Abstract
BackgroundThe death of a child before or shortly after birth is frequently preceded by an end-of-life decision (ELD). Population-based studies of incidence and characteristics of ELDs in neonates and infants are rare, and those in the foetal-infantile period (> 22 weeks of gestation – 1 year) including both neonates and stillborns, are non-existent. However, important information is missed when decisions made before birth are overlooked. Our study protocol addresses this knowledge gap.MethodsFirst, a new and encompassing framework was constructed to conceptualise ELDs in the foetal-infantile period. Next, a population mortality follow-back survey in Flanders (Belgium) was set up with physicians who certified all death certificates of stillbirths from 22 weeks of gestation onwards, and infants under the age of a year. Two largely similar questionnaires (stillbirths and neonates) were developed, pilot tested and validated, both including questions on ELDs and their preceding decision-making processes. Each death requires a postal questionnaire to be sent to the certifying physician. Anonymity of the child, parents and physician is ensured by a rigorous mailing procedure involving a lawyer as intermediary between death certificate authorities, physicians and researchers. Approval by medical societies, ethics and privacy commissions has been obtained.DiscussionThis research protocol is the first to study ELDs over the entire foetal-infantile period on a population level. Based on representative samples of deaths and stillbirths and applying a trustworthy anonymity procedure, the research protocol can be used in other countries, irrespective of legal frameworks around perinatal end-of-life decision-making.
Highlights
The death of a child before or shortly after birth is frequently preceded by an end-of-life decision (ELD)
Stillborns and deceased neonates cannot be seen as separate patient populations, since they are in essence the same patient where an ELD can be made either before or after birth
The study design involves the development of a validated conceptual framework of ELDs spanning the entire foetal-infantile period and the development of a survey methodology that addresses the particular difficulties in capturing and surveying stillbirths and neonatal deaths, and provides opportunities for comparison of ELD practices between hospitals
Summary
This population study has the design of a mortality follow-back survey based on all death certificates of stillbirths and neonates. NTD: non-treatment decisions, APS: alleviation of pain and/or symptoms, LI: lethal interventions This table only includes medical interventions to the child or foetus represented all eight Flemish NICUs, researchers in the field of end-of-life care and an ethicist. For ELDs in stillborns a new questionnaire was developed based on previously validated questionnaires on TOP after 22 weeks [11, 12], questionnaires on ELDs in minors and neonates [14, 16, 26], and the newly developed framework for end-of-life practices in the foetal-infantile period. For each stillbirth for which a questionnaire is completed, the physician is asked to fill out a death certificate This makes it possible for the lawyer to link the answers in the questionnaire to the clinical and demographic characteristics of the stillborn child (for a schematic overview of this procedure, see Fig. 2). Physicians will be able to ask Stillbirth in one of the 10 selected hospitals
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