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CONTENTS
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xix
UNIT FOUR
Infection and Hematologic Diseases of the Neonate
20 Newborn Hematology, 623
Christopher Mckinney, Beth Boulden Warren, and Susan Harvey
21 Neonatal Hyperbilirubinemia, 662
Beena D. Kamath- Rayne, Patricia A. Froese, and Elizabeth H. Thilo
22 Infection in the Neonate, 692
Mohan Pammi, M. Colleen Brand, and Leonard E. Weisman
UNIT FIVE
Common Systemic Diseases of the Neonate
23 Respiratory Diseases, 729
Sandra L. Gardner, Mary Enzman-Hines, and Michael Nyp
24 Cardiovascular Diseases and Surgical
Interventions, 836
Tara Swanson and Lori Erickson
25 Neonatal Nephrology, 886
Melissa A. Cadnapaphornchai, Danielle E. Soranno, Terri J. Bisio, Rosanne Woloschuk, and Megan Kirkley
27 Genetic Disorders, Malformations, and
Inborn Errors of Metabolism, 969
Anne L. Matthews and Nathaniel H. Robin
28 Neonatal Surgery, 996
Margaret E. Gallagher, Annette S. Pacetti, Harold N. Lovvorn, III, and Brian S. Carter
UNIT SIX
Psychosocial Aspects of Neonatal Care
29 Families in Crisis: Theoretical and Practical
Considerations, 1039
Sandra L. Gardner and Kristin Voos
30 Grief and Perinatal Loss, 1096
Sandra L. Gardner and Brian S. Carter
31 Discharge Planning and Follow- Up of the
Neonatal Intensive Care Unit Infant, 1141
Angel Carter and Brian S. Carter
32 Ethics, Values, and Palliative Care in Neonatal
Intensive Care, 1167
Julie R. Swaney, Nancy K. English, and Brian S. Carter
26 Neurologic Disorders, 929
Ara S. Hall and Daphne A. Reavey
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UNIT ONE EVIDENCE-BASED PRACTICE
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EVIDENCE-BASED
1
CLINICAL PRACTICE
ALFONSO F. PANTOJA AND MARY ENZMAN-HINES
lobally, health care systems are experiencing challenges when evaluating therapies, qual-
G
clinical practice. Over the past several decades, health care disciplines have made major strides to ensure that clinical decisions and actions are based on sound scientific evidence. Expert practice decisions and actions are embedded in a complex web that reflects all forms of knowing and understanding. Each ele­ment of knowing has a similar but distinct founda­tion of reliability and validity. Health care scholars/ researchers who provide direct patient care, admin­istrators, and educators have joined in the effort to identify the most reliable and sound scientific evi­dence available to inform and guide practice.
use evidence. This failure is either from underuse,
overuse, or misuse of evidence-based therapies and/ or system failures.
(EBP) requires the integration of the best research evidence with our clinical expertise and each patient’s unique values and circum­stances.
care could prevent therapeutic disasters resulting from the informal “let’s-try-it-and-see” methods of testing new therapies that are not recognized as risky. The epidemic of retinopathy attributable to the indiscriminate use of supplemental oxygen; gray baby syndrome attributable to the administration of chlor­amphenicol; kernicterus attributable to the introduc­tion of sulfonamides82; and death due to liver toxicity of 40 premature newborns attributable to the admin­istration of a parenteral form of vitamin E (E-Ferol)89 are examples of these therapeutic misadventures in the field of neonatal care. Silverman described how
ity of care, and the risk of adverse events in
20
Often health care systems fail to optimally
92,93
Evidence-based practice
92,93
EBP approaches in all fields of health
painfully slow health care providers were to embrace a culture of skepticism and emphasizes, “We must insist on the highest standards of evidence in studies involving the youngest human beings; and, since there is no short route to this goal, we must prepare to be patient.”82 The use of experimentation and the scientific method has ultimately led to our present views of how to ask and answer clinical questions.
Mistakes have also occurred at the other extreme, resulting in a failure to adopt therapies that are of proven benefit or an assumption that the risks associated with changing practice jus­tify complacency about current treatments. The
significant delay in the adoption of antenatal cortico­steroids by the obstetric community to promote fetal lung maturation the available evidence. One of the most important
benefits of EBP is the constant questioning: “Have our current clinical practices been stud­ied in appropriately selected populations of sufficient size to accurately predict their efficacy, benefit, safety, side effects, and cost?”
EBP is a systematic way to integrate the best patient-centered, clinically relevant research with our clinical expertise and with the unique preferences, concerns, and expec­tations that each patient brings to a clini­cal encounter.92 Furthermore, EBP presents an
opportunity to enhance patient health and illness outcomes, increase staff satisfaction, and reduce health care expenses. There is great interest in
identifying barriers and facilitators that could help in closing the knowledge-to-practice gap that is inherent to the acceptance and adop­tion of EBP by all providers.
23,86
is a good example of failure to use
96
71
BLUE type highlights content that is particularly applicable to clinical settings.
1
2
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UNIT ONE Evidence-Based Practice
FINDING HIGH-QUALITY EVIDENCE
As new therapies are integrated into neonatal care,
health care providers must continue to increase exist­ing knowledge of the health and health problems of newborns. Providers need to formulate well-de-
signed questions about the specific clinical encounter and learn how to evaluate the qual­ity of evidence regarding risks and benefits of new practices. Most clinical questions arise through
daily practice and often involve knowledge gaps in background (general knowledge) and foreground (specific knowledge to inform clinical decisions or actions). The knowledge needs will vary according to the experience of the clinician.
It is not the purpose of this chapter to provide a detailed review of the various research designs that permit reliable scientific inference. Rather, our pur-
pose is to promote the propositions that (1) challenge clinical observations and wisdom by finding the current best evidence and (2) care­fully assess and critique research that supports or challenges the use of new and established clinical practices.
Clinical observations, although valuable in shaping research questions, are limited by selective perception—a desire to see a strate­gy work or fail to work. At times, a single case
or case study may prompt us to question whether we should consider changing current practice. In some situations, much can be learned from carefully maintained databases. Such knowledge is gained only when we have formed databases with clear intentions and have collected the necessary data.
Sinclair and Bracken85 described four levels of
clinical research used to evaluate safety and efficacy of therapies, based on their ability to
provide an unbiased answer. In ascending order,
these are (1) single case or case series reports without controls, (2) nonrandomized studies with historical controls, (3) nonrandomized studies with concurrent controls, and (4) randomized controlled trials (RCTs). RCTs test hypotheses by using randomly assigned treatment and control groups of adequate size to examine the efficacy and safety of a new therapy. In theory, random assignment of the
treatment balances unknown or unmeasured factors that might otherwise bias the outcome of the trial.
A meta-analysis is a systematic review of the current literature that uses statistical methods
92
to combine the results of individual studies and summarizes the results (http://neona-
tal.cochrane.org).22 Tyson97 has suggested criteria
for identifying proven therapies in current literature (Box 1.1). Ideally, therapeutic recommenda-
tions are supported by evidence from system­atic reviews of RCTs; however, such evidence is not always available. It is then important to
have a system to grade the strength of the quality of the evidence found. An international collabo-
ration developed GRADE (Grading of Reco­mmendations Assessment, Development and Evaluation) to provide an explicit strategy for grading evidence and the strength of recom­mendations.44 GRADE classifies the evidence into one of four levels: high, moderate, low, and very low (Table 1.1). The strength of the
recommendation is graded as strong or weak. Factors
BOX
1.1
Reported to be beneficial in a well-performed meta-analysis of all trials
Beneficial in at least one multicenter trial or two single-center trials
Modified from Tyson JE. Use of unproven therapies in clinical practice and research: how can we better serve our patients and their families? Semin Perinatol. 1995;19:98.
TABLE
1.1
LEVEL OF EVIDENCE
1a Systematic reviews of RCTs 1b Individual RCT with narrow confidence interval 1c All or none 2a Systematic review of cohort studies 2b Individual cohort study (including low-quality RCT
3a Systematic review of case-control study 3b Individual case-control study 4 Case-control studies 5 Expert opinion without critical appraisal
RCT, Randomized controlled trial. From Straus SE, Richardson WS, Haynes RB. Evidence-Based Medicine: How to Practice and Teach It. 4th ed. London: Harcourt; 2011.
PROVEN THERAPIES
or
LEVELS OF EVIDENCE
THERAPY/PREVENTION/ETIOLOGY/HARM
[less than 80% follow-up])
TRIP database
searches these
n
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simultaneously
Critically appraised individual
Quality of evidence
articles (article synopses)
Randomized controlled trials
CHAPTER 1 Evidence-Based Clinical Practice
Meta-
analysis
Systematic
reviews
Critically appraised
topics
(evidence syntheses)
3
Filtered information
Cohort studies
Case-controlled studies
Case series/reports
Background information/expert opinion
FIGURE 1.1 Evidence appraisal. (Modified from DiCenso A, Bayley L, Haynes RB: Accessing pre-appraised evidence: fine-tuning the 5S
model into the 6S model. Evid Based Nurs. 2009;12(4):99.)
that influence the strength of the recommendation include desirable or undesirable effects, values, pref­erences, and economic implications (Fig. 1.1).
Although conclusions drawn from quantitative studies (RCTs, meta-analysis of RCTs) are regard­ed as the strongest level of evidence, evidence from descriptive and qualitative studies should be factored into clinical decisions. Qualitative research pro-
vides guidance in deciding whether the find­ings of quantitative studies could be replicated in various patient populations. Qualitative research can also facilitate an understanding of the experience and values of patients, parents, and health care providers. The validity, impor-
tance, and applicability of qualitative studies need to be evaluated in a similar way as quantitative studies.
PRESSURES TO INTERVENE
RCTs of appropriate size are cited as pro­viding the best evidence for guiding clinical decisions; however, many take years to com­plete and publish. Providers find it difficult to delay the introduction of promising therapies.
Bryce and Enkin15 discussed myths about RCTs and rationales for not conducting them. One myth
Unfiltered informatio
is that randomization is unethical. This might
be true in rare instances when an intervention is dramatically effective and lifesaving. The more common situation is one in which there is limited evidence for a current or alternative strategy.
Pressure to intervene is, however, often overpow­ering. Believing that an infant is in trouble, interven­tions occur through a cascade of interventions, one leading to the next and each carrying risk. One of the most frequently cited examples is the epidemic of blindness associated with the unrestricted use of oxygen in newborns.
81,82
Oxygen, used since the early 1900s for resuscitation and treatment of cya­notic episodes, was noted in the 1940s to “correct” periodic breathing in premature infants. After World War II and the introduction of new gas-tight incu­bators, an epidemic of blindness occurred, resulting from retrolental fibroplasia (RLF). Silverman81 point­ed out that although many causes were suspected, it was not until 1954 that a multicenter, controlled trial confirmed the association between high oxygen con­centrations and RLF. Frequently forgotten, however, is that in subsequent years, mortality was increased in infants cared for with an equally experimental regimen of strict restriction of oxygen administration, and many survivors had spastic diplegia. In the 1960s, the introduction of micro techniques for measuring
4
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arterial oxygen tension permitted better monitoring of oxygen therapy, with a reduction in mortality, spastic diplegia, and RLF, now called retinopathy of prematurity (ROP). Severe ROP is currently limited to extremely-low-birth-weight (ELBW) infants.81 Research continues to explore causes, preventive measures, and treatments (see Chapter 31).
Large multinational, pragmatic RCTs to resolve the uncertainty surrounding the most appropriate levels of oxygen saturation in premature infants have been recently con­ducted and the results published.
78,94,95
The publication of the results of the SUPPORT trial94 brought about a significant debate about the ethical aspects of comparative effectiveness research and parental informed consent when one of the ele­ments of the composite outcome was death before discharge.81 The practice of allowing very-low­birth-weight (VLBW) infants to maintain lower oxygen saturations during the first weeks of life had been widely disseminated throughout the United States and the world due to anecdotal reports of a significant decrease in the severity of ROP and blindness with this approach.21 A recent report of five multicenter studies (NEOPROM) with sim­ilar allocations and outcome measures that were prospectively organized with the aim to answer whether extremely premature infants kept at a low or a high oxygen saturation target had different outcomes. These studies are the SUPPORT trial (Surfactant, Positive Pressure and Pulse Oximetry Randomized Trial), the three BOOST II trials from the United Kingdom, Australia, and New Zealand, and the Canadian Oxygen Trial (COT). Low saturation targets (85% to 89%) until 36 weeks postmenstrual age (PMA) are associated with more deaths and more necrotizing enterocolitis (NEC). Higher saturation targets (91% to 95%) are associated with more ROP.76 Results from all five trials were systematically reviewed and a final meta-analysis (the NeOProM) performed to determine optimal oxygen saturation targets for preterm infants (mean gestational age of 26 weeks; mean birth weights of 820 to 850 g).7 At 18 to 24 months corrected age, no significant difference was found between the lower and higher saturation groups in mortality or major disability. 7 Secondary analysis of the data found that the lower saturation group had significantly higher death rates prior to 36 weeks PMA, before discharge from the neonatal intensive care unit (NICU), and before reaching 18
to 24 months’ corrected age, a significantly higher risk of severe NEC and a significantly higher risk of PDA requiring ligation. Preterm infants randomized to the higher saturation group had a significantly higher risk of bronchopulmonary dysplasia (BPD) and ROP requiring treatment but no increase in blindness7 (see Chapter 23).
The desire to see an intervention “work” encour­ages practitioners and investigators to seek early signs of benefit. Long-term effects are frequently overlooked. One reason is that they may not be foreseen. Consider the example of diethylstilbestrol (DES). DES administration to pregnant women was introduced in 1947 without clinical trials to prevent miscarriage, fetal death, and preterm delivery.
15,37
It was thought to be effective after uncontrolled studies despite controlled trials summarized in an overview (meta-analysis) by Goldstein et al.41 (Table 1.2) that showed the opposite. Clearly, DES was not effective, but it continued to be used until the 1970s, when the Food and Drug Administration (FDA) finally disapproved its use. The unforeseen result was that female children born to mothers who were given DES had structural abnormalities of the genital tract, pregnancy complications, decreased fertility, and an increased risk for vaginal adenocarcinoma in young women. Male children had epididymal cysts. This is not the only example of physicians continuing to use therapies that have been shown in RCTs to be of no benefit.
TABLE
1.2
Miscarriage 1.20 0.89–1.62 Stillbirth 0.95 0.50–1.83 Neonatal death 1.31 0.74–2.34 All three 1.38 0.99–-1.92 Prematurity 1.47 1.08–2.00
a
An odds ratio is an estimate of the likelihood (or odds) of being affected by an exposure (e.g., a drug or treatment) compared with the odds of having that outcome without having been exposed. Women receiving diethylstilbestrol did not have fewer stillbirths, premature births, or miscarriages than women who were untreated. Data from Goldstein PA, Sacks HS, Chalmers TC. Hormone administration for the mainte­nance of pregnancy. In Chalmers I, Enkin M, Keirse M, eds. Effective Care in Pregnancy and Childbirth. New York, NY: Oxford University Press; 1989.
18
EFFECTS OF DIETHYLSTILBESTROL ON PREGNANCY OUTCOMES
TYPICAL ODDS
A
RATIO
95% CONFIDENCE LIMITS
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The costs of long-term studies and follow-up surveillance are numerous. However, when effects are measured later in life (e.g., psychological prob­lems, ability to function in school), the cost cannot determine study design. Even when randomized trials are conclusive, unanswered questions remain: Will a technology or treatment have the same effect in all settings? Has an “appropriate” target popula­tion been selected? Are there long-term unforesee­able consequences?
EVALUATION OF THERAPIES
The major cause of death in premature infants is
respiratory failure from respiratory distress syn­drome (RDS) (see Chapter 23). Previously called hyaline membrane disease, this syndrome of expiratory grunting, nasal flaring, chest wall retractions, and cyanosis unresponsive to high oxygen concentra­tions was a mystery until the 1950s.
82
The evaluation of various therapies for RDS contrasts the value of controlled and uncontrolled trials. Sinclair84 noted that uncontrolled studies were more likely to show benefit than controlled trials. In 19 uncontrolled studies, 17 popular therapies showed “benefit.” In 18 controlled studies, only 9 demonstrated benefit. An untrained reviewer of the research might base clinical practice on faulty con­clusions of uncontrolled trials.
Surfactant Therapy
In contrast to many proposed treatments, sur­factant therapy in premature infants has been well studied in RCTs.
ed the use of surfactant in treatment of RDS, includ­ing the optimal source and composition of surfactant and prophylactic versus rescue treatment. Morbidity (including pneumothorax, periventricular or intra­ventricular hemorrhage, BPD, and patent ductus arteriosus) and mortality rates in treatment and con­trol groups have been compared. Systematic reviews of surfactant therapy confirm the effect of surfactant therapy in reducing the risk of morbidity and mortal-
85,90
ity.
Although RCTs involving thousands of
newborns have clearly demonstrated the bene­fits of surfactant therapy, unanswered questions remain. One of these questions is if prophylactic
administration of surfactant to an infant judged to be at risk of developing RDS was better than early
4,5,46,48
Studies have evaluat-
selective use of surfactant to infants with established RDS. Early trials demonstrated a decreased risk of air leak and mortality with the prophylactic approach. However, recent RCTs that reflect current practice (i.e., greater utilization of maternal steroids and rou­tine postdelivery stabilization on continuous positive airway pressure [CPAP]) do not support these differ­ences and actually demonstrate less risk of chronic lung disease (CLD) or death when using early stabi­lization on CPAP with selective surfactant adminis­tration to infants requiring intubation
75,94
(Fig. 1.2).
Corticosteroid Therapy
Misuse of corticosteroids in perinatal med­icine illustrates the consequences of failure to practice evidence-based care. Many practi-
tioners initially declined to use antenatal steroids to promote maturation of the immature fetal lung and to prevent RDS despite strong supportive evidence, demonstrating a failure to use a proven therapy.
ANTENATAL CORTICOSTEROID
THERAPY: SINGLE COURSE
Antenatal administration of corticosteroids to preg-
nant women who threatened to deliver prematurely was first shown in 1972 to decrease the neonatal mortality rate and the incidence of RDS and intraventricular hemorrhage (IVH) in premature infants.57 In 1990, Crowley et al.25 used meta-anal­ysis to evaluate 12 RCTs of maternal corticosteroid administration involving more than 3000 women. The data showed that maternal corticosteroid treatment significantly reduced the risk for neo­natal mortality, RDS, and IVH. Sinclair,86 using a “cumulative meta-analysis” approach of randomized trials, clearly demonstrated that the aggregate evi­dence that was sufficient to show that this treatment reduces the incidence of RDS and neonatal death was available for almost 20 years before the use of antenatal corticosteroids was widely accepted by the medical community.
This led to the National Institutes of Health (NIH) consensus development conference statement on “Effects of Corticosteroids for Fetal Maturation on Perinatal Outcomes.”63 Antenatal corticosteroid treatment of women at risk for preterm delivery between 24 and 34 weeks of gestation has been shown to be effective and safe in enhancing fetal lung maturity and reducing neonatal mortality. Yet adoption by caretakers was inexplicably slow.
53
6
Favors prophylactic Favors selective
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Review: Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants Comparison: 2 Prophylactic surfactant vs. treatment of established respiratory distress in preterm infants less than 30 weeks' gestation Outcome: 1 Neonatal mortality
Study or subgroup
1 Studies without routine application of CPAP
Bevilacqua 1996
Bevilacqua 1997
Dunn 1991
Egberts 1993
Kendig 1991
Merritt 1991
Walti 1995
Subtotal (95% CI) 767 746 0.71 [ 0.58, 0.88 ]61.8%
Total events: 119 (Prophylactic), 161 (Selective) Heterogeneity: Chi Test for overall effect: Z 3.11 (P 0.0019)
2 Studies with routine application of CPAP
Dunn 2011
Support 2010
Subtotal (95% CI) 862 884 1.24 [ 0.97, 1.58 ]38.2%
Total events: 124 (Prophylactic), 102 (Selective) Heterogeneity: Chi Test for overall effect: Z 1.73 (P 0.083)
Total (95% CI) 1629 1630 0.91 [ 0.78, 1.07 ]100.0%
Total events: 243 (Prophylactic), 263 (Selective) Heterogeneity: Chi Test for overall effect: Z 1.11 (P 0.27) Test for subgroup difference: Chi
Prophylactic
n/N
28/136
9/49
9/62
8/75
23/235
27/76
15/134
??
8.27, df 6 (P 0.22); I?? 27%
10/209
114/653
??
0.02, df 1 (P 0.88); I?? 0.0%
??
18.64, df 8 (P 0.02); I?? 57%
Selective
n/N
46/132
9/44
8/60
14/72
40/244
21/72
23/122
8/221
94/663
??
11.24, df 1 (P 0.00); I?? 91%
Risk Ratio
M-H, Fixed, 95% CI
Weight
17.6%
3.6%
3.1%
5.4%
14.8%
8.2%
9.1%
2.9%
35.3%
Risk Ratio
M-H, Fixed, 95% CI
0.59 [ 0.39, 0.89 ]
0.90 [ 0.39, 2.06 ]
1.09 [ 0.45, 2.63 ]
0.55 [ 0.24, 1.23 ]
0.60 [ 0.37, 0.97 ]
1.22 [ 0.76, 1.95 ]
0.59 [ 0.33, 1.08 ]
1.32 [ 0.53, 3.28 ]
1.23 [ 0.96, 1.58 ]
FIGURE 1.2 Table showing effect of prophylactic versus selective surfactant administration on morbidity and mortality rates in preterm
infants. (From Rojas-Reyes X, Morley C, Soll R. Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2012;3:CD000510.)
ANTENATAL CORTICOSTEROID
THERAPY: REPEATED COURSES
At the same time, other practitioners adminis-
tered repeated doses despite lack of evidence of additional benefit and questions about safety, representing unproven use of a proven therapy. Repeated courses of antenatal cortico-
steroids have been shown in humans and animals to improve lung function and the quantity of pul­monary surfactant.
26,43
effects on lung structure, fetal somatic growth, and neonatal adrenocortical function, as well as poorly understood effects on blood pressure, carbohydrate homeostasis, and psychomotor development.
0.2
They may also have adverse
25,61
A
0.5 12 5
2000 NIH Consensus Development Conference found limited high-quality studies on the use of repeated courses of antenatal steroids.64 The con-
sensus statement discouraged routine use of repeated courses of antenatal corticosteroids.
Published preliminary reports of infants exposed to multiple doses of antenatal steroids reaching school age are emerging.9 A recent meta-analysis of infants who were exposed to more than one course of antenatal corticosteroids concluded that “although the short-term neonatal benefits of repeated cours­es of antenatal corticosteroids support their use, long-term benefits have not been demonstrated, and long-term adverse effects have not been ruled
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out. The adverse effect of repeated doses of ante­natal corticosteroids on birth weight and weight at early childhood follow-up is a concern. Caution should therefore be exercised to ensure that only those women who are at particularly high risk of very early preterm birth are offered treatment with repeated courses of antenatal corticosteroids.”27
The American College of Obstetricians and Gynecologists (ACOG) recommends a repeat course of antenatal steroids if the fetus is less than 34 weeks of gestation and the previous course of antenatal steroids was administered more than 14 days earlier.
POSTNATAL STEROID THERAPY
6
Postnatal glucocorticoids, administered to the infant after birth, have been widely used despite weak evidence of long-term benefit and suggestions of possible harm, illustrating use of an uncertain therapy.53 Despite early calls
for caution in the use of postnatal corticosteroids to decrease the risk for CLD and limit ventilator time, they were used liberally in the 1990s.
88,91
A number of years passed before RCTs of postnatal corticosteroid administration included long-term follow-up. Taken together,
these studies showed positive short-term effects on the lungs. Studies also showed increased blood pressure and blood glucose concentrations in the short term; increased incidence of septicemia and gastrointestinal perforation in the intermediate term; and with dexamethasone administered soon after birth, abnormal neurodevelopmental outcome, including cerebral palsy, in the long term.
3,31,46,54,91
An increased risk for septicemia should have been anticipated, because it was first identified in an RCT by Reese et al.74 over 50 years earlier.
In 2002, the American Academy of Pediatrics (Committee on Fetus and Newborn) and the Canadian Paediatric Society (Fetus and Newborn Committee) advised against the use of systemic dexamethasone and suggested that “outside the context of a RCT that include assessment of long­term development, the use of corticosteroids should be limited to exceptional clinical circumstances (e.g., an infant on maximal ventilator support and oxygen requirement).”2 A 2005 reanalysis of many of the same data by Doyle et al.31 suggests that rel­ative risks and benefits of postnatal corticosteroids vary with level of risk for BPD. When the risk for BPD or death is high, the risk for developmental
impairment from postnatal corticosteroids might be outweighed by benefit.
33, 36
Watterberg et al.
100
suggested that hydrocortisone might have the bene­fits of dexamethasone on the lungs without adverse neurologic effects. Following these statements, the exposure of at-risk premature infants decreased dramatically.
99,100
After reviewing the short-term and long-term effects of systemic and inhaled cor­ticosteroid use for the prevention and treatment of CLD/BPD in the VLBW infant, both the AAP and the Canadian Pediatric Society issued and reaffirmed position statements regarding the use of postnatal steroids.
14,15,52
QUALITATIVE RESEARCH EVALUATING EXPERIENCES IN THE NEONATAL INTENSIVE CARE UNIT
The contribution of qualitative research to EBP is evident when “best evidence from RCTs” may or may not work within the context of specific NICU environments. The
context can be quite variable and influenced by practitioners, staff, the unit leadership, and family influence within the unit. The implementation
of family-centered care in the NICU has shown promising outcomes, including mini­mizing parental stress related to the technolo­gy and complex care of a tiny, fragile preterm infant.59 An environment of family-centered care has also contributed in a positive way to the success of the implementation of clinical practice guidelines and evaluating outcomes.32 An additional area garnering focus in
recent qualitative research is discharge planning for VLBW infants and how teams have implemented EBP projects to address the issues identified as key to parental success once the infant is discharged to home. planning must include early integration of parents into the care team, CPR readiness of parents, how to deal with emergencies facing parents at home, and supportive infant care of the fragile infant for successful transition to home.
mation exists about a phenomenon or a deficiency is evident in the quality, depth, or detail of research in a specific area of clinical practice. Qualitative
research contributes to EBP in several
62,66,73,77
Findings suggest that discharge
Qualitative studies are useful when limited infor-
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areas: (1) describing patient needs and expe­riences; (2) providing the groundwork for instrument development and evaluation; and (3) elaborating on concepts relative to theory development.
60
Systematic reviews and meta-analyses are emerging in qualitative literature researching parental experiences in the NICU.
40,65
In neo­natology, qualitative studies provide in-depth views of parental and provider experiences within the NICU setting to humanize the health care of fragile infants. Parents of infants who require NICU
care begin an experience of parenthood in an unfamiliar and intimidating environment that results in delayed attachment
47,79,80
; high
levels of stress, including anxiety, depression, trauma symptoms, and isolation (both physi­cal and emotional) from their infant
16,38
; lack
of disclosure of their infant’s condition; and a lack of control.19 Mothers often experience feel-
ings of ambivalence, shame, guilt, and failure because the infant is in the NICU.79 Parents also experience the tension between exclusion and participation in their infant’s care.
101,102,103
In contrast, parents
describe factors that contribute to parental satisfaction in the NICU, including assurance, caring communication, provision of consis­tent information, education,24 environmental follow-up care, appropriate pain manage­ment,38 parental participation in care, and emotional, physical, and spiritual support.24
Conversely, health care professionals’ experiences of parental presence and participation in the NICU revealed similar findings to those described by par­ents: the need to develop a caring environment for parents to be present and take care of their child by guiding parents and giving parents permission to care for their child and the need for personnel training in the art of dealing with parents in crisis, identifying a balance between closeness and dis­tance, and dealing with parental worry.
102,103
Quality care is a major issue currently evaluating the delivery of health care services, yet little research has been conducted on what parents of premature infants perceive as quality nursing care. Price72 used
a qualitative approach to reveal the meaning of quality nursing care from parents’ perspec­tives and identified concepts inherent in the process of receiving quality nursing care. Four stages were identified: (1) maneuvering, (2) a process of knowing, (3) building relationships,
and (4) quality care. For parents, nontechnical aspects of care, such as comforting infants after painful procedures, were as important as the technical aspects of care. Another quali-
tative study revealed seven categories that influence changes in practice: (1) staffing issues, (2) consistency in practice, (3) the approval process for change, (4) a multidisciplinary approach to care, (5) frequency and consistency of communication, (6) rationale for change, and (7) the feedback process. Three catego­ries further delineate quality care: human resources, organizational structure, and communications.
103
Conversely, nurse descriptions of quality care included five core measure sets for evidence-based developmental care: (1) protected sleep, (2) pain and stress assessment and management, (3) developmen­tal activities of daily living, (4) family-centered care, and (5) providing a healing environment.28 Nurses also revealed their experiences in developmental care as “walking the line between the possible and ideal” illuminated through the five aspects of care: (1) being attentive to the infant-mother dyad, (2) developing parent and provider relationships (the body tells it all), (3) timing is everything, (4) work­ing in the quiet and caring, crowded and distress­ing space, (5) teamwork—demanding, smooth and helpful.45 Introducing developmental care in the NICU requires an understanding of expectations, timing, and relationships.
Another aspect currently investigated is the inte­gration of parents as members of the care team in the NICU (Family Integrated Care [FIC]). A recent multicenter, multinational, cluster randomized con­trolled trial that included 26 tertiary NICUs from Canada, Australia, and New Zealand demonstrated that infants assigned to FIC had improved infant weight gain, decreased parent stress and anxiety, and increased high frequency of exclusive breastmilk feeding at discharge66 (see Chapter 29).
SYSTEMATIC REVIEW IN PERINATAL CARE AND EVIDENCE-BASED PRACTICE
Evidence-based practice is the integration of the best possible research evidence with clinical exper­tise and patient needs. ature, such as those cited in the preceding sections, illustrate how the application of the principles of EBP offer a strong argument countering those who
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Examples from the liter-