Specialty teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality (Protocol)

Transcription

1 Specialty teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality (Protocol) Chang ASM, Berry A, Sivasangari S This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2008, Issue 4

2 T A B L E O F C O N T E N T S HEADER ABSTRACT BACKGROUND OBJECTIVES METHODS REFERENCES HISTORY CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT i

3 [Intervention Protocol] Specialty teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality Alvin SM Chang 1, Andrew Berry 2, Subramaniam Sivasangari 3 1 Department of Paediatrics, Selayang Hospital, Batu Caves, Malaysia. 2 NSW Neonatal and Paediatric Emergency Transport Service, Western Sydney Area Health Service, Wentworthville, Australia. 3 Department of Paediatrics, Royal College of Medicine Perak, Ipoh, Malaysia Contact address: Alvin SM Chang, Department of Paediatrics, Selayang Hospital, Lebuhraya Selayang-Kepong, Batu Caves, Selangor, 8100, Malaysia. alvinchang72@hotmail.com. Editorial group: Cochrane Neonatal Group. Publication status and date: New, published in Issue 4, Citation: Chang ASM, Berry A, Sivasangari S. Specialty teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD DOI: / CD A B S T R A C T This is the protocol for a review and there is no abstract. The objectives are as follows: Primary Objective: To determine whether specialty transport teams compared with non-specialty transport teams affect neonatal mortality and morbidity among newborn infants in need of transport to neonatal intensive care. Secondary Objective: To determine the effect on outcome depending on the types of specialty teams, gestational age, birth weight, disease severity and mode of transport for newborns requiring transfer to neonatal intensive care units (NICUs). Subgroups: Population subgroups: 1. Type of specialty teams: In various combinations consisting of at least two people of the following a. Medical - neonatologist, neonatal trainee, paediatrician, others b. Nursing - general nurse, neonatal specialist, neonatal nurse practitioner, midwife c. Combination 2. Gestational age: a. < 32 weeks b. > 32 weeks 3. Birth weight: a. < 1500 grams 1

4 b. > 1500 grams 4. Disease severity prior to the arrival of the transport team at referring hospitals a. Respiratory support required i. Fraction of inspired oxygen (FiO 2 ) - < 0.40, > 0.40 ii. Mean airway pressure - < 10 mmhg, > 10 mmhg iii. Oxygenation index -< 25, > 25 iv. Need for continuous positive airway pressure (CPAP) b. Hypoxic-ischaemic encephalopathy (HIE) - Sarnat Stage 1, 2 or 3 (Sarnat 197) c. Congenital abnormalities 5. Mode of transport a. Road b. Air (helicopters or airplanes). Level of perinatal care at referring site 2

5 B A C K G R O U N D Description of the condition Critically ill newborns managed in a Neonatal Intensive Care Unit (NICU) have lower morbidity and mortality rates than those not admitted to an NICU (Paneth 1982). It is vital that accessibility to a tertiary NICU be available for all unstable newborn infants. Although maternal antenatal transfer provides more favourable outcomes for ill newborns (Hohlagschwandtner 2001; Lamont 1983; Chien 2001), some infants will inevitably need to be transported acutely to NICUs (Lupton 2004). In view of this, neonatal transport had been incorporated as an important component in providing perinatal services since the 190 s (Canadian Health 1975; Nat Guidelines 1988; Perinatal Care 2002; Woodward 2002; Day 1991). Description of the intervention Various health care facilities deploy different types of transport teams for neonatal retrievals to tertiary centres. These teams range from specialist-trained teams to general transport service teams and have varying experiences in neonatal transport (Lupton 2004; Kempley 2004; Rashid 1999; McNamara 2005; Leslie 2003). Specialised neonatal transport teams consist of individuals trained in skills and knowledge on safe stabilisation and transport of infants. These teams consist of combinations of doctors, nurses and paramedics employed by various organizations (Rashid 1999; McNamara 2005; Leslie 2003; Lee 2002). How the intervention might work There are only a few outcome studies comparing newborns transported by specially trained personnel with a general transport team available in the literature. McNamara 2005 demonstrated that a specialized neonatal retrieval team was more skilful than the referring hospital team at resuscitating infants at birth. Leslie et al (Leslie 2003) showed that a specially trained advanced neonatal nurse practitioner-led transport team was as effective as a doctorled team in supporting newborns during transportation to the NICU. The literature has not addressed important clinical issues such as short and long-term mortalities and morbidities of infants transported to NICUs. Short-term outcomes such as the clinical condition of the newborns at admission to the NICU and within 24 hours of admission are important indicators of the effectiveness of specialized transport teams. No data is available pertaining to the long-term outcomes (respiratory, neurodevelopmental etc) of these infants. Why it is important to do this review This systematic review will examine the evidence regarding whether specialty teams for neonatal transport to neonatal intensive care units decrease mortality and morbidity among newborn infants. In addition, the review will evaluate whether specialized teams consisting of various combinations of paramedics, nurses or doctors result in differences in the outcome of the infants. Subgroup analysis will evaluate whether factors related to the transported infants (gestational age, disease process, condition at first assessment of the transport team etc.) have any bearings on outcomes. O B J E C T I V E S Primary Objective: To determine whether specialty transport teams compared with non-specialty transport teams affect neonatal mortality and morbidity among newborn infants in need of transport to neonatal intensive care. Secondary Objective: To determine the effect on outcome depending on the types of specialty teams, gestational age, birth weight, disease severity and mode of transport for newborns requiring transfer to neonatal intensive care units (NICUs). Subgroups: Population subgroups: 1. Type of specialty teams: In various combinations consisting of at least two people of the following a. Medical - neonatologist, neonatal trainee, paediatrician, others b. Nursing - general nurse, neonatal specialist, neonatal nurse practitioner, midwife c. Combination 2. Gestational age: a. < 32 weeks b. > 32 weeks 3. Birth weight: a. < 1500 grams b. > 1500 grams 4. Disease severity prior to the arrival of the transport team at referring hospitals a. Respiratory support required i. Fraction of inspired oxygen (FiO 2 ) - < 0.40, >

6 ii. Mean airway pressure - < 10 mmhg, > 10 mmhg iii. Oxygenation index -< 25, > 25 iv. Need for continuous positive airway pressure (CPAP) b. Hypoxic-ischaemic encephalopathy (HIE) - Sarnat Stage 1, 2 or 3 (Sarnat 197) c. Congenital abnormalities 5. Mode of transport a. Road b. Air (helicopters or airplanes). Level of perinatal care at referring site M E T H O D S Criteria for considering studies for this review Types of studies All trials using random, quasi-random and cluster random allocation that meet the inclusion criteria for types of participant, interventions and outcome will be included. 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 team consisting of at least two people who had formal training by local governing bodies in neonatal transport. Non-specialist team consists 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 stabilising time by the transport team (stabilising time is defined as the time interval between arrival at the referring hospital and departure by the transport team). b. during transport (occurring between departure from the referring hospital and arrival at the NICU) c. within 24 hours of admission to the NICU d. prior to discharge from NICU 2. Secondary outcomes a. Adverse events during transport leading to respiratory compromise: i. displacement of endotracheal tube ii. obstruction of airway iii. pneumothorax b. Condition on admission to the neonatal intensive care unit i. Respiratory support required: Fraction of inspired oxygen (FiO 2 ); Mean airway pressure; Oxygenation index; Need for continuous positive airway pressure (CPAP) ii. Incidence of reported hypothermia as defined in the trial iii. Incidence of reported hypotension (systolic or mean blood pressure more than 2 standard deviations below the mean for gestational age) iv. Incidence of reported hypoglycaemia as defined in the trial v. Evidence of any encephalopathy (classified by a valid method like Sarnat 197) Search methods for identification of studies See Neonatal Group search strategy The standard search strategy of the Neonatal Review Group, as outlined in The Cochrane Library, will be used. The following sources will be searched for eligible reports in any language: a. Cochrane Controlled Trials Register in the current Cochrane Library. b. MEDLINE, EMBASE and CINAHL electronic searches from 19 up to date using the terms: neonat* transport, neonat* retrieval, newborn, infant, clinical trials, neonatal intensive care units, specialized transport team. c. Reference lists from the above, and from review articles d. Personal communication with primary authors from the above, and with experts in the field, to identify unpublished data e. Previous reviews including cross-references, abstracts, conferences, symposia proceedings, expert informants and journal hand searching Data collection and analysis The standard methods of the CNRG will be used. Two review authors (AC, SS) will do the searches. Independent assessment of retrieved reports for methodological quality and eligibility will be performed by both review authors. A third person (AB) will be sought for unresolved differences. Criteria to be used for assessment of trial quality will be blinding of randomization, blinding of intervention, completion of follow-up and blinding of outcome assessment. Agreement about trial inclusion will be reached by consensus. Data extraction will be done independently by two review authors and agreement reached by consensus. If the method is not stated and randomisation could have been used, attempts will be made to contact authors for further information. 4

7 Data will be synthesized using the standard methods of the CNRG. This includes use of relative risk (RR), risk difference (RD), number needed to treat (NNT) or number needed to harm (NNH) derived from 1/RD, and mean difference for continuous outcomes. For each estimate of effect the 95% confidence intervals will be given in brackets. A fixed effects model will be used. Heterogeneity will be estimated using the I squared statistic. If heterogeneity is observed, a sensitivity analysis will be performed based on trial quality. For the analysis of cluster trials, we will use the inverse variance (IV) method. The IV method assumes that the individual cluster trial had been correctly analyzed (for example, the unit of analysis is the cluster not individuals and the analysis takes into account the correlation between clusters). Professional statistical advice may be required to conduct these analyses. Although the inverse variance methodology permits combined meta-analysis of cluster and non-cluster trials, interpretation of such a combined analysis is not straightforward as cluster trials makes inferences about a group rather than individuals. Therefore, combined meta-analysis of cluster and non-cluster trials will not be performed. R E F E R E N C E S Additional references Canadian Health 1975 Recommended standards for maternity and newborn care. Health and Welfare Canada Chien 2001 Chien YL, Whyte R, Aziz K, Thiessen P, Matthew D, Lee SK. Improved outcome of preterm infants when delivered in tertiary care centers. Obstetrics and Gynecology 2001;98: Day 1991 Day S, McCloskey K, Orr R, Bolte R, Notterman D. Pediatric interhospital critical care transport: concensus of a national leadership conference. Pediatrics 1991;88: Hohlagschwandtner 2001 Hohlagschwandtner P, Husslein P, Klerbermass K, Weninger M, Nardi A, Langer M. Perinatal mortality and morbidity. Comparison between maternal transport, neonatal transport and inpatient antenatal treatment. Archives of Gynecology and Obstetric 2001;25: Kempley 2004 Kempley ST, Sinha AK, Thames Regional Perinatal Group. Census of neonatal transfers in London and the South East of England. Archives of Disease in Childhood Fetal and Neonatal Edition 2004;89:F521. Lamont 1983 Lamont RF, Dunlop PD, Crowley P, Levene MI, Elder MG. Comparative mortality and morbidity of infants transferred in utero or postnatally. Journal of Perinatal Medicine 1983; 11: Lee 2002 Lee SK, Zupancic JA, Sale J, Pendray M, Whyte R, Brabyn D, Walker R, Whyte H. Cost-effectiveness and choice of infant transport systems. Medical Care 2002;40: Leslie 2003 Leslie S, Stephenson T. Neonatal transfers by advanced neonatal nurse practitioners and paediatric registrars. Archives of Disease in Childhood Fetal and Neonatal Edition 2003;88:F Lupton 2004 Lupton BA, Pendray MR. Regionalized neonatal emergency transport. Seminars in Neonatology 2004;9: McNamara 2005 McNamara PJ, Mak W, Whyte HE. Dedicated neonatal retrieval teams improve delivery room resuscitation of outborn premature infants. Journal of Perinatology 2005;25: Nat Guidelines 1988 Family centered maternity and newborn care. National guidelines. Health and Welfare Canada Paneth 1982 Paneth N, Kiely JL, Wallenstein S, Marcus M, Pakter J, Susser M. Newborn intensive care and neonatal mortality in low-birth-weight infants. A population study. New England Journal of Medicine 1982;307: Perinatal Care 2002 Guidelines for Perinatal care 5th Edition. American Academy of Pediatrics/American College of Obstetricians and Gynecologists Rashid 1999 Rashid A, Bhuta T, Berry A. A regionalised transport service, the way ahead?. Archives of Disease in Childhood 1999;80: Sarnat 197 Sarnat H, Sarnat M. Neonatal encephalopathy following fetal distress. A clinical and electrographic study. Archives of Neurology 197;33: Woodward 2002 Woodward GA, Insoft RM, Pearson-Shaver AL, Jaimovich D, Orr RA, Chambliss R, et al.the state of Pediatric interfacility transport: consensus of the second national Pediatric and Neonatal Interfacility Transport Medicine Leadership Conference. Pediatric Emergency Care 2002;18: Indicates the major publication for the study 5

8 H I S T O R Y Protocol first published: Issue 4, 2008 C O N T R I B U T I O N S O F A U T H O R S AC wrote the drafts of the protocol where SS and AB edited and offered their comments prior to submission. D E C L A R A T I O N S O F None I N T E R E S T S O U R C E S O F S U P P O R T Internal sources New South Wales Newborn and Paediatric Emergency Transport Services (NETS), Australia. Centre for Perinatal Health Services Research, Australia. External sources SEA-ORCHID, Australia. National Health and Medical Research Council, Australia. Wellcome Trust, UK.