Therapeutic hypothermia (TH) is the standard of care for managing newborns (NBs) with perinatal hypoxic-ischaemic encephalopathy (HIE). Although TH is used widely, the management of these infants must be improved to optimise the outcomes of this intervention. To this end, it is essential that protocols for the care of NBs with HIE involve a holistic approach with continuity of care from birth through the development of a post-discharge follow-up plan.1,2 Within this holistic approach, neurologic monitoring, sedation and other aspects of care during TH and the tools used to assess the extent of brain injury are relevant aspects in the management of NBs with HIE.3–5

At present, evidence is available on the implementation of TH in NBs with HIE in most European countries, but this evidence hardly offers information on how the care is actually delivered, including whether there is a care protocol, the type of neurologic monitoring used, or the approach to making a neurologic prognosis. There is also a paucity of information on the challenges faced by medical professionals in estimating the severity of injury, in informing families and on the participation in care delivery of the nursing staff. Such information would allow us to identify opportunities for improvement and to promote the necessary changes to optimise the holistic management of NBs with HIE.6

With the aim of understanding the current situation in the management of NBs with HIE and identify current needs and areas of improvement, we conducted a nationwide cross-sectional study on moderate-to-severe HIE in 2015. The data concerning the incidence of HIE, adherence to the use of TH and the management of NBs with perinatal asphyxia eligible for TH in the first hours of life have been published in previous documents.7,8

The objectives of this study were: (1) assessing whether there was a protocol in place for the care of NBs with HIE from initiation of TH to the discharge home; (2) which neurologic monitoring and diagnostic tools were used to make a prognosis and how they were used and (3) identify the main needs and difficulties reported by health care providers.

We conducted a nationwide cross-sectional study on moderate-to-severe HIE in NBs delivered at or after 35 week's gestation by means of an online survey. The study included every tertiary care hospital in Spain, public or private, with level II or III units that provided TH in June 2015 (n=57).7,8

The questionnaire comprised 119 items in 5 sections: (1) availability of protocols and technological resources (Tables 1 and 2); (2) use or neurological monitoring systems (Table 3); (3) knowledge of health care providers (Table 4); (4) aspects concerning prognosis and related information (Tables 5 and 6), and (5) aspects related to the discharge report and the followup plan (Table 7).

The study was approved by the research committee of the coordinating hospital.

All 57 tertiary care hospitals with level II–III units that provided TH responded to the survey.

Post-discharge follow-up plan (Table 7)

Nearly all hospitals followed up patients with moderate-to-severe HIE after discharge, and 48% also frequently followed up patients with mild HIE. The professional in charge of follow-up was usually a paediatric neurologist (84%), and only 41% of hospitals where a neonatologist was in charge of the follow-up reported that the neonatologist had specific training on neurodevelopment.

All hospitals included the findings of the tests performed and of the neurologic examination in the discharge summary, although 65% rarely added remarks on the patient's prognosis. They also reported often making recommendations on care, establishing a follow-up plan and determining which physicians will care for the patient after discharge.

Fig. 1 summarises the quality of care to NBs with HIE in hospitals that use TH in Spain in terms of treatment variables, information about prognosis, discharge and post-discharge follow-up and staff knowledge.

Figure 1.

Quality of the care delivered to newborns with HIE managed with therapeutic hypothermia in the 57 hospitals that offer therapeutic hypothermia in Spain. We assigned 1 point if the hospital answered “nearly always” to questions regarding management during hypothermia (items 1–9, 12–19, 22–23), prognosis (items 84, 88, 90, 95, 97–103, 106), post-discharge followup (items 107, 108, 111–119), and current knowledge (items 58–66). For items 95–106, with answers given on a scale of 1 to 5, we assigned a score of 1 if the answer given was 5. For each hospital, we calculated the total score in absolute terms by adding the scores of all the items, and also the total score as a percentage of the maximum possible score. Each boxplot shows the total scores calculated as a percentage of the maximum possible score for all hospitals for each of the dimensions under study.

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The findings of our study suggest that the holistic care of NBs with moderate-to-severe HIE in tertiary hospitals that use TH in Spain is satisfactory overall, although there are areas for improvement.

Since the publication of national guidelines for the use of TH in Spain in 2011,9 this intervention has been introduced rapidly, so that it was used in 57 out of 90 existing tertiary care hospitals in 2015.8 However, there is currently no information on the overall management of HIE in Spain in relation to aspects as relevant as whether management follows a care protocol, the use of neurologic monitoring, the challenges that health providers experience when it comes to assessing the extent of injury or making a neurologic prognosis or whether tertiary care hospitals offer in-house follow-up care after discharge.3

When it came to material resources, we found that tertiary care hospitals in Spain that used TH had the necessary equipment to provide servo-controlled cooling and monitor the electrical brain activity of the NB during hypothermia. The advantages of servo-controlled systems in the delivery of TH are unquestionable in terms of effectiveness and safety.10 One relevant finding was that only 25% of hospitals had more than 1 system to deliver TH and only 26% more than 1 aEEG system. Although the number of systems that should be available per number of NBs in the caseload has not been established, a previous analysis found that in most of Spain, the number of TH and aEEG systems ranged from 1 per 6666 live births and 1 per 2857 live births, respectively.8 Considering that the incidence of HIE is of 1 per 1000 live births, the data suggest that the availability of equipment is insufficient at the population level, with the risk that it may not be possible to offer TH or that it will be provided without adequate monitoring if more than 1 patient need this intervention at the same time.

Neurologic monitoring with aEEG was the tool that supplemented TH most consistently in Spain. This reflects the value of aEEG along with the use of clinical scales for the identification of patients that need TH11–13 and the strong prognostic value of early aEEG.14 On the other hand, many of the electrical seizures experienced by these patients do not manifest as clinical seizures, and without the aEEG, it would not be possible to either detect them or assess their response to treatment.15 Unfortunately, 6 hospitals did not have aEEG available, and half of the hospitals that used aEEG monitoring did not use the information in real time, as nurses, the health care professionals that stay with the NB 24 hours a day, did not interpret the tracings or convey the resulting information to physicians. It is difficult to provide optimal care without the information provided by the aEEG, so it is essential to improve the training of nurses in the use of this monitoring technique.

In our study, the rScO2 and biomarkers of brain injury were the 2 tools used least frequently in clinical practice. There is evidence that some markers, such as protein S-100 or neuron-specific enolase in blood and especially in CSF, are very useful in patients with HIE.16–18 These markers are valuable from a practical standpoint because they help refine the prognosis at a very early stage when the usefulness of MRI is limited, and do not have the drawback of being affected by sedation. The aspect that needs to be improved in the use of these markers is the time it takes to obtain the results.

Neuroimaging tests are key to establish the location and extension of brain injury, have a strong prognostic value and are used all but universally in newborns with HIE in Spain. However, few hospitals used early structural and Doppler ultrasound scans around the time of TH initiation. At this time point, this imaging tests can be very helpful for ruling out structural abnormalities suggestive of metabolic disorders, infection or antenatal hypoxic-ischaemic injury.

When it came to MRI, its use was widespread in the first 6 weeks of life, when this technique can be used to obtain an individualised prognosis in patients with HIE.19,20 However, few hospitals (20%) reported the use of early MRI (first 4 days post birth) with diffusion-weighted imaging and magnetic resonance (MR) spectroscopy, when it allows a more precise estimate of the timing of the hypoxic-ischaemic insult and has a higher prognostic value.21–23

Establishing the prognosis of perinatal hypoxic-ischaemic injury requires that hospitals have these tools available and a staff with the necessary knowledge and experience to be able to interpret their findings. Prognosis in individual patients requires consistency in the information obtained using different methods, and informing the family of the prognosis is always challenging for health care providers.6,24 Therefore, it was no surprise that hospitals demanded additional education with specific practical courses on each of these diagnostic/prognostic tools.

Our findings evince that there are specific aspects of the management of these patients that could be improved.

Thirty percent of hospitals did not use sedation routinely, among other reasons for fear of causing respiratory depression, and half did not use clinical scales to monitor discomfort and pain. However, the stress and discomfort associated with TH can have a noxious effect and reduce the effectiveness of treatment.25–27 Although the clinical practice guidelines of the group on hypothermia (hipoSEN) of the Sociedad Española de Neonatología (Spanish Society of Neonatology), the group developed an addendum in which they recommended sedation of these patients.25 The clinical practice guideline on neonatal HIE of the Spanish Ministry of Health also recommends sedation, acknowledging that the basis of this recommendation is mainly the ethical imperative to alleviate the stress associated with cooling rather than the current scientific evidence.28

On the other hand, the practice of allowing parents to hold their children during TH is rare, despite evidence that this practice can be safe and also beneficial in that it promotes bonding.29,30

Seventy percent of hospitals did not introduce enteral feeding during TH, although evidence from some studies suggests that this is a safe practice31 that may reduce the length of stay and the time it takes to achieve exclusive oral feeding.32 However, it is important to take into account the scarcity of evidence on how to select patients eligible for enteral feeding and how to deliver it.3,33

In our study, we analysed when and how prognostic information is given to the parents. Only one third of hospitals conveyed this information in the first 72h of life, and nearly always in the absence of the nurse. These findings run counter to the need to receive early information30,34 and the important role of the nurse as the main source of information and communication support reported by parents in recent studies.35

Meeting the need for information and communication of parents of newborns with HIE is a complex challenge that requires a collaborative multidisciplinary approach. This complexity is perceived and voiced by health care professionals, as only half of the hospitals reported that their staff had adequate communication and teamwork skills and resources. Openly sharing information and maintaining effective communication are essential tools for the establishment of interdisciplinary cooperation. It is only when such a relationship is established that it is possible to deliver TH effectively and to develop rapport with the family in a way that can support them through the difficult experience that they are going through.

The timing of prognostication is key for the purposes of making decisions regarding withdrawal or withholding of life-sustaining treatment in some patients. If these decisions are delayed, it is possible that newborns with severe brain damage will survive with very severe disability that will limit independent function.36,37 Most patients with HIE die after treatment limitation,38,39 and therefore this decision must be made rigorously, responsibly and logically based on a thorough analysis of prognostic data and taking into account parental values.

We are happy to say that in Spain follow-up care was offered after discharge to all NBs with moderate-to-severe HIE. These infants require care from a multidisciplinary team, but it is helpful if a single member of this team is appointed to coordinate the follow-up and engage in more frequent and close interaction with the family.40 In our country, the main professional responsible for follow-up is the paediatric neurologist, but we found that when the professional in charge was a neonatologist, only one third of neonatologists had specific training on neurodevelopment. In addition, the duration of follow-up varied, and it is important that hospitals that only follow up patients through age 2 years increase this timeframe to 6 years of age, as cognitive and behavioural sequelae in these patients are usually detected between ages 2 and 6 years.40

There are several limitations to our study. The survey methodology carries a risk of bias, as it includes incomplete data in the analysis, and it is possible that some hospitals modified their care practices from the beginning of the study. One of the strengths of the study is that it contributes unique data that were previously unknown and from every hospital delivering TH in Spain, thus offering a comprehensive picture of the care offered newborns with perinatal HIE treated with TH in Spain.

In conclusion, our findings show that the care of NBs with perinatal HIE managed with TH is adequate overall and offers a general picture of the care delivered to these patients, but also revealed important opportunities for improvement. The availability of cooling and monitoring equipment needs to increase proportionally to the size of catchment populations, the training of professionals on the use of this equipment must improve, especially when it comes to the interpretation of aEEG by nurses, the use of sedation during treatment must be expanded, and the post-discharge follow-up of these patients must be extended through at least age 6 years in every hospital.

It is also important to offer education addressing the holistic approach to the management of NBs with HIE, including communication and interdisciplinary teamwork skills. Increasing competence in these areas could optimise physician-nurse collaboration, including the nurse in the delivery of information and in decision-making, and improve the management of complex issues, such as the timeframe in which parents are given prognostic information and allowing parents to hold their children during TH.

The authors did not receive any funding for this work.

The authors have no conflicts of interest to declare.

This project was promoted by the NeNe Foundation, which was instituted as a not-for-profit organisation in 2015 and is devoted to the study and care of newborns with neurologic problems.