Specialist teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality
Abstract
Background
Maternal antenatal transfers provide better neonatal outcomes. However, there will inevitably be some infants who require acute transport to a neonatal intensive care unit (NICU). Because of this, many institutions develop services to provide neonatal transport by specially trained health personnel. However, few studies report on relevant clinical outcomes in infants requiring transport to NICU.
Objectives
To determine the effects of specialist transport teams compared with non‐specialist transport teams on the risk of neonatal mortality and morbidity among high‐risk newborn infants requiring transport to neonatal intensive care.
Search methods
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), MEDLINE (1966 to 31 July 2015), EMBASE (1980 to 31 July 2015), CINAHL (1982 to 31 July 2015), conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi‐randomised trials.
Selection criteria
Study design: randomised, quasi‐randomised or cluster randomised controlled trials.
Population: neonates requiring transport to a neonatal intensive care unit.
Intervention: transport by a specialist team compared to a non‐specialist team.
Outcomes: any of the following outcomes — death; adverse events during transport leading to respiratory compromise; and condition on admission to the neonatal intensive care unit.
Data collection and analysis
The methodological quality of the trials was assessed using the information provided in the studies and by personal communication with the author. Data on relevant outcomes were extracted and the effect size estimated and reported as risk ratio (RR), risk difference (RD), number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH) and mean difference (MD) for continuous outcomes. Data from cluster randomised trials were not combined for analysis.
Main results
One trial met the inclusion criteria of this review but was considered ineligible owing to serious bias in the reporting of the results.
Authors' conclusions
There is no reliable evidence from randomised trials to support or refute the effects of specialist neonatal transport teams for neonatal retrieval on infant morbidity and mortality. Cluster randomised trial study designs may be best suited to provide us with answers on effectiveness and clinical outcomes.
PICO
Plain language summary
Specialist teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality
Review question: Do specialist transport teams compared with non‐specialist transport teams improve clinical outcome for newborn infants in need of transport to neonatal intensive care?
Background: High‐risk newborn infants tend to have better outcomes if born in a centre with a Neonatal Intensive Care Unit (NICU). Although it is advocated that women with high risk factors be transferred to centres with NICU facilities for delivery, at times it is inevitable that birth occurs at centres that are unable to treat their newborns. Therefore, the need for specially trained neonatal transport health personnel is important to ensure that these infants are stabilised and transported to hospitals with an NICU. This review was conducted to find out whether specially trained neonatal transport teams, compared with general transport teams, had better clinical outcomes.
Study characteristics: No eligible trials were identified for inclusion in this review.
Key results: There is no evidence from randomised controlled trials to support or refute that specialist teams for neonatal transport reduce mortality and morbidity among newborn infants requiring retrieval to an NICU. It may be necessary to rely on evidence from cluster trials (where groups of hospitals are compared) or good quality non‐randomised study designs to provide answers to this question.
Authors' conclusions
Background
Description of the condition
The American Academy of Pediatrics (AAP Policy statement 2012) classifies treatment centres offering neonatal care into four levels:
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Level I: well newborn nurseries providing basic level of care to neonates who are low risk and have capabilities for neonatal resuscitation.
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Level II: care reserved for stable or moderately ill newborn infants born at ≥ 32 weeks’ gestation or birth weight ≥ 1500 grams with problems that are expected to resolved rapidly and who would not be anticipated to require subspecialty‐level services on an urgent basis.
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Level III: care in Neonatal Intensive Care Units (NICU) having continuously available personnel (neonatologists, neonatal nurses, respiratory therapists) and equipment to provide life support for as long as necessary. These centres have Pediatric subspecialist and Pediatric Surgery services.
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Level IV: these consist of level 3 care with additional capabilities and experience in the care of the most complex and critically ill newborn infants.
Level III and IV units are tertiary units.
High‐risk newborns managed in tertiary neonatal care facilities have lower morbidity and mortality rates than those managed in lower levels (Paneth 1982). Therefore, it is vital that all high‐risk newborns have access to a tertiary NICU. Although maternal antenatal transfer provides more favourable neonatal outcomes (Lamont 1983; Chien 2001; Hohlagschwandtner 2001), some infants will inevitably require urgent transport to a higher‐level care centre in the post‐birth period. This occurs for two main reasons: 1) in‐utero transfer was not feasible or did not occur and 2) maternal transfer was thought unnecessary but the baby developed unanticipated clinical problems following birth (Lupton 2004). In view of this, neonatal transport has been an important component of perinatal service provision since the 1960s (Canadian Department of National Health 1975; Public Health Agency of Canada 1988; Day 1991; AAP 2002; Woodward 2002).
Description of the intervention
Various health care facilities deploy different types of transport teams for neonatal retrievals from lower‐level to tertiary centres. These teams range from specialist‐trained teams to general transport service teams with varying experiences in neonatal transport (Rashid 1999; Leslie 2003; Kempley 2004; Lupton 2004; McNamara 2005). Specialist‐trained neonatal transport teams consist of individuals who have undergone specific theoretical and practice‐based training to develop skills in the safe stabilisation and transport of infants. Various types of team composition have been reported in the literature. For example Rashid 1999 and McNamara 2005 examined the effectiveness of doctor–nurse teams compared to teams consisting of registered nurses and combined registered nurse–respiratory therapist teams. Lee 2002 compared three types of teams—emergency medical technicians, registered nurses and combined registered nurse–respiratory therapist teams—and Leslie 2003 compared advanced neonatal nurse practitioners with doctor‐led teams. The majority of these studies reported a range of varying clinical outcomes.
How the intervention might work
A specialist‐trained neonatal transport team is likely to have the practical skills, knowledge and experience to better manage clinical problems occurring in critically ill newborn infants during stabilisation and transport. Examples of commonly occurring clinical problems the team may need to address include respiratory failure, hypothermia, hypoglycaemia, pneumothorax, haemodynamic instability, respiratory emergencies (air leak, airway obstruction and displacement of the endotracheal tubes). A specialist team is likely to more effectively monitor for such conditions leading to earlier and more accurate diagnosis. Interventions to address common conditions affecting newborn infants during transport such as resuscitation, respiratory support, appropriate thermal management, urgent umbilical or peripheral line placement for administration of fluids and emergency medications, and needle thoracentesis/chest tube insertion etc. are better managed by a specialist‐trained neonatal transport team owing to their knowledge and skill in advanced techniques, and familiarity with the administration of specific medications and equipment used during initial stabilisation and transport of the critically ill neonate. McNamara 2005 demonstrated that a specialised neonatal retrieval team was better skilled at resuscitating infants at birth than the referring hospital team. Leslie 2003 showed that specialist advanced neonatal nurse practitioner‐led transport teams were as effective as doctor‐led teams in supporting newborns during transportation to the NICU.
Why it is important to do this review
Specialist teams for neonatal transport may be expensive to set up and maintain in situations where the volume of neonatal transports is low. In addition, the teams will need to maintain their skills through simulation or other methods which further imposes on time and resources. Therefore, this systematic review examines the evidence as to whether specialist teams for neonatal transport to neonatal intensive care units results in better outcomes and decreases mortality and morbidity among newborn infants.
Objectives
To determine whether
1. Specialist versus non‐specialist teams, and;
2. Subgroups; type of specialist team, gestational age, birthweight, disease severity and mode of transport;
have an effect on morbidity and mortality in neonates requiring transfer to neonatal intensive care facilities.
Subgroups:
Population subgroups:
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Type of specialty teams: In various combinations consisting of at least two people of the following:
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Medical – neonatologist, neonatal trainee, paediatrician, others
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Nursing – general nurse, neonatal specialist, neonatal nurse practitioner, midwife
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Combination
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Type of training received:
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Formal training by clinical services
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No formal training
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Gestational age:
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< 32 weeks
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≥ 32 weeks
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Birth weight:
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< 1500 grams
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≥ 1500 grams
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Resuscitation at birth:
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Specialist team present and resuscitated the infants at birth prior to transport
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Infants resuscitated by the team at the referring hospital and then transported by the specialty team
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Disease severity prior to the arrival of the transport team at referring hospitals:
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Respiratory support required
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Fraction of inspired oxygen (FiO₂): ≤ 0.40, > 0.40
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Mean airway pressure: ≤ 10 mm Hg, > 10 mm Hg
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Oxygenation index: ≤ 25, > 25
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Need for continuous positive airway pressure (CPAP)
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Hypoxic‐ischaemic encephalopathy (HIE) – Sarnat Stage 1, 2 or 3 (Sarnat 1976)
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Congenital abnormalities
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Mode of transport:
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Road
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Air (helicopters or aircraft)
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Level of perinatal care at referring site
Methods
Criteria for considering studies for this review
Types of studies
All trials using random, quasi‐random and cluster random allocation that met the inclusion criteria for types of participant, interventions and outcome.
Types of participants
Neonates (with chronological age of 28 days or less irrespective of postmenstrual age at birth) requiring transport to a neonatal intensive care unit.
Types of interventions
Transport by a specialist team compared to a non‐specialist team. Specialist teams consist of at least two people who had formal training in neonatal transport. Non‐specialist teams consist of general transport teams or people working in a neonatal unit on a regular basis with transport responsibilities but had not undergone formal training in neonatal transport.
Types of outcome measures
1. Primary outcomes:
Deaths occurring:
a. During transport‐team stabilisation. (Stabilisation time is defined as the time interval between arrival at the referring hospital and departure of the transport team);
b. During transport (defined as between time of departure from the referring hospital and arrival at the NICU);
c. Within 24 hours of NICU admission;
d. Prior to NICU discharge.
2. Secondary outcomes
a. Adverse events during transport leading to respiratory compromise:
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displacement of endotracheal tube;
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obstruction of airway;
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pneumothorax.
b. Condition on admission to the neonatal intensive care unit
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Respiratory support required: Fraction of inspired oxygen (FiO₂); Mean airway pressure; Oxygenation index; Need for continuous positive airway pressure (CPAP);
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Measures of physiologic stability on blood gases: pH, PaO₂, PCO₂;
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Incidence of reported hypothermia as defined in the trial;
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Incidence of reported hypotension (systolic or mean blood pressure more than 2 standard deviations below the mean for gestational age);
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Incidence of reported hypoglycaemia as defined in the trial;
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Evidence of any encephalopathy (classified by a valid method like Sarnat 1976).
Search methods for identification of studies
We used the criteria and standard methods of Cochrane and the Cochrane Neonatal Review Group (CNRG) (see the Cochrane Neonatal Group search strategy for specialized register). We conducted a comprehensive search including: Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7) in The Cochrane Library; MEDLINE via PubMed (1996 to 31 July 2015); EMBASE (1980 to 31 July 2015); CINAHL (1982 to 31 July 2015) using the following search terms: (neonat* transport OR neonat* retrieval OR newborn OR infant OR patient care transport OR transportation of patient OR specialized transport team) AND (neonatal intensive care units OR NICU), plus database‐specific limiters for RCTs and neonates (see Appendix 1 for the full search strategies for each database). No language restrictions were applied.
We searched clinical trials registries for ongoing or recently completed trials (clinicaltrials.gov; the World Health Organization’s International Clinical Trials Registry Platform www.whoint/ictrp/search/en/; the ISRCTN registry http://www.isrctn.com/; and the Australian New Zealand Clinical Trials Registry anzctr.org.au). In addition, we reviewed the reference lists of retrieved articles and had personal communication with primary authors and with experts in the field, when necessary, to identify unpublished data.
Data collection and analysis
We used the standard methods of the CNRG.
Selection of studies
Two review authors (AC, SS) performed the searches and independently assessed retrieved reports for eligibility and methodological quality. If needed, they planned to consult a third author (AB) for unresolved differences.
Data extraction and management
Two reviewers planned to perform the data extraction independently and if necessary, seek agreement by consensus.
Assessment of risk of bias in included studies
The authors planned to use the following criteria to assess trial quality: blinding of randomisation, blinding of intervention, completion of follow‐up, and blinding of outcome assessment. If the method was not stated and randomisation could have been used, attempts would be made to contact authors for further information.
If studies were identified, it was planned to evaluate and enter the information below in the 'Risk of bias' table:
(1) Sequence generation (checking for possible selection bias). Was the allocation sequence adequately generated?
For each included study, it was planned to categorise the method used to generate the allocation sequence as:
‐ adequate (any truly random process e.g. random number table; computer random number generator);
‐ inadequate (any non‐random process e.g. odd or even date of birth; hospital or clinic record number);
‐ unclear.
(2) Allocation concealment (checking for possible selection bias). Was allocation adequately concealed?
For each included study, it was planned to categorise the method used to conceal the allocation sequence as:
‐ adequate (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
‐ inadequate (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth);
‐ unclear.
(3) Blinding (checking for possible performance bias). Was knowledge of the allocated intervention adequately prevented during the study? At study entry? At the time of outcome assessment?
For each included study, it was planned to categorise the methods used to blind study participants and personnel from knowledge of which intervention a participant received. It was planned to assess blinding separately for different outcomes or classes of outcomes. The methods were categorised as:
‐ adequate, inadequate or unclear for participants;
‐ adequate, inadequate or unclear for personnel;
‐ adequate, inadequate or unclear for outcome assessors.
(4) Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations). Were incomplete outcome data adequately addressed?
For each included study and for each outcome, it was planned to describe the completeness of data including attrition and exclusions from the analysis. It was planned to note whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported or supplied by the trial authors, it was planned to re‐include missing data in the analyses. It was planned to categorise the methods as:
‐ adequate (< 20% missing data);
‐ inadequate (≥ 20% missing data):
‐ unclear.
(5) Selective reporting bias. Are reports of the study free of suggestion of selective outcome reporting?
For each included study, it was planned to describe how we investigated the possibility of selective outcome reporting bias and what was found. It was planned to assess the methods as:
‐ adequate (where it is clear that all of the study’s pre‐specified outcomes and all expected outcomes of interest to the review have been reported);
‐ inadequate (where not all the study’s pre‐specified outcomes have been reported; one or more reported primary outcome was not pre‐specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);
‐ unclear.
(6) Other sources of bias. Was the study apparently free of other problems that could put it at a high risk of bias?
For each included study, it was planned to describe any important concerns the authors had about other possible sources of bias (for example, whether there was a potential source of bias related to the specific study design or whether the trial was stopped early due to some data‐dependent process). It was planned to assess whether each study was free of other problems that could put it at risk of bias as:
‐ yes; no; or unclear.
If needed, it was planned to explore the impact of the level of bias through undertaking sensitivity analyses.
Measures of treatment effect
It was planned to report the risk ratio (RR), risk difference (RD), number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH) derived from 1/RD for dichotomous outcomes and weighted mean difference for continuous outcomes with the 95% confidence intervals (CI). It was planned to use standardised mean difference where trials reported continuous outcomes using different measurement scales.
Data synthesis
It was planned to perform data synthesis using the standard methods of the CNRG.
If sufficient studies were located and deemed to be appropriate to group together for analysis, the authors planned to use a fixed‐effect model.
For the analysis of cluster trials, it was planned to use the inverse variance (IV) method. The IV method assumes that the individual cluster trial had been correctly analysed (for example, the unit of analysis is the cluster not individuals and the analysis takes into account the correlation between clusters). It was planned to obtain professional statistical advice as required to conduct these analyses.
Subgroup analysis and investigation of heterogeneity
The following subgroups were identified for analysis a priori:
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Type of specialist teams: In various combinations consisting of at least two people of the following:
-
Medical – neonatologist, neonatal trainee, paediatrician, others
-
Nursing – general nurse, neonatal specialist, neonatal nurse practitioner, midwife
-
Combination
-
-
Gestational age:
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< 32 weeks
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≥ 32 weeks
-
-
Birth weight:
-
< 1500 grams
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≥ 1500 grams
-
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Disease severity prior to the arrival of the transport team at referring hospitals:
-
Respiratory support required
-
Fraction of inspired oxygen (FiO₂): ≤ 0.40, > 0.40
-
Mean airway pressure: ≤ 10 mm Hg, > 10 mm Hg
-
Oxygenation index: ≤ 25, > 25
-
Need for continuous positive airway pressure (CPAP)
-
-
Hypoxic‐ischaemic encephalopathy (HIE) – Sarnat Stage 1, 2 or 3 (Sarnat 1976)
-
Congenital abnormalities
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-
Mode of transport:
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Road
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Air (helicopters or fixed wing aircrafts)
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Level of perinatal care at referring site
Results
Description of studies
No studies were found to meet the inclusion criteria after an extensive search.
Excluded studies
A study by Chance 1978, which compared specially trained transport teams, consisting of two neonatal intensive care nurses and one neonatal fellow, with controls. Allocation to either team was done from a randomly ordered deck of cards after receiving a request for a transport team. Transport of infants allocated to the specialist team was only done if they were available at randomisation, otherwise the infants were re‐assigned to the control group. Data analyses compared outcomes for specialist‐team (n = 22) and control (n = 12) groups at the time of randomisation. However, the group supposed to receive specialist team transport but reassigned to the control arm owing to lack of availability of the specialist team were not included in the analysis. The authors noted that infants who received specialist team transport had significantly lower hypothermia and hypotension on admission to the NICU. Blood pH levels and oxygenation were higher in the study group. Mortality rates and duration of intensive care were also lower in the study group. However, there were no significant differences in the duration of ventilation and sepsis.
Team availability rather than randomisation alone determined whether the infants were transported by the specialist team or the control group and the number of infants reassigned to the control group was not reported in the results. It is logical to expect that the sample size in the study population should be lower compared with the control group. Therefore, the author was contacted for further clarification and confirmed that the results of this study may have been reported in a way that favoured the study population (i.e. reporting bias). This study was later withdrawn from publication after this was noted to the editor. On this basis it was decided not to include analyses from this study as part of this review.
Risk of bias in included studies
No studies were found to meet the inclusion criteria after an extensive search.
Effects of interventions
No studies were found to meet the inclusion criteria after an extensive search.
Discussion
There is insufficient evidence to support or refute the use of specialist teams for neonatal transport in improving outcomes. Although this review yielded one trial which favoured the utilisation of specialist‐trained neonatal transport teams for better clinical outcomes, it was excluded owing to the likelihood of serious bias in outcome reporting and subsequent withdrawal of the study from publication. It may be challenging to conduct trials comparing specialist‐trained neonatal transport teams with general transport teams in the context of modern neonatal care where rapid adoption of specialist neonatal teams servicing a regionalised neonatal care model is being implemented worldwide. However, evidence from studies of improved outcomes with specialist neonatal teams may provide justification for increased uptake in countries where previously inadequate health care models and resources are rapidly evolving.
Of great importance may be the composition of specialist teams in providing the level of skills and knowledge required to achieve the best infant outcomes. In view of ethical, technical and logistic challenges involved in conducting a rigorous randomised controlled trial comparing clinical effectiveness of specialist transport team with non‐specialist teams, it may be feasible to conduct cluster randomised trials – comparing different institutions or regions within a healthcare system and comparing different categories of specialist transport staff.
