for ROP including possible risk factors and eye examination results were recorded during 2006-2008 and analyzed by using logistic regression and chi-square tests. FINDINGS: Out of 83 premature infants, 24 (29%) had different stages of ROP (CI 95%: 0.19-0.39). The infants' mean gestational age (GA) and mean birth weight (BW) in ROP group were 30.17±1.8 weeks and 1247.92±237.1 grams (g), respectively. Logistic regression analysis showed a significant relation between GA and BW with ROP (P<0.001). Indication for treatment was set in 6 (25%) infants. CONCLUSION: The results of this study illustrate a relatively high prevalence of ROP in this series. GA and BW were independent ROP determinants.

Bubble-CPAP vs. Ventilatory-CPAP in Preterm Infants with Respiratory Distress.

OBJECTIVE: Application of Continuous Positive Airway Pressure (CPAP) in neonate with respiratory distress is associated with reduction of respiratory failure, reduced complications and mortality. Bubble CPAP (B-CPAP) and ventilator-derived CPAP (V-CPAP) are two most popular CPAP modes. We aimed to determine whether B-CPAP and V-CPAP would have different survival rate and possible complications. METHODS: This prospective clinical trial was performed on 50 preterm neonates weighing 1000-2000 gr who were admitted to the neonatal intensive care unit of Afzalipoor Hospital because of respiratory distress between June 2009 and May 2010. Patients were randomly allocated into treatment groups using minimization technique. Survival analysis was applied to estimate and compare survival rates. Duration of oxygen therapy, hospital stay as well as hospitalization costs were compared using independent sample t-test. FINDINGS: Estimated survival rates at 24 hours in B-CPAP and V-CPAP groups were 100% and 77% respectively. Corresponding figures at 48 hours were 100% and 71%. In addition the hospitalization cost in V-CPAP group was significantly higher than in B-CPAP group. CONCLUSION: According to our results, B-CPAP was effective in the treatment of neonates who were suffering from respiratory distress and reduced the duration of hospital stay. In addition to mentioned benefits, its low cost may be the reason to use B-CPAP broadly compared with V-CPAP.