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Abstract
Background The standardised management of neonatal critical care centres can help improve health outcomes of vulnerable newborns. Guidance is required to update evidence related to construction and management of neonatal critical care centres in China.
Objective To establish expert consensus on the essential capability lists for neonatal critical care at three levels in China.
Design and setting According to China’s administrative divisions, the Chinese guidelines stratifies neonatal critical care into three levels: county level (basic and special care), city level (intensive care) and province level (comprehensive care including neonatal surgery and more subspecialty interventions). A modified Delphi study was conducted. A group of 20 neonatologists from the Chinese Association of Neonatologists rated the importance of capability items on a 5-point Likert scale.
Results At county level, the list consisted of 29 items related to basic and special care, and 3 items were unanimously rated very important by all experts: neonatal resuscitation, endotracheal intubation and continuous positive airway pressure ≥72 hours. At city level, group consensus defined 38 items as essential. Besides the essential items of county level, more items for intensive care were included in city level. At province level, 64 items reached consensus, including neonatal surgery and more advanced subspecialty interventions. The Kendall’s W values showed good agreement among experts in both rounds, and an increase from round 1 to round 2.
Conclusions We developed the capability lists for neonatal critical care at three levels in China. Neonatal resuscitation should be provided by all levels. Interventions for preterm newborns are stratified according to gestational age and birth weight. Congenital abnormalities requiring surgical services need to be managed in high-level centres.
- neonatology
- health services research
Data availability statement
Data are available on reasonable request. The data that underlie the results reported in this article, after de-identification, will be made available following publication to researchers who provide a methodologically sound proposal. Data requestors need to email to the corresponding author, and to sign a data access agreement.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
A tiered provision of neonatal care is proven to be effective in preventing neonatal mortality and disability, which has been implemented in some countries and regions.
Delphi method has been widely used and accepted in the field of healthcare.
No relevant Delphi studies on the essential capabilities for different levels of neonatal care were identified through our literature search.
WHAT THIS STUDY ADDS
We have established expert consensus on the essential capabilities for neonatal critical care, and discussed evidence-based practices for the improvement of neonatal outcomes.
This study presents detailed lists of capabilities in Chinese guidelines, and compares the similarities and differences of the guidelines and standards previously published.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
We are developing quality indicators based on the results, which will provide a resource for policy-makers, healthcare providers and health service planners to plan and deliver neonatal health services, and thus improve outcomes of vulnerable newborns.
Introduction
To achieve the sustainable development goal to end preventable newborn deaths by 2030, countries need to expand provision of care to reach all newborns to ensure that every newborn has the chance to live a healthy and productive life.1–3 In 2021, approximately 2.3 million newborns died globally.4 In addition, many small and sick newborns survive with a long-term disability. Most disabilities among newborns are preventable with quality maternal and neonatal care.
In China, the neonatal mortality rate decreased from 33.1% in 1991 to 3.1% in 2021.5 6 In January 2016, China began implementing the ‘Comprehensive Two-Child Policy’. The numbers of pregnant women with advanced maternal age and newborns at high-risk both increased.7 UNICEF and China’s National Health Commission had jointly carried out ‘Maternal and Child Health Cooperation Programme’ from 2016 to 2020 in China. Guidelines for Construction and Management of Neonatal Critical Care Centres were published on 8 December 2017.8 The guidelines standardise the capabilities of neonatal care systems at different levels, and guide local health departments to organise neonatal care networks. During the implementation of the guidelines, we have received feedback from facilities and local health departments all over the country. In order to update the guidelines, we conducted the Delphi study to establish expert consensus on the essential capability lists for neonatal critical care at three levels.
Methods
Study design
A modified Delphi method was conducted, which has been widely used and accepted in the field of healthcare.9–13 We first convened an expert panel and followed a two-round modified Delphi process with experts answering questionnaires to rate importance of capability items.
Participants
The majority of Delphi studies have used between 11 and 50 respondents.11–13 A group of 20 professional neonatologists who were members of the Chinese Association of Neonatologists were recruited. Experts were required to have professional experience for at least 15 years, and have an academic rank of associate professor or above. Geographical spread was also taken into account.
Questionnaire preparation
It is an acceptable and common modification of the Delphi process to use a structured questionnaire that is based on basic information and/or literature review.9–14 PubMed search was conducted on 18 October 2020, using the search terms ‘neonatal care’ and ‘level’. After reading the titles and abstracts, we identified 30 articles published in English which mentioned levels of neonatal care in different countries and regions, and then reviewed the full texts and references. We subsequently searched the websites of WHO, UNICEF, American Academy of Pediatrics (AAP) and British Association of Perinatal Medicine (BAPM) for more evidence-based practices in newborn health. A preliminary set of questionnaires were identified through the Chinese guidelines8 and the articles were reviewed.3 15–17
In this study, a ‘newborn’ refers to an infant in the first 28 days after birth; ‘preterm’ refers to delivery at <37 weeks of gestation. The Chinese guidelines define a neonatal critical care centre as a facility or unit constructed in a hospital with a neonatal ward or a neonatal intensive care unit, providing 24-hour inpatient care for newborns, and undertaking referral, consultation, training and mentoring within a regionalised system.
According to China’s administrative divisions, the Chinese guidelines stratifies neonatal critical care into county, city and province level. In practice, the hospital levels of neonatal critical care should take into account local factors such as geographic regions, regional population size and need, regional organisation of healthcare services and the functional capabilities of hospitals that provide inpatient care for newborns. County-level centres provide basic and special care (eg, newborns born ≥32 weeks’ gestation or weighing ≥1500 g, and those with moderate illness); city-level centres provide intensive care (eg, newborns born ≥28 weeks’ gestation or weighing ≥1000 g, and those with critical illness) and province-level centres provide comprehensive care (eg, newborns born <28 weeks’ gestation or weighing <1000 g, and those requiring neonatal surgery or medical subspecialty interventions).
Three questionnaires were compiled in Chinese language, each for a different level. All the capabilities were categorised into four domains: clinical techniques, laboratory and imaging tests, management measures for inpatient newborns and neonatal surgery.
Delphi process
The experts were asked by email to rate the importance of each item on a 5-point Likert scale (1=very unimportant; 2=unimportant; 3=neutral; 4=important and 5=very important).10 12 14 18 They could give responses and provide other items not listed previously.11 12 Each expert completed the questionnaires independently from 28 October to 4 November 2020.
The mean score with SD of ratings for each item, and the percentage of experts rating 4 or 5 were calculated. If ≥75% of the experts rated an item as 4 or 5 and the mean Likert score was ≥4, the item was considered to have reached consensus to be included.9–13 18 Items which did not fulfil the criterion were excluded or revised after discussion. However, when some certain items believed to be important fell just below the threshold for inclusion, the authors could consider including these items as posteriori considerations if sufficient justification was provided.13 Additional items proposed by experts were included as new items after discussion.
The new questionnaires were brought forward to round 2 with specific feedback. The experts were requested by email to rate the importance of the items of the newly refined lists from 26 November to 3 December 2020. The result regarding a certain item could be retained or adjusted by individual experts based on their review and assessment of the feedback of round 1.9–13 Items were either included or rejected based on the results of round 2.
Statistical analysis
The quantitative data were analysed using descriptive statistics (Microsoft Excel, V.2010). The interexpert agreement was computed with Kendall coefficient of concordance (Kendall’s W), and the calculations were performed with IBM SPSS Statistics V.22. The Kendall’s W refers to the extent of group response agreement among experts across all items, ranging from 0 (no agreement) to 1 (complete agreement). Kendall’s W value was tested by χ2 test, and p values <0.05 were considered to be statistically significant.14 18 19
Results
Experts
The demographic information and professional characteristics of experts is presented in table 1. All the 20 experts responded to the study and completed both rounds. They were from 16 provinces, autonomous regions and municipalities of China. The mean (SD) age was 53.5 (4.8) years.
Demographic information of the experts (n=20)
County-level capabilities
The items with the importance scores of county level are presented in table 2. The final list consisted of 29 items related to basic and special care of county-level centres. Three items were unanimously rated very important by all experts in both rounds: neonatal resuscitation, endotracheal intubation and continuous positive airway pressure (CPAP) ≥72 hours.
Capability list for neonatal critical care centre of county level and the importance scores
In round 1, ‘chest drainage’ was assessed as important or very important by 70.0% (14/20) of the experts. We proposed changing the ‘chest drainage’ to ‘thoracocentesis and/or chest drainage’ based on experts’ comments. In round 2, 19 of 20 experts (95.0%) rated it as important or very important. At last, ‘thoracocentesis and/or chest drainage’ was included in the final list.
According to comments during round 1, five additional items were included in round 2: lumbar puncture, abdominocentesis, bone marrow aspiration, enteral nutrition and 24-hour blood gas analysis. In round 2, ‘bone marrow aspiration’ had low agreement on importance (55.0%, 11/20) with mean (SD) score of 3.55 (0.51), and consequently was removed from the final list of county level. The other four items met the inclusion criteria and were included.
In round 1, the mean (SD) score of ‘24-hour neonatal transport service’ was 3.65 (0.49) with 65.0% (13/20) agreement on its importance, which was lower than the inclusion criteria. The item was carried forward to round 2 for further discussion. The result of mean and percentage of importance remained unchanged in round 2. The scores and comments of the experts were reviewed, resulting in ‘neutral’ rated by 7 experts and ‘important’ rated by 13 experts. The experts who rated ‘neutral’ expressed concern that it would be difficult to perform this service in some counties. Considering regional disparity in services offered, ‘24-hour neonatal transport service’ was expected to be strengthened, particularly at county level in rural areas. This item was still retained in the final list of county level.
City-level capabilities
Table 3 shows the results of the city-level items. Group consensus defined 38 items as essential. Besides the essential items of county level, more items for intensive care were included in city level. In round 1, no items were eliminated. We included five additional items in round 2 (lumbar puncture, abdominocentesis, bone marrow aspiration, enteral nutrition and 24-hour blood gas analysis), which all reached consensus. After round 1, three items were revised based on experts’ comments, and the restated items (thoracocentesis and/or chest drainage, peripherally inserted central catheters and blood transfusion) were evaluated as better than the original items.
Capability list for neonatal critical care centre of city level and the importance scores
Province-level capabilities
Importance scores of province-level items are presented in table 4. 64 items reached consensus and included more advanced subspecialty interventions. In round 1, no items were eliminated. Six items (lumbar puncture, abdominocentesis, bone marrow aspiration, enteral nutrition, 24-hour blood gas analysis and surgery for neonatal hydrocephalus) were added in round 2, and all reached consensus to be included. Four items were revised after round 1. At last, three items were accepted based on the descriptions of round 2 (thoracocentesis and/or chest drainage, peripherally inserted central catheters and blood transfusion), whereas ‘gastroscope’ was retained as the description of round 1.
Capability list for neonatal critical care centre of province level and the importance scores
Kendall coefficient of concordance
The Kendall’s W value are presented in table 5. The results showed good agreement among experts in both rounds, and an increase from round 1 to round 2 (0.590–0.661 at county level, 0.634–0.683 at city level and 0.612–0.622 at province level).
Interexpert agreement (Kendall’s W) of the two rounds
Discussion
As countries expand health systems towards achieving universal health coverage, both access to care and quality of care will be important to ending preventable newborn deaths by 2030.20 Supporting healthy development during early childhood is the best investment a country and society can make in the future generation.21 High-quality care requires an integrated health system and multidisciplinary teams from all levels working in a coordinated and facilitative manner to ensure equitable provision of effective services.22 A neonatal critical care centre is part of an integrated network with clear referral pathways and should be designated according to a standardised level of care. Special and intensive care is centralised in hospitals of designated levels.23
WHO indicates that inpatient interventions are proven to be effective in preventing neonatal mortality and disability, according to different health system levels. Special and intensive care is required based on well-established obstetric care and basic neonatal care. Vulnerable newborns require high-quality inpatient care delivered by professional providers in dedicated health facilities. Newborns may have different needs depending on their fragility. When small and sick newborns require intensive care, they should be managed in a higher-level hospital. WHO defines neonatal care as three levels with different types of care: primary level providing essential newborn care; secondary level providing special newborn care and tertiary level providing intensive newborn care.3
AAP updated policy statement for a tiered provision of care in 2012, and reaffirmed the need for uniform and nationally applicable definitions, and consistent standards of service for public health to improve neonatal outcomes. AAP classifies neonatal care into four levels, and defines the capabilities of each level: level I (well newborn nursery) providing basic care; level II (special care nursery) providing specialty care; level III (neonatal intensive care units (NICUs)) providing subspecialty intensive care and also ideally maternal-fetal medicine and level IV (regional NICU) providing care for the most complex and critically ill newborns, and surgical repair of complex conditions.16
In the 2010 edition of Service Standards for Hospitals Providing Neonatal Care published by BAPM, managed clinical networks are recommended as the best approach to service delivery for neonatal care. The BAPM standards describe networks as being comprising three types of unit: special care units (SCU) providing special care; local neonatal units (LNU) providing special care, high dependency care and a restricted volume of intensive care (as agreed locally) and NICUs providing the whole range of medical (and sometimes surgical) neonatal care for their local population.17
These guidelines and standards all recommend a tiered provision of neonatal care. We compared the similarities and differences of them. Basic care is provided at county level of Chinese guidelines, primary level of WHO standards and level I of AAP statement. Special care is provided at county level of Chinese guidelines, secondary level of WHO standards, level II of AAP statement and SCUs of BAPM standards. In BAPM standards, LNUs provide special care, high dependency care and a restricted volume of intensive care. Neonatal intensive care and paediatric surgery are provided by high-level centres or units, such as tertiary level of WHO standards, level III/IV of AAP statement and NICUs of BAPM standards. Level IV of AAP statement is expected to manage the most complex conditions. In Chinese guidelines, intensive care is provided at city level and province level, but paediatric surgery and some advanced subspecialty techniques are provided at province level. Furthermore, Chinese guidelines suggest that newborns born <28 weeks’ gestation or weighing <1000 g are expected to be managed in province-level centres.
Globally, the leading causes of neonatal deaths were preterm birth complications (36.1%), intrapartum-related events (23.9%) and congenital abnormalities (9.7%) in 2019.24 In China, the leading causes were preterm birth (27.3%), intrapartum complications (21.7%) and congenital malformations (20.2%) in 2018.25
Preterm birth
Preterm birth had been the leading cause of under-5 deaths in China continually from 2009 to 2018.25 26 Newborns who are born too soon, too small or acutely ill are at greatest risk of death or developmental delays, physical disabilities and poor neurodevelopmental functioning.27 AAP suggests that very low birth weight and/or very preterm infants should be delivered in a level III facility.16 In BAPM’s opinion, newborns delivered at <27 weeks of gestational age require complex and long-term intensive care, and should be transferred to the nearest NICU.23
In this study, neonatal care is stratified by gestational age and birth weight. County-level centres should provide CPAP ≥72 hours and conventional ventilation ≥24 hours; city-level and province-level centres should provide these two techniques routinely and continuously and province-level centres are expected to perform high-frequency ventilation. Preterm infants need to be assessed for pulmonary surfactant deficiency, and surfactant replacement therapy should be administered appropriately at all three levels.
Intrapartum complications
Most of the neonatal deaths caused by intrapartum-related events can be prevented with low-cost interventions.28 Neonatal resuscitation can largely reduce deaths related to neonatal asphyxia.29 In China, ‘Neonatal Resuscitation Programme’ which was implemented from 2004 to 2021 has trained a competent workforce to ensure that at least one attendant skilled in neonatal resuscitation is at the site of every delivery.30 The mortality due to neonatal asphyxia remarkably decreased from 0.76% in 2003 to 0.19% in 2020.29 In our study, neonatal resuscitation is one of the most important techniques of neonatal critical care at all levels. Neonatal resuscitation and endotracheal intubation were unanimously rated ‘very important’ by all experts in both rounds.
Congenital abnormalities
Newborns with congenital abnormalities may require immediate surgical interventions, and some conditions may require access to genetic services. WHO recommends that all newborns need to be assessed for congenital abnormalities, managed appropriately and referred in time. Paediatric surgery and genetic services are required in tertiary-level hospitals which provide neonatal intensive care.3 AAP suggests that major surgery should be performed by level III units, and that level IV units should have the capability for surgery of complex conditions.16 Paediatric surgical specialists and anaesthesiologists with paediatric expertise are recommended to perform neonatal surgery.31 BAPM indicates that newborns requiring surgical care should receive the same level of care, support and specialist expertise in a medical neonatal unit.17
In our lists, a county-level centre has the responsibility to provide medical care for physiologically stable term newborns with mild abnormalities, and to stabilise newborns with critical illness until transfer to a higher-level centre. Neonatal surgery is recommended to be performed in a province-level centre. The hospitals should be equipped with appropriate laboratory and diagnostic tests for managing congenital abnormalities at a standardised level.
Neonatal transport
Specialist neonatal transport services can provide safe and efficient transfer by experienced teams equipped with special transport vehicles. Health provision varies in different areas due to geographic, economic, cultural and demographic disparities. In China, the neonatal mortality rate in urban areas was lower than that in rural areas every year during 1991–2021.6 The distribution of cause-specific deaths was significantly different between rural and urban areas.25 In China, antenatal care and hospital delivery services have achieved universal coverage.5 However, when newborns suffer critical conditions after discharge, but cannot be managed effectively with available resources, particularly in rural areas, they should be transported appropriately and timely.32
Limitations
There were multiple challenges to developing networking. First, the Chinese guidelines include a variety of measures, but we did not discuss all of them in this manuscript (eg, regional organisation, beds arrangement of hospitals, physical environment, hygiene infrastructures and equipment, human resources, data and information systems, quality control, infection prevention and control, support for breast feeding, developmental supportive care, collaboration of maternal and neonatal care, in utero transport and maternal-fetal medicine). Second, only literature published in the English language was reviewed. In addition, future studies on the current state of neonatal critical care centres in China relative to the criteria developed with input of experts are needed.
Conclusion
We have developed the essential capability lists for neonatal critical care at three levels in China. Neonatal resuscitation should be provided by all levels. Interventions for preterm newborns are stratified according to gestational age and birth weight. Congenital abnormalities requiring surgical services need to be managed in high-level centres. The results will provide a resource for policy-makers, healthcare providers and health service planners to plan and deliver neonatal health services.
Data availability statement
Data are available on reasonable request. The data that underlie the results reported in this article, after de-identification, will be made available following publication to researchers who provide a methodologically sound proposal. Data requestors need to email to the corresponding author, and to sign a data access agreement.
Ethics statements
Patient consent for publication
Ethics approval
Not applicable.
Acknowledgments
We would like to acknowledge all the experts who have given their time and invaluable experiences to make this study possible.
Footnotes
XL, LL and QL contributed equally.
Contributors ZF, XL and XK had full access to all the data in the study and take responsibility for the entire work, from idea to complete manuscript. Concept and design: ZF, XL, XK, LL and QL. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: XL, LL and QL. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: LZ, XL, LL, QL and XK. Obtained funding: ZF. Administrative, technical or material support: ZF, YZ, PL, QZ, SZ and TL. Supervision: ZF, XK, XL, LL and QL. Approval of the final version of the manuscript: all authors.
Funding This work was supported by National Key R&D Programme of China (grant number 2021YFC2701702) and UNICEF (grant number 501MCH).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.