Comparison of "IN-REC-SUR-E" and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial).

BACKGROUND: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. METHODS: In this study, 382 infants born at 24+0-27+6 weeks' gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks' postmenstrual age. The secondary outcomes are BPD at 36 weeks' postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24+0 to 25+6 weeks or 26+0 to 27+6 weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). DISCUSSION: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24+0-27+6 weeks' gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks' postmenstrual age of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.

New high intensity fibreoptic phototherapy devices in healthy newborns: a single pad wrapped around the neonate body in comparison with a double pad device.

BACKGROUND: Fibreoptic Phototherapy (FPT) allows to lower total serum bilirubin (TSB) levels in healthy neonates maintained in rooming-in with their mothers. The 2004 Cochrane review showed that, differently from preterm neonates, FPT was not as effective as traditional phototherapy in term neonates (TN), unless the simultaneous utilization of two FPT devices. Aim of this study was to compare the efficacy of two FPT devices, both equipped with a single light-emitting diode (LED): the first one has a single large pad wrapped around the infant body (Bilisoft, GE Health Care) (device A), the second one is a double-pad phototherapy device (BiliCocoon, CremascolieIris) (device B). METHODS: We studied 172 healthy neonates with non-hemolytic hyperbilirubinaemia: 57 TN and 57 late preterm neonates (LPN) treated with device A (Group 1); 47 TN and 11 LPN treated with device B (Group 2). We evaluated the differences between groups by the Student's t-test for continuous variables and by chi square test for categorical data. A two tailed p < 0.05 was considered significant. RESULTS: There were no differences in term of duration of FPT, TSB hourly reduction, percentage of TSB reduction after FPT, TSB maximum rebound, percentage of TSB increase after FPT discontinuation and number of after-discharge checks. Two neonates treated with device B showed no decrease in TSB values during FPT. Seven infants treated with device B experienced hyperpyrexia. CONCLUSIONS: The two LED FPT devices were both effective in lowering TSB either in TN or LPN. Device A was effective in all treated neonates without negative side effects during treatment; device B was effective in all but 2 infants and 12% of the neonates in the same group experienced hyperpyrexia. According to our results, the single big pad wrapped around the infant body has the same efficacy as a double FPT device in TN and LPN.

Draft genome of the fungicidal biological control agent Burkholderia anthina strain XXVI.

Burkholderia anthina XXVI is a rhizosphere bacterium isolated from a mango orchard in Mexico. This strain has a significant biological control activity against the causal agent of mango anthracnose, Colletotrichum gloeosporioides, likely through the production of siderophores and other secondary metabolites. Here, we present a draft genome sequence of B. anthina XXVI (approximately 7.7 Mb; and G + C content of 67.0%), with the aim of gaining insight into the genomic basis of antifungal modes of action, ecological success as a biological control agent, and full biosynthetic potential.

Are high cumulative doses of erythropoietin neuroprotective in preterm infants? A two year follow-up report.

BACKGROUND: Preterm infants are at risk for neurodevelopmental sequelae even in absence of major cerebral lesions. The hypothesis that Human Recombinant Erythropoietin (rEpo) could improve the neurodevelopmental outcome in risk neonates has raised the highest interest in recent years. METHODS: A group of preterm neonates born at a gestational age ≤ 30 weeks and free from major cerebral lesions or major visual impairment, were included in the study if they had a complete neurologic evaluation for at least 24 months of postmenstrual age. They were assigned to group I in the case they had been treated with rEpo or group II if untreated. The aim was to evaluate whether rEpo, given at the high cumulative doses utilized for hematologic purposes, is able to improve the neurodevelopmental outcome in preterm infants born at a gestational age ≤ 30 weeks. A group of 104 preterm neonates were studied: 59 neonates who received rEpo for 6.9 ± 2.4 weeks at a median cumulative dose of 6300 UI/Kg (6337 ± 2434 UI/Kg), starting at a median age of 4 days and 45 neonates who were born in the period preceding the routine use of rEpo. The neurodevelopmental quotient at 24 month postmenstrual age was assessed utilizing the Griffiths' Mental Developmental Scales. RESULTS: Our results failed to show any difference in the Developmental Quotient at 24 month. Bronchopulmonary dysplasia, minor intraventricular hemorrhages and blood transfusions were the clinical features significantly related to the Developmental Quotient. CONCLUSIONS: Our results do not support the hypothesis that rEpo, administered with the schedule utilized for hematologic purposes, improve the neurodevelopmental outcome of preterm neonates, at least those preterm infants free from major impairments.

Hyperbilirubinemia in healthy newborns born to immigrant mothers from southeastern Asia compared to Italian ones.

OBJECTIVE: To compare the characteristics of jaundice and hyperbilirubinemia in the newborn population of both immigrant and Italian mothers. METHODS: The authors studied a group of 1,680 infants born at "A. Gemelli" hospital during 1 y. All were with appropriate weight for gestational age, weighting more than 2,500 g, born to low-risk pregnancy. Maternal ethnicity, clinically evident jaundice (that is total serum bilirubin (TSB) > 7 mg/dL), hyperbilirubinemia (TSB > 12 mg/dL), the duration of hospital stay and their need of phototherapy were evaluated. RESULTS: In infants born to Asian mothers, hyperbilirubinemia was significantly more frequent (48.8 % vs. 26.5 %, p = 0.003) and they reached mean TSB peak significantly later (86.5 ± 38.5 vs. 74.5 ± 20.6 h, P = 0.0001) compared with Italian infants. The average length of hospitalization of infants of Asian and Latin American mothers is significantly longer compared to Italian newborns (4.5 ± 1.9 vs. 3.6 ± 1.1, p <0.0001 and 4.2 ± 1.6 vs. 3.6 ± 1.1, p = 0.0004). With regard to the use of phototherapy, and to its duration, there are no significant differences between the populations studied. CONCLUSIONS: Having studied all infants at low risk, the greater length of hospitalization is due to later peak and the higher frequency of jaundice in newborns of immigrant mother, especially in Asia. Therefore, as it happens to the Italian newborns, it would be desirable to build forecasting nomograms in these populations, to reduce the length of hospitalization and facilitate protected discharge.

Brain CT scan for pediatric minor accidental head injury. An Italian experience and review of literature.

PURPOSE: Every year 300,000 children with accidental head trauma are admitted to Italian emergency departments. Our aims were: (1) to describe patients with minor traumatic brain injury who were admitted to pediatric departments and underwent CT, and (2) to analyze the appropriateness of management according to current guidelines. METHODS: We retrospectively analyzed patients with minor head injury (median age 4.5 years, range 1 month to 16 years) who were admitted to the pediatric department of the Catholic Medical School of Rome, from January 2005 to September 2010, who performed head CT. Univariate analysis was performed using the Fisher's exact test. Multivariate analysis was performed by logistic regression. RESULTS: One hundred and seventy-four patients were enrolled in the study. Fifty-four patients (31%) had pathological CT findings. Eight patients underwent neurosurgical treatments. Vomiting was the only symptom significantly prevalent in the infant group, compared to the children group (10.7% vs. 38.9%, p = 0.007), while loss of consciousness in the children group (50.0% vs. 25.0%, p = 0.040). The relationship between scalp swelling and CT abnormalities was statistically significant in the entire population. The incidence of head abnormalities was significantly higher in children with abnormal CT (92.6% vs. 72.5%). CONCLUSIONS: The best way to manage children with minor head trauma is still matter of debate. Loss of consciousness and scalp swelling are risk factors predicting brain injury that deserve CT control. The radiation risks posed by CT scanning in children must be balanced by the benefits. We believe that even though CT scans may be clinically unnecessary in many cases, the rate of scanning is justified by the even limited number of abnormalities which require neurosurgical treatment.

Target fraction of inspired oxygen during open lung strategy in neonatal high frequency oscillatory ventilation: a retrospective study.

BACKGROUND: There is no agreement to define the target FiO2 to adopt in the lung recruitment phase during HFOV in preterm infants. We report our experience of an optimal lung volume strategy (OLVS), defined as FiO2≤0.25 during the recruitment phase, in a cohort of neonates with gestational age (GA) ≤27 weeks treated with elective HFOV for respiratory distress syndrome (RDS) between July 2006 and September 2008. METHODS: FiO2 used during the recruitment phase was different according to physician' evaluation. 51 newborns were then divided into two groups: patients reaching FiO2≤0.25 (OLVS Group, N.=28), and patients reaching FiO2>0.25 (No-OLVS Group, N.=23). RESULTS: Prior to surfactant administration OLVS Group, respect to No-OLVS Group, received a significantly higher continuous distending pressure (CDP): 12.8±1.1 cmH2O vs 11.2±1.3 cmH2O (P<0.0001) and a significantly lower FiO2: 0.25±0.01 vs 0.35±0.06 (P<0.0001). A multivariate modeling approach confirmed that OLVS was significantly associated to the need for less surfactant doses (OR 0.19[95% CI 0.05-0.84]), a decreased risk of ductus arteriosus surgically ligated (OR 0.13[95% CI 0.02-0.86]) and to a lower number of ventilation hours before extubation: -152 (95% CI -284- -20). CONCLUSION: OLVS to fully recruit the lungs achieving FiO2≤0.25 during elective HFOV is associated with better short-term pulmonary outcomes respect to a strategy where the patients received a FiO2>0.25 during the recruitment phase. Utilizing HFOV in this way provides a more effective means to recruit and protect acutely injured lungs.

Ibuprofen lysinate and sodium ibuprofen for prophylaxis of patent ductus arteriosus in preterm neonates.

This retrospective, study compared the efficacy and safety of Ibuprofen-Lysinate (Arfen, intramuscular formulation, Group I, n=156) used during 2000-2005 and Sodium-ibuprofen (Pedea, intravenous solution, Group II, n=60) used during 2006-2008, for the prophylaxis of Patent Ductus Arteriosus in inborn neonates with gestational age ≤ 28 weeks. Ductus closure rate after prophylaxis was significantly higher (73.1% vs 50%; P=0.002) and surgical ligation significantly lower (8.2% vs 23.3%; P=0.005) in Group I. A smaller number of neonates of Group I vs Group II showed oliguria and hemorrhagic disease.

Urinary aldosterone excretion and electrolytic balance in response to chronic diuretic therapy in very low-birth weight infants.

BACKGROUND: It has been reported that the reninangiotensin- aldosterone system of healthy newborn infants and pre-term infants responds to acute furosemide challenge. OBJECTIVE: To assess urinary aldosterone excretion (UAE) and electrolytic balance in very low-birth weight (VLBW) infants who received chronic therapy with furosemide and to compare them with those of infants who did not receive diuretic therapy. METHODS: Infants with birth weight <1500 g were considered eligible for this prospective observational study. On the 10th day of life, infants enrolled were divided in 2 groups on the basis of our predictive score for chronic lung disease (CLD): group 1, with positive score, received furosemide and group 2, with negative score, did not receive diuretic therapy. Urinary aldosterone and electrolytes excretion, electrolytes intakes and clearance of creatinine were investigated before the beginning of the treatment and then weekly until discharge in both groups, and results were compared. RESULTS: Thirty infants were studied: 15 received long-term furosemide and 15 did not. UAE progressively increased in infants who received furosemide whereas remained unchanged in infants who did not receive treatment. UAE was greater in group 1 than in group 2 after 3 weeks of diuretic treatment, reaching statistical significance after 4 weeks of treatment. CONCLUSIONS: In VLBW infants, chronic therapy with furosemide leads to a progressive increase in UAE that may potentially limit the diuretic effect of long-term use of furosemide in the management of CLD.

Role of probiotics in the prevention of the enteric colonization by Candida in preterm newborns: incidence of late-onset sepsis and neurological outcome.

OBJECTIVE: To evaluate the efficacy of probiotics in the prevention of gastrointestinal colonization by Candida species, of late-onset sepsis and neurological outcome in preterm newborns. STUDY DESIGN: A prospective study was conducted in 249 preterms who were subdivided into three groups: one group (n=83) was supplemented with Lactobacillus (L.) reuteri, one group with L. rhamnosus (n=83) and the other with no supplementation (n=83). The fungal colonization in the gastrointestinal tract, the late onset of sepsis and clinical parameters were recorded. A neurological structured assessment was further performed at 1 year of age. RESULT: Candida stool colonization was significantly higher (P<0.01) in the control group than in the groups treated with probiotics. The L. reuteri group presented a significantly higher reduction in gastrointestinal symptoms than did the L. rhamnosus and control groups. Infants treated with probiotics showed a statistically significant lower incidence of abnormal neurological outcome than did the control group. CONCLUSION: The use of both probiotics seems to be effective in the prevention of gastrointestinal colonization by Candida, in the protection from late-onset sepis and in reducing abnormal neurological outcomes in preterms.

Neonatal hyperthyroidism: neonatal clinical course of two brothers born to a mother with Graves-Basedow disease, before and after total thyroidectomy.

BACKGROUND: About 1-2% of infants born to mothers with Graves' disease or Hashimoto's thyroiditis develop neonatal hyperthyroidism because of transplacental passage of IgG stimulating TSH receptors (TRAb). OBJECTIVE: To evaluate the effect of maternal total thyroidectomy on neonatal clinical course. METHODS: We describe two brothers born to a mother with Graves' disease, before and after total thyroidectomy. RESULTS: The first child showed persistent tachycardia, the presence of TRAb and a laboratory pattern of hyperthyroidism. Lugol's solution was started and then propylthiouracil was added. Digitalis, furosemide and diazepam were necessary for treatment of heart failure, hypertension and irritability. On the 70th day of life, hormone serum levels normalized and treatment was interrupted. TRAb normalized by the third month of life. The second infant was born 2 years after the mother underwent total thyroidectomy. In spite of a laboratory pattern of hyperthyroidism and positivity to TRAb, he showed only considerable weight loss, and no therapy was required. CONCLUSIONS: TRAb may persist after total thyroidectomy: clinical and instrumental follow-up of the newborn is recommended.

Mild and transient neutropenia in an infant of mother with Wegener's granulomatosis.

A case of a pregnancy occurring in a woman with previously diagnosed Wegener's granulomatosis and the following neonatal follow-up are described. Complete clinical and laboratory disappearance of disease activity was achieved by steroid treatment before pregnancy. The newborn was followed up for 6 months; he always showed normal clinical and laboratory exams, except a mild and transient neutropenia.

Hemispherectomy procedures in children: haematological issues.

OBJECTS: In literature, excessive perioperative haemorrhage and related haemodynamic instability have been described as major risk factors in hemispherectomy. In this report we analyse the impact of neurosurgical operation on both the haematological and coagulative patterns of these children, especially focusing on younger patients. METHODS: From 1993 to 2003, 18 consecutive children suffering from intractable epilepsia and treated by hemispherectomy were admitted to the Pediatric Intensive Care Unit (PICU) of Catholic University Medical School, Policlinico Gemelli, Rome. Eight children had an entire hemisphere removed (anatomical hemispherectomy), whereas the remaining 10 underwent disconnective procedures (functional hemispherectomy) or cerebral cortex ablations (e.g. hemicorticectomy). Eleven out of these 18 children underwent hemispherectomy because of hemimegalencephaly (HME): their mean age was 14.5 months (range 3-56 months); non-HME patients underwent surgery for epileptogenic lesions involving the cerebral hemisphere to a great extent or diffusely. Data have been compared with an historical cohort of 13 children operated on before 1992 at the same institution comparable for age, aetiology of epilepsy and the modalities of surgical operation. CONCLUSIONS: Blood losses and haemotransfusions showed a profound influence on the haematologic/coagulative status of the children operated upon. A strict correlation was demonstrated between estimated red cell volume (ERCV) loss and haemostatic impairment in this series. Recent surgical techniques appear to reduce blood losses and related haemocoagulative risks even in younger patients.

[Neonatal lupus: different clinical neonatal expression in siblings]. / Lupus néonatal: une fratrie de nouveau-nés avec différentes expressions cliniques.

Neonatal Lupus Syndrome is a rare disease caused by placental passage of maternal autoantibodies. Pathogenesis is partially unknown and many clinical manifestations are possible. We report on newborn siblings who presented with different symptoms of Neonatal Lupus Syndrome. One patient presented with congenital heart block and another with hepatic and haematologic involvement. Cases of Neonatal Lupus among siblings are very rare, because of the high risk of pregnancy in affected women. Various clinical expressions may be explained by a different specificity of Anti-Ro autoantibodies among siblings. The reported cases are commented with regard to recent literature, trying to explain their pathogenesis.

[Alimentary strategies in the neonatal period in the prevention of allergies]. / Strategie alimentari nella prevenzione dell'allergia in età neonatale.

The Authors report an update relative to the dietetic prevention strategies in the high allergic risk subject, as proposed from more recent literature. The babies with a familiar history of atopia are defined as population with allergic risk. The Authors examine the role of early exposure to cow's milk formulas and maternal diet during breast-feeding as risk factors for allergic symptoms in such babies. Moreover, they examine the indications for hydrolisated milk (partial and extensive) formulas and soy milk formulas use, as reported in published Meta-analysis and official statements of several Scientific Associations. They conclude that beyond the undoubted preventive role of exclusive breast-feeding in the first 4-6 month after birth, and of the extensively hydrolisated formulas, there are many concerns about the role for partially hydrolisated formulas and soy formulas. The Authors claim for multicentric methodologically correct trials in order to clear the controversies.

The effects of cosmic particle radiation on pocket mice aboard Apollo XVII: III. Dosimeter design, construction, and implantation.

To detect the passage of cosmic ray particles through the heads of the pocket mice during the Apollo XVII flight, a "monitor" (dosimeter) composed of plastics was prepared and implanted under the scalp. The monitor was mounted on a platform, the undersurface of which fitted the contour of the skull. Numerous tests were run to assure that the presence of the monitor assembly beneath the scalp would be compatible with the well-being of the mice and that the capacity of the monitor to detect the traversal of cosmic ray particles would be preserved over the several weeks during which it would remain under the scalp.