Fabio Scopesi

Sustained Lung Inflation at Birth for Preterm Infants: A Randomized Clinical Trial

BACKGROUND: Studies suggest that giving newly born preterm infants sustained lung inflation (SLI) may decrease their need for mechanical ventilation (MV) and improve their respiratory outcomes. METHODS: We randomly assigned infants born at 25 weeks 0 days to 28 weeks 6 days of gestation to receive SLI (25 cm H2O for 15 seconds) followed by nasal continuous positive airway pressure (nCPAP) or nCPAP alone in the delivery room. SLI and nCPAP were delivered by using a neonatal mask and a T-piece ventilator. The primary end point was the need for MV in the first 72 hours of life. The secondary end points included the need for respiratory supports and survival without bronchopulmonary dysplasia (BPD). RESULTS: A total of 148 infants were enrolled in the SLI group and 143 in the control group. Significantly fewer infants were ventilated in the first 72 hours of life in the SLI group (79 of 148 [53%]) than in the control group (93 of 143 [65%]); unadjusted odds ratio: 0.62 [95% confidence interval: 0.38–0.99]; P = .04). The need for respiratory support and survival without BPD did not differ between the groups. Pneumothorax occurred in 1% (n = 2) of infants in the control group compared with 6% (n = 9) in the SLI group, with an unadjusted odds ratio of 4.57 (95% confidence interval: 0.97–21.50; P = .06). CONCLUSIONS: SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome compared with nCPAP alone but did not decrease the need for respiratory support and the occurrence of BPD.

A randomised control study comparing the Infant Flow Driver with nasal continuous positive airway pressure in preterm infants

OBJECTIVE To compare the effectiveness of the Infant Flow Driver (IFD) with single prong nasal continuous positive airway pressure (nCPAP) in preterm neonates affected by respiratory distress syndrome. DESIGN Randomised controlled study. PATIENTS Between September 1997 and March 1999, 36 preterm infants who were eligible for CPAP treatment were randomly selected for either nCPAP or IFD and studied prospectively for changes in oxygen requirement and/or respiratory rate. The requirement for mechanical ventilation, complications of treatment, and effects on mid-term outcome were also evaluated. RESULTS Use of the IFD had a significantly beneficial effect on both oxygen requirement and respiratory rate (p < 0.0001) when compared with nCPAP. Moreover, O2 requirement and respiratory rate were significantly decreased by four hours (p < 0.001 and p < 0.03 respectively). The probability of remaining supplementary oxygen free over the first 48 hours of treatment was significantly higher in patients treated with the IFD than with nCPAP (p < 0.02). IFD treated patients had a higher success (weaning) rate (94% v 72 %) and shorter duration of treatment (49.3 (31)v 56 (29.7) hours respectively; mean (SD)), although the difference was not significant. CONCLUSIONS IFD appears to be a feasible device for managing respiratory distress syndrome in preterm infants, and benefits may be had with regard to oxygen requirement and respiratory rate when compared with nCPAP. The trend towards reduced requirement for mechanical ventilation, shorter clinical recovery time, and shorter duration of treatment requires further evaluation in a multicentre randomised clinical trial.

Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome (SLI STUDY): study protocol for a randomized controlled trial

BackgroundSome studies have suggested that the early sustained lung inflation (SLI) procedure is effective in decreasing the need for mechanical ventilation (MV) and improving respiratory outcome in preterm infants. We planned the present randomized controlled trial to confirm or refute these findings.Methods/DesignIn this study, 276 infants born at 25+0 to 28+6 weeks’ gestation at high risk of respiratory distress syndrome (RDS) will be randomized to receive the SLI maneuver (25 cmH2O for 15 seconds) followed by nasal continuous positive airway pressure (NCPAP) or NCPAP alone in the delivery room. SLI and NCPAP will be delivered using a neonatal mask and a T-piece ventilator.The primary endpoint is the need for MV in the first 72 hours of life. The secondary endpoints include the need and duration of respiratory support (NCPAP, MV and surfactant), and the occurrence of bronchopulmonary dysplasia (BPD).Trial registrationTrial registration number:NCT01440868

Neonatal hearing screening model: An Italian regional experience

Objective. To produce a model for routine centralized hearing screening including all aspects of the screening, from diagnosis to psychological counseling and early rehabilitation. Methods. A prospective observational study on a geographically defined pediatric population (Liguria region, northwestern Italy) and data collection in a data bank. The model proposed was created for the audiological screening of all newborns of the Liguria region. The model includes four phases: (1) preliminary identification of contractual, administrative, legal aspects; (2) screening for identification of congenital hearing impairment; (3) therapy and rehabilitation of identified subjects and genetic analysis; (4) epidemiology, data management, and workload management. To test the feasibility of the model proposed and to establish the workload required according to the resources available in the regional health plan, we performed a pilot study on all infants born in four of the 13 regional birth centers of Liguria region from 1 April 2001 to 30 September 2001. Results. Out of the 3268 newborns enrolled during the 6-month pilot study, 3238 (99.1%) were screened with otoacoustic emissions (OAE), while screening was refused in 30 newborns (0.9%). OAE resulted in a ‘pass’ for 3180 newborns (98.2%) and a ‘refer’ in 58 (1.8%). The standard auditory brainstem response (ABR) test was performed in 156 newborns, 58 of them as a result of the ‘refer’ at the second OAE and 98 others at audiological risk. Results were positive or uncertain at first ABR in 45 patients. Workload was calculated on the basis of the data obtained in the pilot study to allocate financial and organizational resources. Conclusions. The results of the pilot study allowed project planning. We think that the screening model proposed is an example of how a regional organization can deliver improved quality care through a rationalization and optimization process.

Pulmonary interstitial emphysema in preterm twins on continuous positive airway pressure.

Unilateral pulmonary interstitial emphysema (uPIE) is a well-known condition that is usually observed as a complication in infants who undergo mechanical ventilation (MV). It is rather unusual for uPIE to occur during nasal continuous positive airway pressure (n-CPAP) [1]. We report herein preterm twins with uPIE on n-CPAP who were successfully managed by a conservative approach. Female, monochorionic twins were born at 31 weeks of gestation to a 28-year-old mother by cesarean section following premature rupture of the membranes. A course of betamethasone had been administered to the mother one week prior to delivery. Case 1 Apgar scores were 5 and 9 at 1 and 5 minutes, respectively. Mild tachydyspnea at birth was treated by n-CPAP (3 cmH2O) in the delivery room. Birth weight was 1200 g (510 centile), length was 36 cm (510 centile), and head circumference was 26.5 cm (10 centile). Due to persisting mild respiratory distress, n-CPAP (Infant Flow Driver, Electro Medical Equipment Ltd, Brighton, UK) was continued (FiO2 0.30; 4 cmH2O), with stable and satisfactory gas values during the first 24 hours. Echocardiography showed a patent ductus arteriosus, which was successfully treated with ibuprofen. A chest radiograph was taken at 24 hours of age and showed interstitial emphysema involving the left lung with herniation across the midline and a rightward shift of the mediastinum compressing the quite normal appearing right lung (Figure 1, panel A). The patient’s O2 dependency concomitantly worsened up to 0.5, and there was a mild increase in tachydyspnea. Radiography was again performed 2 hours later and showed that the lesions were gradually enlarging and were associated with a progressive worsening of the mediastinal shift to the right. A few hours later, severe respiratory deterioration abruptly occurred and an X-ray showed left pneumothorax (Figure 1, panel B). The infant was placed on MV and a chest tube was inserted into the left hemithorax. Antibiotic therapy was also started. Due to the evidence of uPIE, the patient was selectively intubated in the right mainstem bronchus and was positioned left side-down. An X-ray taken 8 hours later showed a substantial improvement in the affected lung (Figure 1, panel C). Twenty-four hours later the uPIE had almost completely resolved. At 5 days of age the chest drainage tube was removed and she was extubated (Figure 1, panel D). Case 2 Apgar scores were 5 and 8 at 1 and 5 minutes, respectively. Mild tachydyspnea at birth was treated by n-CPAP (3 cmH2O) in the delivery room. Birth weight was 1170 g (510 centile), length was 36 cm (510 centile), and head circumference was 24.5 cm (510 centile). Early respiratory distress syndrome (RDS) was treated in the neonatal intensive care unit (NICU) by n-CPAP (FiO2 0.3; 4 cmH2O) (Infant Flow Driver, Electro Medical Equipment Ltd, Brighton, UK). Clinical status remained stable over the next 36 hours. Echocardiography showed a patent ductus arteriosus, which was successfully treated with ibuprofen. On account of an increase in oxygen requirement (FiO2 up to 0.5), a slight worsening of tachypnea, and slow, progressive deterioration of blood gases, we took a chest X-ray at 36 hours of age, which revealed marked left interstitial emphysema with mediastinal shift to the right, while mild antero-lateral The Journal of Maternal-Fetal and Neonatal Medicine, October 2006; 19(10): 671–673

Design of a Portable Near Infra-Red Spectroscopy System for Tissue Oxygenation Measurement

A portable near-infrared spectroscopy (NIRS) system has been developed to provide real-time temporal and spatial information about the cutaneous tissue response to physiological stimulation. We describe the use of embedded technology, to realize the miniaturization of the NIRS system. On the platform of Windows CE and S3C2410 microprocessor, the paper introduces the process of designing and executing the equipment testing system from the viewpoints of both hardware and software. A detailed analysis of the implementation for tissue oxygenation measurement is described. The instrument design allows the collection of optical spectrum data with the use of a graphical user interface (GUI) based on a touch screen by using advanced ARM embedded techniques, making use of the abundant features of the ARM processor. The signal output is displayed as an image of oxy-haemoglobin and deoxy-haemoglobin concentration ([HbO 2 ], [HHb]) changes at a frame rate of 40 Hz. Experiments have been conducted on phantoms to determine the sensitivity of the system. The system has been tested in volunteers by imaging changes in forearm muscle oxygenation, following blood pressure cuff occlusion to obtain typical [HHb] and [HbO 2 ] plots. From the results of the experiments, the equipment is not only user-friendly but also portable, reliable and cost effective beyond the traditional equipment based on a PC.

Predictors of perinatal outcome in intrauterine growth retardation: a long term study.

UNLABELLED Fifty-three intrauterine retarded fetuses (IUGR) and seventy-five healthy pregnancies were monitored by neurobehavioural profile (quiet state or S1F and activity state or S2F percentages) and umbilical artery Doppler velocimetry (UA RI) on two occasions between the 27th-32nd and the 33rd-36th week of gestation. The aims of the present study were the following 1) to relate S1F, S2F and RI to mild and severe IUGR 2) to relate behavioural state analysis and UA Doppler velocimetry to the following perinatal outcomes: Cesarean section (CS); Preterm delivery (PD); small for gestational age (SGA); Apgar score at 1st and 5th min < 7; Respiratory Distress Syndrome (RDS); Neurological Injury (NI) (evaluated at the birth, the 4th, the 8th and the 12th month of life). 3) to establish the best predictors of perinatal outcome with these monitoring parameters by a stepwise computerized processing. Our results suggest: 1) mild IUGR, characterized by a progressive increase in peripheral vascular resistances, positive diastolic peak flow (RI: 0.72 +/- 0.01; mean +/- SD), is associated with gradual increase in S1F (12.51 +/- 2.84; mean +/- SD) and a decrease in S2F (27.51 +/- 2.81; mean +/- SD) percentages; 2) severe IUGR, characterized by zero or negative diastolic peak flow (UA RI-->1), is associated with a significant increase in S1F (21.32 +/- 12.11; mean +/- SD) and a decrease in S2F percentages (30.93 +/- 20.35; mean +/- SD). IN CONCLUSION S1F is the best predictor of severe IUGR and significant for all the perinatal outcomes selected; S2F is the best predictor of mild IUGR and significant for SGA; UA RI is the best parameter for recognizing mild IUGR and evolution to severe IUGR.

Preterm birth, respiratory failure and BPD: Which neonatal management?

Preterm birth is a significant problem in the world regarding perinatal mortality and morbidity in the long term, especially bronchopulmonary dysplasia (BPD). Premature delivery is often associated to failure in transition to create an early functional residual capacity (FRC), since many preterm babies need frequently respiratory support. The first and most effective preventive measure to reduce the incidence of BPD is represented by the attempt to avoid preterm birth. Whenever this fails, the prevention of every known risk factors for BPD should start in the delivery room and should be maintained in the NICU through the use of tailored management of high-risk infants.

Applied strategy for options of invasive and non-invasive sensors and instruments

A diverse range of sensors and instruments is available for use in the critical care of acutely ill patients and it is not always straightforward to decide which technologies should be used. Clinicians have their own priorities for the physiological variables that they consider need to be monitored in order to provide optimum medical care. Alongside this, consideration must be given to the choice of available technologies. This choice may be influenced by performance criteria, cost, and ease of use. It is also necessary to consider the physical status of the patients, the measurement instruments and any potential risks for the patients so as to provide the best measurement scheme. This paper explores the use of decision support tools that may be used in critical care situations. The care of ill newborn babies requiring mechanical ventilation is considered as a case study. The choice of invasive and non-invasive techniques for blood gas and pH assessment is evaluated and decision trees and hierarchical clustering are considered as possible decision support methodologies.

Sustained lung inflation to manage preterm infants (25–29 weeks' gestation) in the delivery room: the Italian SLI study

There is not a conclusive role of Sustained Lung Inflation (SLI) in the management of preterm infants at risk for RDS in the delivery room. This strategy would permit lung recruitment immediately after birth through delivery of brief peak pressure to the infant airways via a nasopharyngeal tube or mask allowing preterm infants to achieve FRC and reduce need of mechanical ventilation. We planned in Italy a randomized controlled trial (RCT) to confirm or refute these findings.