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1.
Trials ; 25(1): 433, 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38956676

ABSTRACT

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.


Subject(s)
Infant, Premature , Pulmonary Surfactants , Respiratory Distress Syndrome, Newborn , Female , Humans , Infant, Newborn , Airway Extubation/adverse effects , Bronchopulmonary Dysplasia/therapy , Continuous Positive Airway Pressure , Gestational Age , Intubation, Intratracheal , Multicenter Studies as Topic , Pulmonary Surfactants/administration & dosage , Randomized Controlled Trials as Topic , Respiratory Distress Syndrome, Newborn/therapy , Respiratory Distress Syndrome, Newborn/mortality , Time Factors , Treatment Outcome
3.
Clin Endocrinol (Oxf) ; 71(3): 346-50, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19178523

ABSTRACT

INTRODUCTION: The outcomes of different types of transitions of young people with chronic diseases have been poorly investigated. OBJECTIVE: To evaluate and compare a structured transition from the paediatric diabetes services (PDS) into the adult diabetic services (ADS) with an unstructured one. DESIGN: We retrospectively investigated 62 adolescents and young adults with type 1 diabetes discharged from the PDS from 1 January 1994 to 31 December 2004. Thirty-two patients (group A) were transferred to the ADS of the same hospital with an unstructured method (letter) and 30 patients after a structured transfer planned with adult physicians (group B). We analysed the date of the first admission in ADS, the glycated haemoglobin (HbA1c), the clinic attendance rate in PDS and in the first year in ADS, and a phone questionnaire on the transition experience. RESULTS: The duration of the transfer was longer in A than in B with a lack of medical assistance during the unstructured transition (P < 0.001). At the first visit in ADS, before any medical intervention, HbA1c was improved in B compared to the last in PDS (P < 0.01), and had a trend in worsening in A. After 1 year in the ADS there was a better clinical attendance, and a lower HbA1c in B than in A (P < 0.05). All the subjects of group B reported a favourable opinion for the structured transition (P < 0.0001). CONCLUSION: The transition process plays an important role in diabetic care and a structured plan is mandatory to avoid to lose the patients and to get worse their health.


Subject(s)
Diabetes Mellitus, Type 1/therapy , Patient Transfer/methods , Adolescent , Diabetes Mellitus, Type 1/metabolism , Female , Glycated Hemoglobin/metabolism , Humans , Patient Satisfaction , Pediatrics , Retrospective Studies , Surveys and Questionnaires , Young Adult
4.
Minerva Pediatr ; 59(6): 787-800, 2007 Dec.
Article in Italian | MEDLINE | ID: mdl-17978788

ABSTRACT

In this analysis of hematopoiesis, the regrowth of colony-forming cells in the bone marrow was examined in patients who had undergone medullary ablation and bone marrow transplant. The various stages of erythropoeisis and the factors that influence blood cell production are discussed: hematopoietic microenvironment, cytokines, tissue oxygen. Drawing on results from rodent and human studies, growth hormone factor (GH) function is explained, its interaction with insulin-like growth factors I and II (IGF I and II), and their effects on hematopoiesis. The aim of the study was to show the close link between GH, IGF I and II and erythropoiesis, because patients with GH deficit may present with partially impaired erythyroid proliferation that leads to the onset of anemia.


Subject(s)
Erythropoiesis/drug effects , Growth Hormone/pharmacology , Growth Hormone/administration & dosage , Humans , Somatomedins/drug effects
5.
Minerva Pediatr ; 59(4): 299-305, 2007 Aug.
Article in English | MEDLINE | ID: mdl-17947836

ABSTRACT

AIM: The aim of this paper was to test in teenagers with type 1 diabetes mellitus (T1DM) the Glucobeeb (Gb), a web based tool to support the diabetes care. METHODS: Gb transfers glucometer's data by phone and Internet to the PC of practitioner in files dedicated to each patient; the response returns to patient as 1-min vocal message. From outpatients paediatric clinic 28 teenagers (mean 14.8 years, range 10-20, male 14) with T1DM on multiple daily injections insulin therapy, with glicated haemoglobin (HbA1c) over 7% and >2 years' duration of the disease (9.1 years, range 2-15), were consequently randomized to telecare (glucometer transmission with feedback, group A) or control (standard communication by phone and face-to-face visits, group B). Glycaemia was tested four times per day and data transmitted every 2 weeks; clinician feedback returned within the following week. Two controls were excluded after randomization. Outcomes of 14 patients of A were compared with 12 of B. RESULTS: In intervention group average HbA1c% decreased from baseline at 3 and 6 months in comparison with controls (9.5, 9.0, 9.1, vs 9.1, 9.4, 9.4 respectively). Controls after 6 months were introduced to Gb, and similar trend of HbA1c was observed in the following examinations at 3 and 6 month (9.4, 8.9, 8.7). Then, in both groups HbA1c after 12 months of Gb increased, and after 18 reduced (A: 9.2, and 8.8, B 9.1 and 8.5 respectively). The enhancement of HbA1c from baseline to end was significant (P=0.01). CONCLUSION: The tool improves metabolic control in teenagers with T1DM.


Subject(s)
Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/therapy , Glycated Hemoglobin/analysis , Telemedicine , Adolescent , Adult , Child , Female , Humans , Male
6.
J Endocrinol Invest ; 28(7): 589-94, 2005.
Article in English | MEDLINE | ID: mdl-16218040

ABSTRACT

Entering puberty is one of the most important milestones in life. Studies from around the world have shown that age of pubertal changes onset can vary with race and ethnicity, environmental conditions, geographical location and nutrition. In the last century, the onset of puberty progressively shifted back towards younger ages in several European countries, with a levelling off in the last decades. The aim of our study was to describe the prevalence of secondary sexual characteristics in a group of children living in Northern Italy comparing them with the percentile values published by Tanner in 1976. We enrolled 3496 children drawn from public schools and evaluated height, weight and pubertal stages. The analysis of our data evidenced that the 50th percentile age of puberty onset in both sexes decreased by about 1 yr compared to data published by Tanner. Mean body mass index (BMI) z-score was significantly higher (p = 0.01) in pubertal than in pre-pubertal girls, on the contrary it was higher (p = 0.005) in pre-pubertal than in pubertal boys. In conclusion, our study found that girls and boys of our region are beginning pubertal development about 1 yr earlier than Tanner's British population. Taking into consideration the 3rd percentile age for Tanner's breast stage 2 in girls and testicular volume (TV) of 4 ml in boys, the current internationally used cut-off age for precocious puberty, i.e. 8 yr for girls and 9 yr for boys, can be maintained in our population.


Subject(s)
Puberty , Sex Characteristics , Age Factors , Breast/growth & development , Child , Cross-Sectional Studies , Female , Humans , Italy , Male , Puberty/physiology , Testis/anatomy & histology , Testis/growth & development , United Kingdom
7.
Minerva Pediatr ; 54(2): 147-51, 2002 Apr.
Article in English, Italian | MEDLINE | ID: mdl-11981529

ABSTRACT

In ENT practice, acute uncomplicated sphenoiditis is rarely diagnosed: very often diagnosis is involved for multiform and unspecific symptomatology, such as to sham nervous, visual and upper respiratory tract diseases. Only a careful differential diagnostics and an instrumental investigation consents to realise quickly a specific treatment, avoiding some complications, still frequent. This case-report, underlines that the polyspecialists' co-operation is necessary to make a correct diagnosis, and to avert important and dangerous complications into shapes of sphenoiditis.


Subject(s)
Sphenoid Sinusitis , Acute Disease , Child , Female , Humans , Sphenoid Sinusitis/complications , Sphenoid Sinusitis/diagnosis , Sphenoid Sinusitis/therapy
8.
Minerva Pediatr ; 53(6): 551-7, 2001 Dec.
Article in Italian | MEDLINE | ID: mdl-11740437

ABSTRACT

BACKGROUND: To evaluate the annual distribution of personal exposure to NO2 in a sample of school children and to study the determinants of such exposure. METHODS: Exposure to NO2 has been evaluated using Palmes Tubes in 310 school-children (aged 5-14) in Novara. The possible differences in personal measurements by means of ANOVA and Tuckey test were evaluated. Information on the sources of potential exposure and on respiratory symptoms have been collected through a questionnaire and a clinical diary. The relative risk for these variables has been assessed using a multiple regression model (Logit). RESULTS: The annual mean of the 6,200 measurements was 42.3 microgram/m3, with a significant difference among seasons and with higher values in winter. The only factor associated with a high exposure was identified for maternal school children living in houses close to high traffic density roads. Respiratory symptoms were non-related to NO2. CONCLUSIONS: The use of gas cookers and heaters is not enough to explain the variability of personal exposure. Between other specific determinants, the importance of living along busy streets, of ETS and of seasons explains the level of personal exposure. The opportunity of personal, rather than environmental, monitoring is confirmed, even if we stress the necessity of studying the short-term exposure to rapidly find clinical damages in the general population.


Subject(s)
Air Pollution, Indoor/analysis , Nitrogen Dioxide/analysis , Child , Humans
10.
Arch Latinoam Nutr ; 51(2): 195-8, 2001 Jun.
Article in Portuguese | MEDLINE | ID: mdl-11678052

ABSTRACT

The soybean cultivar BR 36 with conventional levels of trypsin inhibitors activity and the soybean line BRM95-5262, which was genetically selected to contain low activity of trypsin inhibitors were used for biological assays with rats. BR 36 and BRM95-5262 contained 40 and 20, and 30 and 20% of relative residual activity of trypsin inhibitors, respectively. The mean values of PER and NPR showed that treatments with crude soybeans were minor than treatments with soybean thermically processed. However, the treatments of thermically processed soybean did not showed significative differences (p > or = 0.05). When the trypsin inhibitors activity were 8.61 and 8.44 UIT/mg of samples or 20 and 30% of relative residual activity of cultivar BR 36 and line BRM95-5262, respectively, it was observed that mean values of PER and NPR were not significatives. The mean values of CDA and CDV of treatments with crude soybeans were minor than treatment with casein and similar to the treatments with soybean thermically processed. So, it can be concluded that the biological evaluation obtained with soybean protein were dependent of initial trypsin inhibitors activities and of its respective thermical treatment. There was advantage in the use of BRM95-5262 soybean line with low trypsin inhibitors activity.


Subject(s)
Glycine max/chemistry , Soybean Proteins/pharmacology , Trypsin Inhibitors/pharmacology , Animals , Biological Assay , Food Handling , Male , Rats , Rats, Wistar , Soybean Proteins/analysis , Trypsin Inhibitor, Kunitz Soybean/analysis , Trypsin Inhibitors/analysis
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