The condition of the infants in the case cannot be described as "stable" when an infant under 32 weeks gestation is classified as very premature.

Dr Evans and Dr Bohin provide misrepresentations of the very vulnerable health status of premature neonates and totally overlook findings that reveal the precariousness of neonatal prematurity.  Most of the infants in the case are classified as very preterm infants, defined as being born after less than 32 weeks gestation. In addition to this, many of the infants would be classed as having a very low birth weight, which is defined as weighing under 1500g. The first three of four infants who died between June 2015 - August 2015 were all very preterm and on the margins of very low birth weight. These two characteristics alone place the infants at significant risk of mortality.    The expert witnesses made no effort to present a genuine picture of a comparable neonatal unit, and it simply cannot be taken as a norm that not a single expert witness was a neonatologist. The physiological properties of a preterm neonate are vastly different from a term neonate; so great caution should be taken by any expert whose credentials are limited to paediatric medicine when what they are dealing with is the comparatively rare preterm infant. One recent study analysed the common causes of hospital mortality in a regional preterm population admitted to a neonatal intensive care unit. The study period ran from 2007 to 2011 and included 4454 neonates admitted directly from the maternity ward. Of those admissions, 345 (7.7%) died. This is a higher incidence than the mortality rate at CoCH, yet there was no murder investigation conducted into the deaths of these neonates (Schindler et al. 2017).

Common causes of death on a NICU

The most common cause of death across all gestational groups was major IVH (cause-specific mortality rate [CMR] 22 per 1000 infants), followed by acute respiratory illnesses [ARI] (CMR 21 per 1000 infants) and sepsis (CMR 12 per 1000 infants).  The mortality rate differed based on gestational age, with IVH deaths occurring among the more premature infants.  The authors concluded that perinatal factors have a significant impact on cause-specific mortality and suggested that the varying timing of death provided an insight into the manner by which premature neonates exhibit prolonged vulnerability to disease.  Neonatal factors associated with increased mortality were early onset sepsis, persistent pulmonary hypertension, pulmonary haemorrhage, major IVH, moderate-severe hypoxic ischaemic encephalopathy and NEC.  The overall survival curve showed that 80% of infants who die do so within the first three weeks of life, and 90% die within the first five weeks.  None of this information was presented as relevant to the deaths in this case.

Deaths due to acute respiratory illness

22% of deaths were twins

Death from acute respiratory problems include hyaline membrane disease, pulmonary hypertension, pulmonary haemorrhage and pulmonary hypoplasia. Deaths attributable to chronic lung disease were not included in this group.

Deaths due to sepsis

26% of deaths were twins

Deaths attributed to either early or late onset sepsis. These include deaths that occur in either the acute or subacute phase of illness. For example, an infant that progressed to subsequent organ failure as a result of sepsis would be classified as a death due to sepsis. These deaths were not differentiated by causative organism.

Deaths due to IVH

19% of deaths were twins

Any death attributable to Grade 3 or higher intraventricular and/or intracerebral haemorrhage. This includes deaths following redirection of care following a major haemorrhage.

Common patterns and trends in sudden unexpected neonatal collapse

The following relates to a study attempting to identify antecedents to a diagnosis of cerebral palsy by retrospectively analysing 1182 records from the no‐fault Japan Obstetric Compensation System for Cerebral Palsy database.  The group identified 45 patients (3.8%) who were subsequently diagnosed with severe cerebral palsy due to sudden unexpected postnatal collapse (SUPC). All the patients were healthy at birth, based on the criteria of five‐minute Apgar scores of seven or more, with normal umbilical cord blood gases and no need for neonatal resuscitation within five minutes of birth (Miyazawa et al., 2019).  A particularly interesting finding was that of the 45 patients, 10 developed sudden unexpected postnatal collapse during early skin‐to‐skin contact (SSC). Medical personnel were not present in all 10 cases: nine were being breastfed at the time and eight of the mothers did not notice their infant's abnormal condition until medical staff alerted them.  This finding is relevant as the testimony given by the parents in this case is treated with particular sensitivity, owing to the traumatic circumstances of the case.  However, such an approach may result in a failure to appropriately identify antecedents to later collapses.  Similar to the case at CoCH, a higher proportion of the infants were male (57.8%), and issues with resuscitation were prevalent.  Resuscitation was initiated within two hours of birth in 11 (24.4%) infants and within 24 hours of birth in 31 (68.9%) infants.  More relevant to the case at CoCH, though, was the finding that of the ten infants that suddenly collapsed during skin-to-skin contact, eight developed SUPC during the night-time or in the early morning shift.  In nearly every instance, the infants were being breastfed at the same time.  This correlation between night-time feeding and collapse is not unique, as ~85% of SUPC occurs during the night-time hours and subsequent to the infant being fed (Blair et al., 2006).  

Immaturity of the brain stem plays a primary role in SUPC, and this is especially relevant for preterm neonates

Premature infants, especially those born very early or with complications, may experience various issues with brainstem function. The brainstem is a critical part of the central nervous system that controls many essential functions of the body. Here are some potential issues that premature infants may face relating to brainstem function: Apnoea of prematurity: Premature infants often exhibit episodes of apnoea, which is the temporary cessation of breathing. These apnoea episodes occur due to the immaturity of the brainstem's respiratory centres, which regulate breathing. Infants may require monitoring and sometimes even respiratory support until their brainstem function matures. Bradycardia: Premature infants may experience bradycardia, a condition characterised by a slow heart rate. This can occur due to immaturity in the brainstem's cardiac regulatory centres, which control heart rate and rhythm. Monitoring and intervention may be necessary to ensure adequate cardiac function. Feeding difficulties: The brainstem plays a role in coordinating suck-swallow-breathe patterns during feeding. Premature infants may have difficulties coordinating these actions, leading to feeding challenges. They may require specialised feeding techniques or even feeding assistance until their brainstem matures. Temperature regulation: The brainstem helps to regulate body temperature by controlling blood flow and activating mechanisms like shivering or sweating. Premature infants may have limited temperature regulation capabilities due to an immature brainstem. They are susceptible to hypothermia or hyperthermia and need careful monitoring and environmental support to maintain a stable body temperature.

Apnoea analysis in preterm neonates

In the largest study recording desaturations and bradycardia in preterm neonates, Vergales et al., found that: “During the 747 days for which we had electronic alarm data, there were 8,190,418 alarms. On average, there was a daily census of 37.8 infants cared for by 17 nurses per shift. Thus, there were 27 alarms per nurse per hour, or an alarm approximately every 2.2 minutes per nurse.” Further, they demonstrated that the number of events reported by nurses was considerably lower than the events detected by their algorithm, suggesting a significant issue with under-reporting desaturations associated with apnoea.  

Desaturations abound

The study involved 298 very low birth weight (<1.5 kg) infants over a period of 771 days. Researchers found that reporting by nurses was unreliable. They found “two kinds of discrepancy between nursing records and algorithm-detected events. First, nurses reported many events that the algorithm did not verify, and second, the algorithm detected many events that were not documented in the nursing record.” They speculated that: “significant underreporting of events can be ascribed both to desensitisation because of false alarms, as well as to distrust because of failure of the monitors to detect serious events.” This data demonstrates that apnoea, bradycardia and desaturations are common occurrences on neonatal units.  It is impossible for Dr Evans to retrospectively identify which desaturations have clinical relevance given the apparent frequency of such events in the preterm neonatal population.

Withdrawal of treatment as a major cause of death in a neonatal unit

A retrospective analysis was performed during a 10-year period to determine the major cause of death for infants in a neonatal unit.  The study found that 61.6% of infant deaths followed withdrawal of therapy, 20.8% followed withholding of therapy and 17.6% died despite attempted CPR. Within the treatment-withdrawal group, approximately equal numbers of infants were considered unstable vs stable at the time of death (52.2% vs 47.8%) (Weiner et al., 2011) .  These findings should be considered when evaluating possible causes of death.  In the UK, there is no policy surrounding end of life care for very premature neonates.  However, there are three clear instances where the cause of death was due to the withdrawal of treatment. These cases include Child C, Child D, and Child I.  Child C was resuscitated, developed a heart rhythm and spontaneous breathing and Dr Gibbs instructed the parents that the child would be brain damaged and prescribed intravenous morphine, which would have terminated his life.  For Child D and Child I, both infants were removed from respiratory support in the immediate period prior to death.  There is no explanation for the removal of the infants from breathing support. However, the policies surrounding removal of treatment should have been thoroughly investigated by Dr Evans, as they may provide alternative explanations for the collapse of the infants.