A multicenter randomized controlled trial comparing effectiveness of two nasal continuous positive airway pressure devices in very-low-birth-weight infants.

OBJECTIVE: Many studies suggest nasal continuous positive airway pressure is an effective and relatively complication-free means of respiratory support in premature infants. However, only limited data exist regarding the practical aspects of nasal continuous positive airway pressure delivery, including the best way to provide the positive airway pressure. DESIGN: Our aim was to compare the results of treatment using two different nasal continuous positive airway pressure devices: variable flow Infant Flow and constant flow nasal continuous positive airway pressure in two different groups of very-low-birth-weight infants in a multicenter randomized controlled trial. The indication groups were elective to avoid intubation and weaning from mechanical ventilation. SETTING: Twelve leading tertiary care neonatal centers in Poland. PATIENTS: Among 276 infants (weighing between 750-1500g, with a gestational age ≤32 wks) enrolled, 51% were randomized to receive Infant Flow and 49% to receive constant flow nasal continuous positive airway pressure. MEASUREMENTS AND MAIN RESULTS: Treatment success (i.e., no need for intubation/reintubation) occurred in 75% of our patients with a nonstatistically significant advantage seen with Infant Flow. The incidence of severe nasal complications and necrotizing enterocolitis were statistically significantly lower in the infants treated with Infant Flow. In our study, factors associated with elective nasal continuous positive airway pressure failure were birth weight ≤1000 g, gestational age ≤28 wks, clinical risk index for babies score >1, and PaO(2)/FIO(2) ratio of <150. Only birth weight ≤1000 g was associated with weaning failure. CONCLUSIONS: We found fewer severe nasal complications but no statistically significant advantage in treatment success in infants assigned to Infant Flow nasal continuous positive airway pressure compared with those assigned to constant flow nasal continuous positive airway pressure treatment. Significant risk factors of treatment failure include small size, maturity, and severity of respiratory distress syndrome.

Parental age as a risk factor for isolated congenital malformations in a Polish population.

Currently available data on the relationship between the prevalence of isolated congenital malformations and parental age are inconsistent and frequently divergent. We utilised the data from the Polish Registry of Congenital Malformations (PRCM) to accurately assess the interplay between maternal and paternal age in the risk of isolated non-syndromic congenital malformations. Out of 902 452 livebirths we studied 8683 children aged 0-2 years registered in the PRCM. Logistic regression was used to simultaneously adjust the risk estimates for maternal and paternal age. Our data indicated that paternal and maternal age were independently associated with several congenital malformations. Based on our data, young maternal and paternal ages were independently associated with gastroschisis. In addition, young maternal age, but not young paternal age, carried a higher risk of neural tube defects. Advanced maternal and paternal ages were both independently associated with congenital heart defects. Moreover, there was a positive association between advanced paternal age and hypospadias, cleft palate, and cleft lip (with or without cleft palate). No significant relationships between parental age and the following congenital malformations were detected: microcephaly, hydrocephaly, oesophageal atresia, atresia or stenosis of small and/or large intestine, ano-rectal atresia or stenosis, renal agenesis or hypoplasia, cystic kidney disease, congenital hydronephrosis, diaphragmatic hernia and omphalocele.

Comparative study of clinical characteristics of amniotic rupture sequence with and without body wall defect: further evidence for separation.

BACKGROUND: Amniotic rupture sequence (ARS) is a disruption sequence presenting with fibrous bands, possibly emerging as a result of amniotic tear in the first trimester of gestation. Our comparative study aims to assess whether there is a difference in the clinical pattern of congenital limb and internal organ anomalies between ARS with body wall defect (ARS-BWD) and ARS without BWD (ARS-L). METHODS: Among 1,706,639 births recorded between 1998 and 2006, 50 infants with a diagnosis of ARS were reported to the Polish Registry of Congenital Malformations. The information on 3 infants was incomplete, thus only 47 cases were analyzed. These infants were classified into groups of ARS-L (38 infants) and ARS-BWD (9 infants). RESULTS: The ARS-BWD cases were more frequently affected by various congenital defects (overall p < 0.0001), and in particular by urogenital malformations (p = 0.003). In both groups, limb reduction defects occurred in approximately 80% of cases; however, minor and distal limb defects (phalangeal or digital amputation, pseudosyndactyly, constriction rings) predominated in the ARS-L group (p = 0.0008). The ARS-L group also had a higher frequency of hand and upper limb involvement. CONCLUSIONS: This observation suggests that amniotic band adhesion in ARS-L takes place at a later development stage. Although limited by a small sample size, our study contributes to the growing evidence that both ARS entities represent two nosologically distinct conditions.

Introduction of Infant Flow nasal continuous airway pressure as the standard of practice in Poland: the initial 2-year experience.

OBJECTIVE: The aim of this prospective study was to evaluate whether a change in the standard of newborn care for respiratory insufficiency by widely introducing more aggressive use of nasal continuous airway pressure (nCPAP) and including Infant Flow technology would result in satisfactory outcomes. DESIGN: Prospectively defined analysis. SETTING: Fifty-seven secondary and tertiary care neonatal centers in Poland. PATIENTS: Patients were 1,299 newborns. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We carried out a prospectively defined analysis of 1,299 newborns included in the program between August 1, 2003, and April 30, 2005. The inclusion criterion was the occurrence of symptoms of respiratory failure irrespective of its etiology. Respiratory support was provided with the use of the Infant Flow Advance Driver. The analysis was made on data from prospectively designed questionnaires completed following each infant's treatment. Infants were placed into categories based on clinical indication for use. The primary end point was avoiding tracheal intubation. A high rate of acceptance of the new practice was observed across the substantial demographic and clinical diversity of newborns. Tracheal intubation was avoided in 78% of infants treated electively with nCPAP. Of those being weaned from mechanical ventilation, 61.2% were successfully weaned. Related complications were low (1.4% pneumothorax, 12% nasal injuries). CONCLUSIONS: The new method of nCPAP with Infant Flow was adopted as standard practice in Poland. We monitored its safety and effectiveness over a 2-yr period and found it to be safe and effective as implemented. Additional research is still needed to determine the optimum patient population, strategy for use, and devices.

[Evaluation of diagnostic value of procalcitonin (PCT) as a marker of congenital infection in newborns]. / Ocena wartosci oznaczania prokalcytoniny jako wykladnika zakazenia wrodzonego u noworodków.

UNLABELLED: Systemic bacterial infections still remain one of the major causes of neonatal morbidity and mortality. Early detection of neonatal sepsis can be difficult, because the first signs of the disease may be unspecific and similar to symptoms of other non-infectious processes. Procalcitonin became a new, sensitive marker of bacterial infections in newborns. The aim of our study was to assess the value of PCT as a diagnostic and prognostic tool of neonatal maternofetal infections. We also tried to estimate normal ranges of PCT in uninfected newborns. MATERIAL AND METHODS: 74 newborns, born in the Department of Obstetrics and Gynaecology, University of Medicine of Wroclaw, then hospitalized in the Department of Neonatology entered the study. They were divided into 2 groups: group 1-29 neonates with recognized materno-fetal infection, group 2-45 newborns without infection. In both groups blood samples to measure PCT concentrations were obtained by venipuncture on the 1st, 2nd, 3rd, 5th and between the 10th and 14th day of life (in the group of infected neonates) Sera were stored at -40 degrees C before analysis. PCT was determined using an immunoluminometric assay (BRAHMS Diagnostica). RESULTS: Serum procalcitonin values were significantly higher in the infected group than in the uninfected neonates (p < 0.001). The most significant differences were noted on the 2nd and 3rd day of life (p < 0.0001). After the treatment had been finished, the PCT levels in both groups were not statistically different. CONCLUSIONS: PCT is a useful tool in early diagnosing and monitoring the course of early-onset infections in neonates, particularly when blood cultures obtained from neonates remain negative. The decreasing concentrations of PCT level in children treated due to infection, indicate successful treatment and may help one to take a decision on termination of antibiotic therapy.

[Role of IVIG in modern neonatology]. / Rola IVIG we wspólczesnej neonatologii.

A newborn presents capacity to respond to specific antigens, but his immune system is still immature. Deficiency of immune function in the neonate is concerned with both innate and acquired immunity and provides to higher morbidity and mortality at this age of life. Therefore many multicentral studies on this field are performed. In the first part of the paper the authors present the development of humoral response and the role of immunoglobulins in infections of fetuses and newborns. The second part contains current views on immunoglobulin therapy in these children.