Study protocol: safety and efficacy of propranolol 0.2% eye drops in newborns with a precocious stage of retinopathy of prematurity (DROP-ROP-0.2%): a multicenter, open-label, single arm, phase II trial.

BACKGROUND: Retinopathy of prematurity (ROP) still represents one of the leading causes of visual impairment in childhood. Systemic propranolol has proven to be effective in reducing ROP progression in preterm newborns, although safety was not sufficiently guaranteed. On the contrary, topical treatment with propranolol eye micro-drops at a concentration of 0.1% had an optimal safety profile in preterm newborns with ROP, but was not sufficiently effective in reducing the disease progression if administered at an advanced stage (during stage 2). The aim of the present protocol is to evaluate the safety and efficacy of propranolol 0.2% eye micro-drops in preterm newborns at a more precocious stage of ROP (stage 1). METHODS: A multicenter, open-label, phase II, clinical trial, planned according to the Simon optimal two-stage design, will be performed to analyze the safety and efficacy of propranolol 0.2% eye micro-drops in preterm newborns with stage 1 ROP. Preterm newborns with a gestational age of 23-32 weeks, with a stage 1 ROP will receive propranolol 0.2% eye micro-drops treatment until retinal vascularization has been completed, but for no longer than 90 days. Hemodynamic and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions, as well as electrocardiogram and echocardiogram, will be periodically performed to investigate treatment safety. Additionally, propranolol plasma levels will be measured at the steady state, on the 10th day of treatment. To assess the efficacy of topical treatment, the ROP progression from stage 1 ROP to stage 2 or 3 with plus will be evaluated by serial ophthalmologic examinations. DISCUSSION: Propranolol eye micro-drops could represent an ideal strategy in counteracting ROP, because it is definitely safer than oral administration, inexpensive and an easily affordable treatment. Establishing the optimal dosage and treatment schedule is to date a crucial issue. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02504944, registered on July 19, 2015, updated July 12, 2016. EudraCT Number 2014-005472-29.

Lung Ultrasound for Diagnosing Pneumothorax in the Critically Ill Neonate.

OBJECTIVES: To evaluate the accuracy of lung ultrasound for the diagnosis of pneumothorax in the sudden decompensating patient. STUDY DESIGN: In an international, prospective study, sudden decompensation was defined as a prolonged significant desaturation (oxygen saturation <65% for more than 40 seconds) and bradycardia or sudden increase of oxygen requirement by at least 50% in less than 10 minutes with a final fraction of inspired oxygen ≥0.7 to keep stable saturations. All eligible patients had an ultrasound scan before undergoing a chest radiograph, which was the reference standard. RESULTS: Forty-two infants (birth weight = 1531 ± 812 g; gestational age = 31 ± 3.5 weeks) were enrolled in 6 centers; pneumothorax was detected in 26 (62%). Lung ultrasound accuracy in diagnosing pneumothorax was as follows: sensitivity 100%, specificity 100%, positive predictive value 100%, and negative predictive value 100%. Clinical evaluation of pneumothorax showed sensitivity 84%, specificity 56%, positive predictive value 76%, and negative predictive value 69%. After sudden decompensation, a lung ultrasound scan was performed in an average time of 5.3 ± 5.6 minutes vs 19 ± 11.7 minutes required for a chest radiography. Emergency drainage was performed after an ultrasound scan but before radiography in 9 cases. CONCLUSIONS: Lung ultrasound shows high accuracy in detecting pneumothorax in the critical infant, outperforming clinical evaluation and reducing time to imaging diagnosis and drainage.

Ventilation strategies for preventing oxidative stress-induced injury in preterm infants with respiratory disease: an update.

Reactive oxygen and nitrogen species are produced by several inflammatory and structural cells of the airways. The lungs of preterm newborns are susceptible to oxidative injury induced by both reactive oxygen and nitrogen species. Increased oxidative stress and imbalance in antioxidant enzymes may play a role in the pathogenesis of inflammatory pulmonary diseases. Preterm infants are frequently exposed to high oxygen concentrations, infections or inflammation; they have reduced antioxidant defense and high free iron levels which enhance toxic radical generation. Multiple ventilation strategies have been studied to reduce injury and improve outcomes in preterm infants. Using lung protective strategies, there is the need to reach a compromise between satisfaction of gas exchange and potential toxicities related to over-distension, derecruitment of lung units and high oxygen concentrations. In this review, the authors summarize scientific evidence concerning oxidative stress as it relates to resuscitation in the delivery room and to the strategies of ventilation.

Numerical assessment of a criterion for the optimal choice of the operative conditions in magnetic nanoparticle hyperthermia on a realistic model of the human head.

PURPOSE: This paper presents a numerical study aiming at assessing the effectiveness of a recently proposed optimisation criterion for determining the optimal operative conditions in magnetic nanoparticle hyperthermia applied to the clinically relevant case of brain tumours. MATERIALS AND METHODS: The study is carried out using the Zubal numerical phantom, and performing electromagnetic-thermal co-simulations. The Pennes model is used for thermal balance; the dissipation models for the magnetic nanoparticles are those available in the literature. The results concerning the optimal therapeutic concentration of nanoparticles, obtained through the analysis, are validated using experimental data on the specific absorption rate of iron oxide nanoparticles, available in the literature. RESULTS: The numerical estimates obtained by applying the criterion to the treatment of brain tumours shows that the acceptable values for the product between the magnetic field amplitude and frequency may be two to four times larger than the safety threshold of 4.85 × 10(8)A/m/s usually considered. This would allow the reduction of the dosage of nanoparticles required for an effective treatment. In particular, depending on the tumour depth, concentrations of nanoparticles smaller than 10 mg/mL of tumour may be sufficient for heating tumours smaller than 10 mm above 42 °C. Moreover, the study of the clinical scalability shows that, whatever the tumour position, lesions larger than 15 mm may be successfully treated with concentrations lower than 10 mg/mL. The criterion also allows the prediction of the temperature rise in healthy tissue, thus assuring safe treatment. CONCLUSIONS: The criterion can represent a helpful tool for planning and optimising an effective hyperthermia treatment.

Diagnostic accuracy and prognostic value of the CD64 index in very low birth weight neonates as a marker of early-onset sepsis.

OBJECTIVE: To assess the diagnostic and prognostic utility of CD64 expression as a marker of early-onset sepsis (EOS) in very low birth weight (VLBW) neonates. METHODS: Neutrophil CD64 expression (CD64 index) was assessed in 129 VLBW neonates within 72 h after birth. The accuracy of the CD64 index in predicting EOS was determined by receiver operating characteristic curve analysis. The relationship between the expression of the CD64 index and neonatal outcomes was evaluated by multivariate analysis. RESULTS: The highest performance of the CD64 index was achieved at 24 h after birth; accuracy, sensitivity, and negative predictive values were 0.85, 0.89, and 0.99, respectively, with a cut-off value of 2.4. The increased expression of CD64 index was significantly associated with subsequent infections (relative risk 1.54; 95% confidence interval 1.02-2.33). CONCLUSIONS: The CD64 index could be used as a reliable marker of EOS in VLBW neonates and it is an independent risk factor for late-onset infections.

Neutropenia in Preterm Infants.

BACKGROUND: The non-specific and antigen-specific components of host defense mechanisms are subject to the adaptation process in the neonate; however, the neutrophil quantitative and qualitative deficiency is one of the most significant causative factors of neonatal-increased vulnerability to infection. OBJECTIVE: To review the incidence and outcome of neutropenia of unknown cause in preterm infants. RESULTS: The incidence of early and late-onset idiopathic neutropenia of prematurity is significant. CONCLUSION: The low neutrophil counts respond quickly to G-CSF treatment; however, due to the low probability of septic complications, particularly in the late-onset neutropenia, a deep diagnostic approach and the potential hematopoietic growth factor treatment should be limited to the severe cases, such as a neutrophil count <500/µL, lasting for more than 2 days.

Antibiotic use in infants in the first year of life in five European countries.

AIM: To assess in infants the number of illness episodes treated with antibiotics and prescription rates in five European countries. METHODS: This study was embedded in a multicenter nutritional intervention study and was conducted in five European countries. Infants were followed until 1 year of age. Illness episodes and prescriptions of systemic antibiotics were recorded by the parents. RESULTS: Illness episodes were caused by upper respiratory tract infections (URTIs) in 55-64% and by otitis media (OM) in 2-6.8%. URTIs were statistically significant and more frequently treated with antibiotics in Italy (18.8%), and less frequently in Switzerland (1.4%). OM was statistically significant and less frequently treated with antibiotics in the Netherlands (55%) when compared to Italy (82%). The antibiotic prescription rate varied between countries, ranging from 0.2 to 1.3 prescriptions per infant per year. CONCLUSIONS: As the frequency of illness episodes did not differ between countries, other factors, such as physician's attitude, parental pressure or other socio-economic determinants, most likely play a role in antibiotic prescribing habits in the first year of life.

Do prebiotics reduce the number of fever episodes in healthy children in their first year of life: a randomised controlled trial.

The objective of the present study was to assess the effect of adding specific prebiotics to standard formula feeding on the number of fever episodes in the first year of life. In the present randomised, double-blind, placebo-controlled trial in seven centres in five West European countries, 830 healthy term infants, without a first-degree family history of allergic disease, of mothers who indicated to give only formula feeding were randomised either to receive a standard non-hydrolysed cows' milk-based formula to which a mixture of specific oligosaccharides was added (prebiotics group (PG)), or to receive a similar formula without oligosaccharides (control group (CG)). A separate reference group consisted of 300 breast-fed infants. The primary outcome was the number of fever episodes prospectively documented by the parents. There was no difference in the number of fever episodes between the PG (median value 1·19; 25th-75th percentile 0·09-2·34) and CG (1·16; 25th-75th percentile 0·06-2·38). The median number of fever episodes in the separate breast-feeding reference group was 1·24 (25th-75th percentile 0·51-3·45). There was no effect of adding specific prebiotics to standard formula feeding in reducing the number of fever episodes in the present study.

Reduced occurrence of early atopic dermatitis because of immunoactive prebiotics among low-atopy-risk infants.

BACKGROUND: Most infants developing atopic dermatitis have a low risk for atopy. Primary prevention of atopic dermatitis is difficult. OBJECTIVE: To assess the effect of supplementation of an infant and follow-on formula with prebiotic and immunoactive oligosaccharides on the occurrence of atopic dermatitis in the first year of life. METHODS: Healthy term infants from 5 European countries with low atopy risk were recruited before the age of 8 weeks, either having started with formula feeding or being on full breast-feeding (breast-feeding group). Formula-fed infants were randomized to feeding with a regular formula containing a specific mixture of neutral oligosaccharides and pectin-derived acidic oligosaccharides (prebiotic formula group) or regular formula without oligosaccharides (control formula group). RESULTS: A total of 414 infants were randomized to the prebiotic group and 416 infants to the control group. A total of 300 infants were followed in the breast-feeding group. Up to the first birthday, atopic dermatitis occurred in significantly fewer infants from the prebiotic group (5.7%) than from the control group (9.7%; P = .04). The cumulative incidence of atopic dermatitis in the prebiotic group was in the low range of the breast-feeding group (7.3%). In a Cox regression model, the rate of atopic dermatitis was significantly lower by 44% in the prebiotic group versus the control group (P = .04). The number needed to prevent 1 case of atopic dermatitis by supplementation of prebiotics was 25 infants. CONCLUSION: Formula supplementation with a specific mixture of oligosaccharides was effective as primary prevention of atopic dermatitis in low atopy risk infants.

Sensory Stimulation in the NICU Environment: Devices, Systems, and Procedures to Protect and Stimulate Premature Babies.

Prematurity deprives infants of the prenatal sensory stimulation essential to their correct development; in addition, the stressful environment of the NICU impacts negatively on their growth. The purpose of this review was to investigate the effects of NICU noise pollution on preterm infants and parents. We focused on the systems and projects used to control and modulate sounds, as well as on those special devices and innovative systems used to deliver maternal sounds and vibrations to this population. The results showed beneficial effects on the preterm infants in different areas such as physiological, autonomic, and neurobehavioral development. Although most of these studies highlight positive reactions, there is also a general acknowledgement of the current limits: small and heterogeneous groups, lack of structured variable measurements, systematic control groups, longitudinal studies, and normative values. The mother's presence is always preferred, but the use of music therapy and the devices analyzed, although not able to replace her presence, aim to soften her absence through familiar and protective stimuli, which is a very powerful aid during the COVID-19 pandemic.

Neonatal Respiratory Distress and Airway Emergency: Report of Two Cases.

We discuss two cases of congenital airway malformations seen in our neonatal intensive care unit (NICU). The aim is to report extremely rare events characterized by immediate respiratory distress after delivery and the impossibility to ventilate and intubate the airway. The first case is a male twin born at 34 weeks by emergency caesarean section. Immediately after delivery, the newborn was cyanotic and showed severe respiratory distress. Bag-valve-mask ventilation did not relieve the respiratory distress but allowed for temporary oxygenation during subsequent unsuccessful oral-tracheal intubation (OTI) attempts. Flexible laryngoscopy revealed complete subglottic obstruction. Postmortem analysis revealed a poly-malformative syndrome, unilateral multicystic renal dysplasia with a complete subglottic diaphragm, and a tracheo-esophageal fistula (TEF). The second case is a male patient that was vaginally born at 35 weeks. Antenatally, an ultrasound (US) arose suspicion for a VACTERL association (vertebral defects, anal atresia, TEF with esophageal atresia and radial or renal dysplasia, plus cardiovascular and limb defects) and a TEF, and thus, fetal magnetic resonance (MRI) was scheduled. Spontaneous labor started shortly thereafter, before imaging could be performed. Respiratory distress, cyanosis, and absence of an audible cry was observed immediately at delivery. Attempts at OTI were unsuccessful, whereas bag-valve-mask ventilation and esophageal intubation allowed for sufficient oxygenation. An emergency tracheostomy was attempted, although no trachea could be found on cervical exploration. Postmortem analysis revealed tracheal agenesis (TA), renal dysplasia, anal atresia, and a single umbilical artery. Clinicians need to be aware of congenital airway malformations and subsequent difficulties upon endotracheal intubation and must plan for multidisciplinary management of the airway at delivery, including emergency esophageal intubation and tracheostomy.

Fermented infant formula (with Bifidobacterium breve C50 and Streptococcus thermophilus O65) with prebiotic oligosaccharides is safe and modulates the gut microbiota towards a microbiota closer to that of breastfed infants.

BACKGROUND & AIMS: Microbiome-modulators can help positively steer early-life microbiota development but their effects on microbiome functionality and associated safety and tolerance need to be demonstrated. We investigated the microbiome impact of a new combination of bioactive compounds, produced by the food-grade microorganisms Bifidobacterium breve C50 and Streptococcus thermophilus ST065 during a fermentation process, and prebiotics in an infant formula. Tolerance and safety were also assessed. METHODS: An exploratory prospective, randomized, double-blind, controlled, multi-centre study was designed to investigate the effect of bioactive compounds and prebiotics (short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS) 9:1). Experimental formulas containing these bioactive compounds and prebiotics (FERM/scGOS/lcFOS), prebiotics (scGOS/lcFOS), or bioactive compounds (FERM), were compared to a standard cow's milk-based control formula (Control). Exclusively breastfed infants were included as a reference arm since exclusive breastfeeding is considered as the optimal feeding for infants. The study lasted six months and included visits to health care professionals at baseline, two, four and six months of age. Stool SIgA concentration was the primary study outcome parameter. RESULTS: There were 280 infants randomized over the experimental arms and 70 infants entered the breastfed-reference arm. Demographics were balanced, growth and tolerance parameters were according to expectation and adverse events were limited. At four months of age the median SIgA concentration in the FERM/scGOS/lcFOS group was significantly higher compared to the Control group (p = 0.03) and was more similar to the concentrations found in the breastfed-reference group. Bifidobacterium increased over time in all groups. The FERM/scGOS/lcFOS combination resulted in a microbiota composition and metabolic activity closer to the breastfed infants' microbiome. CONCLUSION: The FERM/scGOS/lcFOS combination showed a significant positive effect on SIgA levels. All formulas tested were associated with normal growth and were well-tolerated. Additionally, at four months of age the FERM/scGOS/lcFOS formula brought the microbiome composition and metabolic activity closer towards that of breastfed infants. CLINICAL TRIAL REGISTRY: Registration number NTR2726 (Netherlands Trial Register; www.trialregister.nl/).

Italian inter-society expert panel position on radiological exposure in Neonatal Intensive Care Units.

BACKGROUND: In the recent years, clinical progress and better medical assistance for pregnant women, together with the introduction of new complex technologies, has improved the survival of preterm infants. However, this result requires frequent radiological investigations mostly represented by thoracic and abdominal radiographs in incubators. This document was elaborated by an expert panel Italian inter-society working group (Radiologists, Paediatricians, Medical Physicists) with the aim to assist healthcare practitioners in taking choices involving radiation exposures of new-born infants and to provide practical recommendations about justification and optimization in Neonatal Intensive Care Units. The adherence to these practice recommendations could ensure a high quality and patient safety. More complex and less common radiological practice, such as CT scan or fluoroscopy have been excluded. METHODS: The consensus was reached starting from current good practice evidence shared by four scientific societies panel: AIFM (Italian Association of Physics in Medicine), SIN (Italian Neonatology Society), SIP (Italian Paediatric Society), SIRM (Italian Medical Radiology Society) in order to guarantee good standard practices for every professional involved in Neonatal Intensive Care Units (NICU). The report is divided into clinical and physical-dosimetric sections: clinical Indications, good practice in radiological exposures, devices, exposure parameters and modalities, patient positioning and immobilization, Reference Diagnostic Levels, operators and patient's radiation protection. Another important topic was the evaluation of the different incubators in order to understand if the consequences of the technological evolution have had an impact on the increase of the dose to the small patients, and how to choose the best device in terms of radiation protection. At the end the working group faced the problem of setting up the correct communication between clinicians and parents following the most recent indications of the international paediatric societies. RESULTS: Taking into account the experience and expertise of 10 Italian Centres, the guideline sets out the criteria to ensure a high standard of neonatal care in NICU about procedures, facilities, recommended equipment, quality assurance, radiation protection measures for children and staff members and communication on radiation risk. CONCLUSIONS: This document will allow a standardization of the approach to the exposures in NICU, although oriented to a flexible methodology.

Propranolol 0.2% Eye Micro-Drops for Retinopathy of Prematurity: A Prospective Phase IIB Study.

Background: Oral propranolol reduces retinopathy of prematurity (ROP) progression, although not safely. Propranolol 0.1% eye micro-drops administered to newborns with stage 2 ROP are well-tolerated, but not sufficiently effective. Methods: A multi-center open-label trial was conducted to assess the safety and efficacy of propranolol 0.2% eye micro-drops in newborns with stage 1 ROP. The progression of the disease was evaluated with serial ophthalmologic examinations. Hemodynamic, respiratory, biochemical parameters, and propranolol plasma levels were monitored. Demographic and perinatal characteristics, co-morbidities and co-intervention incidences, together with ROP progression, were compared with a historical control group in the same centers participating in the trial. Results: Ninety-eight newborns were enrolled and compared with the historical control group. Populations were not perfectly homogeneous (as demonstrated by the differences in the Apgar score and the different incidence rate in surfactant administration and oxygen exposure). The progression to ROP stage 2 or 3 plus was significantly lower than the incidence expected on the basis of historical data (Risk Ratio 0.521, 95% CI 0.297- 0.916). No adverse effects related to propranolol were observed and the mean propranolol plasma level was significantly lower than the safety cut-off of 20 ng/mL. Unexpectedly, three newborns treated with oral propranolol before the appearance of ROP, showed a ROP that was unresponsive to propranolol eye micro-drops and required laser photocoagulation treatment. Conclusion: Propranolol 0.2% eye micro-drops were well-tolerated and appeared to reduce the ROP progression expected on the basis of a comparison with a historical control group. Propranolol administered too early appears to favor a more aggressive ROP, suggesting that a ß-adrenoreceptor blockade is only useful during the proliferative phase. Further randomized placebo-controlled trials are required to confirm the current results. Clinical Trial Registration  The trial was registered at ClinicalTrials.gov with Identifier NCT02504944 and with EudraCT Number 2014-005472-29.

Antiinfective properties of human milk.

The unfavorable effects of neonatal immunodeficiency are limited by some naturally occurring compensatory mechanisms, such as the introduction of protective and immunological components of human milk in the infant. Breast-feeding maintains the maternal-fetal immunological link after birth, may favor the transmission of immunocompetence from the mother to her infant, and is considered an important contributory factor to the neonatal immune defense system during a delicate and crucial period for immune development. Several studies have reported that breast-feeding, because of the antimicrobial activity against several viruses, bacteria, and protozoa, may reduce the incidence of infection in infants. The protection from infections may be ensured either passively by factors with antiinfective, hormonal, enzymatic, trophic, and bioactive activity present in breast milk, or through a modulator effect on the neonatal immune system exerted by cells, cytokines, and other immune agents in human milk.

Music reduces pain perception in healthy newborns: A comparison between different music tracks and recoded heartbeat.

OBJECTIVES: To assess the effect of 3 musical interventions, as compared to no music, on the physiological response of healthy newborns undergoing painful medical procedures (Guthrie test and/or intramuscular antibiotic injections). METHODS: Prospective study of 80 full-term newborns, aged 1 to 3 days, randomly allocated to exposure to Mozart's Sonata for two pianos K.448, Beethoven's Moonlight Sonata, heartbeat sound recordings (70 bpm) or no music. Pain perception (evaluated using the Neonatal Infant Pain Scale), heart rate and oxygen saturation were measured 10 min before (T0), during (T1), 10 (T2) and 20 (T3) minutes after the interventions. RESULTS: Infants who were exposed to the three music interventions displayed a significant reduction in heart rate and in pain perception and an increase in oxygen saturation, as compared to the control group, which showed less modifications on stress measurements after painful medical procedures (F(3,76) = 6.40, p = .001, partial η2 = 0.20). CONCLUSIONS: Exposure to music and heartbeat sound recordings changes short-term physiological parameters in healthy newborns undergoing potentially painful procedures. The similar effect shown by the 3 interventions might be explained by the common characteristics of the sound shared by the various tracks. Further research is needed to investigate the impact of different types of music used in intervention, in order to develop guidelines and include music as a part of evidence-based strategies to promote the outcome for neonates.

Reference intervals of citrated-native whole blood thromboelastography in premature neonates.

BACKGROUND: Bleeding due to acquired coagulation disorders is a common complication in premature neonates. In this clinical setting, standard coagulation laboratory tests might be unsuitable to investigate the hemostatic function as they reflect the concentration of pro-coagulant proteins but not of anti-coagulant proteins. Thromboelastography (TEG), providing a more complete assessment of hemostasis, may be able to overcome some of these limitations. Unfortunately, experience on the use of TEG in premature neonates is very limited and, in particular in this population, reference ranges of TEG parameters have not been yet evaluated. AIMS: To evaluate TEG in preterm neonates, and to assess their reference ranges. METHODS: One hundred and eighteen preterm neonates were analyzed for TEG in a retrospective cohort study. Double-sided 95% reference intervals were calculated using a bootstrap method after Box-Cox transformation. TEG parameters were compared between early-preterm and moderate-/late-preterm neonates and between bleeding and non-bleeding preterm neonates. RESULTS: Comparing early-preterm with moderate-/late-preterm neonates, TEG parameters were not statistically different, except for fibrinolysis which was significantly higher in early preterm neonates. Platelet count significantly correlated with α angle and MA parameters. Bleeding and non-bleeding neonates had similar TEG values. CONCLUSIONS: These results reinforce the concept that in stable preterm neonates, in spite of lower concentration of pro- and anti-coagulants proteins, the hemostasis is normally balanced and well functioning.

Neonatal morbidity after cesarean section before labor at 34(+0) to 38(+6) weeks: a cohort study.

OBJECTIVE: To describe morbidity in neonates born by cesarean section (CS) before labor between 34(+0) and 38(+6) weeks, stratified by gestational age. METHODS: Cohort study from five Italian tertiary care hospitals. Consecutive singleton pregnancies delivered by CS before labor between 34(+0) and 38(+6) weeks of gestation from January 2010 to August 2011 were included. Women in labor, with premature rupture of membranes, or with previous administration of steroids were excluded. The incidence of neonatal complication by gestational week was calculated. RESULTS: A total of 1135 cases were analyzed. Composite adverse neonatal outcomes, respiratory distress syndrome, transient tachypnea and use of continuous airway positive pressure decreased from 50%, 28%, 5% and 22% at 34 weeks of gestation, to 4.7%, 1.0%, 0.9% and 0.3% at 38 weeks of gestation. Multivariate analysis showed that the only variable independently associated with composite adverse neonatal outcome was gestational age at delivery (adjusted odds ratio 0.49; 95% confidence interval 0.39-0.61). CONCLUSIONS: The prevalence of neonatal complications in newborns delivered by CS before labor halves at each week of gestation from 34 to 38 weeks. Nonetheless complications, and mainly respiratory problems, are still present at early term gestation.

Nasal bilevel vs. continuous positive airway pressure in preterm infants.

Our aim was to compare the effects of nasal bilevel positive airway pressure (N-BiPAP) and nasal continuous positive airway pressure (N-CPAP) on gas exchange in preterm babies. Twenty preterm infants (mean gestational age, 26.3 weeks; mean weight at study, 1,033 g) were evaluated. Patients received two repeated cycles of N-CPAP alternated with N-BiPAP, for a total of four alternated phases, each phase lasting 1 hr. Transcutaneous PO2 (TcPO2), transcutaneous PCO2 (tcPCO2), pulsoximetry, and respiratory rate were recorded every 15 min. Arterial blood gases and acid-base balance were measured at the beginning of the first study period on baseline CPAP and at the end of the last study period on bilevel positive airway pressure. During the two N-BiPAP phases, a statistically significant (P < 0.001) increase of peripheral oxygen saturation and tcPO2, and a significant (P < 0.001) reduction of tcPCO2 and respiratory rate, were noted as compared to the two N-CPAP periods. In addition, a significant improvement of PO2 (P < 0.003) and a reduction of PCO2 were noted at the end of the test (P < 0.02). In conclusion, N-BiPAP, as compared to N-CPAP, improved gas exchange in preterm infants.