Although a WHO definition of neonatal mortality is well accepted worldwide, there is currently no established and detailed definition to be used in immunization trials and maternal surveillance following the widespread introduction of maternal immunizations. This is a missed opportunity, as comparability of data across studies or monitoring systems would facilitate interpretation of the data and promote scientific understanding of the event. Safety surveillance of currently approved vaccines has focused on fetal death, pregnancy outcome (live birth or stillbirth), birth defects, and infant growth and development . More than 40% of all deaths in children under 5 occur during the neonatal period: the first month of life. Vaccination of pregnant women has been shown to benefit both mother and child by reducing morbidity and mortality. With an increasing number of vaccination studies conducted in pregnant women, as well as the introduction of vaccines recommended for pregnant women, there is a need to clarify the details of neonatal mortality. This manuscript defines the degree of certainty of neonatal death, related to the viability of the newborn who confirmed the death and the time of death during the neonatal period and in relation to maternal vaccination. Of the 1204 newborns (59.9% boys and 40.1% girls) admitted in 2016, 79 died (65.6/1000 live births). The main causes of admission were sepsis (35.5%), respiratory distress syndrome (15.4%) and perinatal asphyxia (10%). The leading causes of death were respiratory distress syndrome (48.1%); extremely low birth weight (40.9%) and very low birth weight (30.5%).
After adjustment, low birth weight (adjusted odds ratio (ARR) = 4.55, 95% CI 1.97 to 10.50), very low birth weight (OR = 19.24, 95% CI 5.80 to 63.78), late intake (24 h after diagnosis) (OR = 2.96, 95% CI 1.34 to 6.52), Apgar score (1 min AOR = 2.28, 95% CI, 1.09-4.76, 5 min AOR = 2.07, 95% CI 1.02-4.22) and congenital anomalies (AOR = 3.95, 95% CI 1.59-9.85) were significantly associated with neonatal mortality. Infants who remained in the specialized neonatal unit > 24 hours (OR = 0.23, 95% CI 0.11-0.46) had a lower probability of death. Overall, 95.8 per cent of mothers of newborns participated in antenatal care and 96.6 per cent gave birth in institutions. None of the maternal conditions were associated with neonatal mortality in this study. The classification of a child`s life into well-defined periods has become an important standardization for determining the care and interventions needed to increase children`s chances of survival. The neonatal period, which is considered worldwide to begin at birth and end at 28 full days of life , is considered the most vulnerable period of an infant`s life. Neonatal mortality has been defined by the World Health Organization (WHO) as “deaths due to live births during the first full 28 days of life” , which can be subdivided into early neonatal deaths (deaths between 0 and 7 full days of birth) and late neonatal deaths (deaths after 7 days to 28 full days of birth) . Neonatal deaths as a side effect following maternal vaccination were often not monitored. Outcomes such as preterm birth, fetal death and stillbirth were the priority events in most maternal vaccine clinical trials.
In studies measuring neonatal mortality, very few provided a referenced case definition. Saleem M, Iqbal R. Shahzad Bokhari, et al. Patterns of neonatal admissions and their outcome in a tertiary care hospital in southern Punjab (a 5-year study). P J M H P. 2014;8:916–21. SNCU was founded in 2003 in collaboration with the University Hospital of Orotta, the Paediatric Association and the Ministry of Health. with the support of the Hummer Forum, a non-governmental organization based in Germany. Later in 2013, additional neonatal units were established in four regional referral hospitals across the country. A definition designed as an appropriate tool to describe relationships requires identification of the endpoint (e.g., neonatal death) independently of exposure (e.g., vaccinations). Therefore, in order to avoid selection bias, a restrictive time interval between vaccination and neonatal death is not an integral part of such a definition.
Rather, to the extent possible, the details of this interval should be assessed and reported as described in the data collection guidelines. Newborn deaths are due to poor maternal health, inadequate nutritional status [16,17,18] or care during pregnancy [9, 10, 14, 35]. Although no association with maternal age, antenatal care, severity and obstetric complications similar to other studies has been identified , the high prevalence of neonatal mortality attributed to LBW may be indicative of poor maternal conditions [9, 10]. The results of this single SNCU study highlight the need for early identification and appropriate risk management to reduce neonatal mortality and achieve the Sustainable Development Goals [2, 12, 27]. As with all Brighton Collaboration case definitions and guidelines, a regular review of the definition and its guidelines is planned, which will be reviewed regularly (i.e. every three to five years) or more frequently as required. Sands Australia provides information and support to anyone who has experienced a stillbirth or newborn death. You can speak to someone 24 hours a day on their helpline, 1300 072 637. Apgar`s score was > 7 for 61.2% and 79.8%, respectively, in the first 1 and 5 minutes, respectively. A significant inverse association was observed between the Apgar score and neonatal mortality (P < 0.001) (Table 3). Data were collected from four sources: newborn admission (logbook), patient card, discharge form and death registry.
All information correctly labeled by a neonatal specialist in the ICD-10 registry was extracted using a structured checklist [11, 28]. Information on initial diagnosis of admission (sepsis, IBS, perinatal asphyxia), gestational age (>=/< 37 weeks) and height for gestational age (AGA), small for gestational age (GAS) and large for gestational age (LGA), type of delivery (spontaneous vaginal delivery (SVD)/caesarean section), place of birth (gynecological-obstetrics (GynObs), other institution / home), diagnosis at time of admission ( = 1 h), birth weight (normal birth weight (NBW), high birth weight (HBW), low birth weight (LBW) and very low birth weight (VLBW)), birth defect (yes/no), Apgar scores (recorded by the doctor or general practitioner at the place of delivery), maternal age (years), obstetric complications (eclampsia/preeclampsia, diabetes mellitus), antenatal visits, pregnancy and neonatal death (yes/no). These guidelines represent an ideal standard for the collection of post-immunization data from pregnant women to allow comparability of data and are recommended to complement the data collected for the specific study question and attitude. It is recognized that not all data elements can be collected or may be required. The guidelines are not intended to direct primary reporting of neonatal deaths to a surveillance system or study monitor. Researchers developing a data collection tool based on these data collection guidelines should also refer to the case definition criteria that are not repeated in these guidelines. While neonatal mortality has declined globally and in all regions, it has declined more slowly than mortality among children aged 1-11 months or 1-4 years. Globally, the average annual rate of reduction in the neonatal mortality rate from 1990 to 2020 was 2.6%, a reduction of less than 3.6% for children aged 1 to 59 months. As a result, the proportion of neonatal deaths in all under-five deaths increased from 40% in 1990 to 47% in 2020. In all regions, the annual rate of reduction from 1990 to 2020 was higher for children aged 1 to 59 months than for newborns. Preterm birth and low birth weight cause about 1 in 4 neonatal deaths. Premature babies can develop life-threatening complications such as breathing problems, brain hemorrhage, infections, and bowel problems (necrotizing enterocolitis).
8An event does not meet the case definition if the examination results in a negative result of a criterion (necessary condition) necessary for diagnosis (for example, no live birth). Such an event should be rejected and classified as “No cases of neonatal deaths”. Data from vital registration and vital statistics systems, health management information systems in 80 countries, and specific national surveillance systems (Mozambique and South Africa) do not show a significant deviation from the projected mortality for this age group for 2020 and, in some cases, fewer deaths than expected based on historical data. As more data arrives from countries and more analysis is done, these results could change for 2021. Deaths that occur within the first 24 hours (<24 hours) or the first day of life must be recorded in units of minutes or hours of life completed. Deaths occurring ≥24 hours of life should be recorded in days from day 1 to 27 full days (International Statistical Classification of Diseases and Related Health Problems – 10th Revision, ICD-10) . It is important to note that the first day of life does not correspond to the age of 1 day. A newborn is only 1 day old if it has survived more than 24 hours of life.