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The Multi-center Epidemiologic Study Of Preterm Infants And The Evaluation Of A Neonatal Stabilization Program

Posted on:2014-01-19Degree:DoctorType:Dissertation
Country:ChinaCandidate:X L MaFull Text:PDF
GTID:1264330401987369Subject:Academy of Pediatrics
Abstract/Summary:PDF Full Text Request
In China, the neonatal mortality reported by the Ministry of Health in2011was7.8%o. The major causes of death were preterm, low birth weight, and preterm related complications. During the past20years, modern perinatal-neonatal care has emerged dramatically in China. Major tertiary centers with neonatal intensive care unit (NICU) are established mainly in provincial and subprovincial cities. Although the mortality of very low birth weight infant (VLBWI) has decresed significantly, there is still a wide gap behind the developed countries. Therefore, how to reduce the mortality and morbidity of preterm infants is still the focus today in perinatal medicine.With the establishment of multi-center collaborative network in developed countries, some randomized controlled trials with large sample size were conducted. Results of these trials could be used as clinical evidence to modify the medical practice and to improve the quality of perinatal care.In China, we still lack of national collaborative network and muti-center clinical database. Due to Chinese newborn population has its own race and socio-economic status, we can not copy foreign experience or conclusions directly. The establishment of national network and database will be the future direction in perinatal medicine.Medical training program for health care giver is an evidence-based, cost-effective intervention for improving perinatal care in low-income countries, particularly in rural settings. It can improve trainee’s self-confidence, knowledge and clinical skills.We conducted this study to explore the mortality, morbidity and short-term outcomes of preterm infants at different gestational age or birth weight subgroup. And we also conducted a prospective, controlled study to evaluate the effect of an educational program on learner satisfaction and knowledge in an economically disadvantaged region of Zhejiang province in China.Part one:A national survey of VLBWI in ChinaObjectives:1. To investigate the clinical characteristics, morbidity and short-term outcomes of VLBWI who admitted to tertiary NICUs.2. To compare the mortality and morbidity of VLBWI between China and developed country.Methods:1. Clinical information of all VLBWI admitted to the33tertiary NICUs was retrospectively collected during the year2010.2. The multi-center collaborative network and clinical database was established.3. The data of mortality, morbidity, short-term outcomes and medical burden was analyzed.4. Compare our data with the data from Canadian Neonatal Network (CNN) annual report of year2010.Results: 1. During the12-month study period, there were2914VLBWI admitted to the33tertiary NICUs, the mean gestational age of this cohort was30.1±2.3weeks, mean birth weight was1239.9Q181.1grams. Of all the infants,58.2%were male. Extremely low birth weight infants (ELBWI) and extremely premature infants (EPI) accounted for8.9%and25.6%respectively.2. Morbidity:Stage Ⅰ/Ⅱ ⅣH was found in25%of the VLBWI cohort, stage Ⅲ/Ⅳ IVH was accounted for9.5%. The rate of stage Ⅲ/Ⅳ ⅣH was decreased with the gestational age or birth weight increasing. Surfactant was received by39.6%VLBWI. Aminophylline was used very common. There were446infants reached the criteria for bronchopulmomary dysplasia (BPD), and7.2%was diagnosed with severe BPD. Almost half of the BPD infants treated with postnatal steroids. Hemodynamically significant patent ductus arteriosus (PDA) was diagnosed in493(18.4%) infants. To close the ductus, ibuprofen was more commonly used than indomethacin (84.9%vs.15.1%). Totally there were22infants closed the ductus by surgical ligation. Necrotizing enterocolitis (NEC) was disgnosed in194infants, which accounted for7.2%in the VLBWI who stay in hospital for more than24hours. Of all the cases,10.3%was treated with surgery. Compare to infants without NEC, it took8more days to reach full feeding in NEC group. Retinopathy of prematurity (ROP) was screened in78%infants of whom discharged after32weeks of corrected gestational age, and about a quarter of them was found any stage of ROP. Laser therapy was done in102(23.4%) cases. Culture positive hospital acquired infection (HAI) was found in346(12.8%) infants. Ventilator associated pneumonia and bloodstream infection was common HAI pattern. Gram negative bacteria accounted for61.1%, which was the most frequently organism. Gram positive bacteria and fungi accounted for24.6%and14.4%respectively.3. Outcomes and medical burden:During the hospitalization, there were187infants died,812infants withdrew medical care for some reason. Totally there were218 infants died or discharged before24hours of age. Mortality decreased with gestational age or birth weight increasing except in the subgroup of gestational age≥35weeks. For the infants who completed the treatment, the median hospital cost was33×103yuan, the mean gestational age at discharge was37.1±2.9weeks, the mean birth weight was2076.9±470.5grams. Extrauterine growth retardation accounted for two-thirds of the infants at discharge.4. Compared with the CNN data, the VLBWI admitted to our tertiary NICUs were more mature and bigger in size. ELBWI and EPI only accounted for small part. The mortality in our VLBWI cohort was higher than that in CNN data. The incidence of BPD, PDA, NEC and ROP in infants with gestational age≥29weeks or birth weight≥1000grams was also higher than that in CNN data.Conclusions:1. Compare to developed country, our VLBWI cohort was more mature and bigger in size.2. The mortality of VLBWI in China still higher than developed country.3. Medical care withdrawal was common in our VLBWI cohort.4. This is the first national survey of VLBWI in China completed with a successfully established NICU collaborative network.Part two:The multi-center epidemiologic study of late-preterm infantsObjectives:1. To explore the birth rate, delivery mode, morbidity and short-term outcomes of late-preterm infants (LPI) who admitted to NICUs in China.2. To investigate the clinical characteristics, therapeutic interventions and short-term outcomes of LPI or term infants who required respiratory support. To compare the value of different illness severity assessment tools.3. To investigate the effect and safety of surfactant when it used to treat LPI or term infants with respiratory distress syndrome (RDS).Methods:1. During the study period, clinical information of all NICU admissions in the11tertiary NICUs in Zhejiang province was retrospectively collected. The clinical characteristics of LPI were described.2. From November2008to October2009, in7tertiary NICUs, the clinical data of infants who born at≥34weeks’ gestational age, admitted at<72hours of age, requiring CPAP or mechanical ventilation for respiratory support was collected prospectively. Three different illness severity assessment tools, the Acute Care of at-Risk Newborn (ACoRN) Respiratory Score, Score for Neonatal Acute Physiology-Version II (SNAP-II) and Oxygenation index (01) were compared.3. Infants who born at≥34weeks’ gestational age and diagnosed with RDS, required mechanical ventilation, admitted to8tertiary NICUs at<72hours of age were enrolled. Surfactant was given if the infant required FiO2≥0.4to maintain PaO2≥50mmHg or SpO2>90%. Before and after surfactant, the results of blood gas, ventilator settings, and the incidence of complications were recorded and analyzed.Results:1. During the12-month study period in2007, there were44362infants born at the11hospitals, the overall preterm birth rate was8.9%, the rate of late preterm birth was6.2%. LPI had higher caesarean section rate than the whole cohort (64.9%vs58.2%). One fifth of the nursery admissions were LPI, of whom,63.8%were delivered by caesarean section. Respiratory distress (42.1%) was the most common medical problem of LPI. Hyperbilirubinemia (17.6%), hypoglycemia (8.7%) and sepsis (5.9%) were also common presentations. The first three primary diagnosis of respiratory distress included pneumonia (39.5%), TTN (22.5%) and RDS (19.0%). Compared with term infants, LPI with respiratory distress needed more respiratory support with CPAP (21.4%vs11.6%) or mechanical ventilator (15.4%vs11.0%), and also had higher in-hospital mortality (0.8%vs0.4%).2. During the study period,503newborn late preterm or term infants required respiratory support. The mean gestational age was36.8±2.2weeks, mean birth weight was2734.5±603.5grams. The majority of the neonates were male (69.4%), late-preterm (63.3%), delivered by cesarean section (74.8%), admitted in the first day of life (89.3%) and outborn (born at other hospitals,76.9%). Of the cesarean section,51.1%were performed electively. The rate of cesarean birth was significantly higher in LPI group. The common causes of respiratory distress in LPI group were RDS, TTN and pneumonia. More term infants developed severe respiratory distress (10.3%vs.5.2%), and had higher SNAP-II score (17.1±14.2vs.14.5±13.1) than LPI. Compared to the term group, the length of hospital stay was longer and the medical cost was higher in LPI group. Infants in the severe group were more mature, had the highest rate of elective cesarean section, Apgar score<7at5minutes and resuscitated with intubation, and also had the highest in-hospital mortality. The incidence of complications was increased significantly in severe group (P<0.05). The medical cost in the severe group was significantly higher than other two groups (P<0.05). ACoRN Respiratory Score was correlated with SNAP-Ⅱ (P<0.01). Higher gestational age, higher SNAP-Ⅱ score or Oxygenation index (OI), and Apgar score at5minutes<5were independent risks for death.3. There were96infants enrolled in this prospective study. The mean gestational age was36.5±2.1weeks, mean birth weight was2690.3±562.6grams. Of whom,71.9% were male,59.4%were LPI,62.5%were delivered by elective cesarean section. RDS was diagnosed at the median age of9.9hours. The first dose of surfactant was given at the median age of13.3hours with the dosage of108.5±20.2mg/kg. The second dose was given to10.4%infants. Half an hour post surfactant, PaO2/FiO2、OI、A-aDO2、 PaO2/PAO2improved significantly, and lasting to6hours. The median length of mechanical ventilation was110.5hours. The incidence of complications was28.1%. The median length of hospital stay was18.0days, median medical cost was32.9×103yuan. There was one case died due to multiple organ failure,5cases withdrew care according to parents’ decision. Compare to small dosage, the improvement of PaO2/FiO2、OI、A-aDO2、PaO2/PAO2was more significant at6hours after relatively large dose (≥100mg/kg) of surfactant, and the length of mechanical ventilation was shorter. But the length of hospital stay, medical cost, and the incidence of complications was not different between these two dosage groups.Conclusions:1. The cesarean section rate of LPI who admitted to Chinese NICUs was very high.2. Compare to term infants, more LPI admitted to NICU due to respiratory distress, hypoglycemia and intracranial hemorrhage. Respiratory distress was the most common reason for NICU admission.3. Surfactant significantly improved the oxygenation in LPI or term infants with RDS.4. The ACoRN Respiratory Score could be used as a tool to evaluate the severity of respiratory distress in newborn infants. Part three:The evaluation of an educational program for newborn stabilization in Zhejiang provinceObjectives:1. To evaluate the distribution of medical resource in the economically disadvantaged region of Zhejiang province.2. To evaluate the effect of ACoRN training program.3. To evaluate the acceptability of ACoRN teaching content and teaching material in Chinese health care giver.4. To assess the applicability of the ACoRN program to Chinese pediatric practitioners.Methods:1. Questionnaires were used to evaluate the medical resource in41level Ⅱ county hospitals in the economically disadvantaged region of Zhejiang province.2. ACoRN courses were delivered at15level Ⅱ county hospitals.3. Participants completed pre-and post-course confidence and knowledge questionnaires.4. Participants provided feedback through post-course focus group discussion.Results:1. A total of216physicians and nurses participated in this training program.2. Participants’ total confidence score increased from47.6±10.4to59.2±7.7after the training (effct size d=1.28).3. The knowledge evaluation indicated that the total knowledge score increased from31.5±5.1to34.7±3.5(effect size d=0.77). Knowledge score for each individual scenario except scenario D increased significantly. 4. The participants rated the utility and function of the program highly with a range from4.2to4.6. The ACoRN primary survey and the systemic framwork sequences were well accepted.Conclusions:1. Confidence relating to neonatal stabilization improved significantly following the ACoRN program.2. ACoRN program appears to be well received by Chinese health care professionals.3. ACoRN program can be applied in other region of China after structured and systematic evaluation.
Keywords/Search Tags:very low birth weight infant, late-preterm infant, elective cesarean section, respiratory distress syndrome, mortality, morbidity, training, evaluation
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