Teenagers aged 16 to 18 are at increased risk for iron deficiency, exacerbated by losses with whole blood (WB) or double red blood cell (2RBC) donations. Required 56-day (WB) or 112-day (2RBC) interdonation intervals (IDIs) are too short for many to replace lost iron without supplements.METHODS:
Teenagers donating WB or 2RBCs at Vitalant, a national blood provider, had serum ferritin measured at their first and immediately subsequent successful donation from December 2016 to 2018. We modeled postindex log-ferritin as a function of IDI to estimate the shortest intervals that corresponded with 50% to 95% prevalence of adequate donor iron stores (ferritin ≥20 ng/mL female donors, ≥30 ng/mL male donors) at the subsequent donation.RESULTS:
Among 30 806 teenagers, 11.4% of female and 9.7% of male donors had inadequate iron stores at index donation. Overall, 92.6% had follow-up ferritin values within 13 months. Approximately 12 months after WB index donations, >60% of female and >80% of male donors had adequate iron stores (>50% and >70% after 2RBC donations). Follow-up–donation iron stores were highly dependent on index ferritin. Less than half of WB donors with low ferritin at index achieved adequate stores within 12 months. Achieving a ≥90% prevalence of adequate ferritin at 12 months required index values >50 ng/mL.CONCLUSIONS:
These findings suggest that postdonation low-dose iron supplements should be strongly encouraged in teenagers with borderline or low iron stores to permit donation without increased risk for symptoms of mild iron depletion. Increasing the minimum recommended IDI to allow time for replacing donation-related iron losses may be desirable for teenagers.
In 2013, New York introduced regulations mandating that hospitals develop pediatric-specific protocols for sepsis recognition and treatment.METHODS:
We used hospital discharge data from 2011 to 2015 to compare changes in pediatric sepsis outcomes in New York and 4 control states: Florida, Massachusetts, Maryland, and New Jersey. We examined the effect of the New York regulations on 30-day in-hospital mortality using a comparative interrupted time-series approach, controlling for patient and hospital characteristics and preregulation temporal trends.RESULTS:
We studied 9436 children admitted to 237 hospitals. Unadjusted pediatric sepsis mortality decreased in both New York (14.0% to 11.5%) and control states (14.4% to 11.2%). In the primary analysis, there was no significant effect of the regulations on mortality trends (differential quarterly change in mortality in New York compared with control states: –0.96%; 95% confidence interval [CI]: –1.95% to 0.02%; P = .06). However, in a prespecified sensitivity analysis excluding metropolitan New York hospitals that participated in earlier sepsis quality improvement, the regulations were associated with improved mortality trends (differential change: –2.08%; 95% CI: –3.79% to –0.37%; P = .02). The regulations were also associated with improved mortality trends in several prespecified subgroups, including previously healthy children (differential change: –1.36%; 95% CI: –2.62% to –0.09%; P = .04) and children not admitted through the emergency department (differential change: –2.42%; 95% CI: –4.24% to –0.61%; P = .01).CONCLUSIONS:
Implementation of statewide sepsis regulations was generally associated with improved mortality trends in New York State, particularly in prespecified subpopulations of patients, suggesting that the regulations were successful in affecting sepsis outcomes.
Benzodiazepines are commonly prescribed to treat anxiety disorders and have been associated with falls and fractures in older adults. It is unknown whether benzodiazepines increase fracture risk in youth. We examined whether youth with anxiety disorders initiating benzodiazepine treatment have an increased risk of fractures compared with youth initiating selective serotonin reuptake inhibitors (SSRIs).METHODS:
We used claims from commercially insured children (6–17 years) and young adults (18–24) with a recent anxiety disorder diagnosis, initiating benzodiazepines or SSRIs (2008–2016). Youth were followed until fracture, treatment discontinuation or switching, disenrollment, 3 months, or December 31, 2016. The primary end point was diagnostic codes for upper and lower limb fractures. Incident fracture rates, incident rate ratios (IRRs), and incident rate differences (IRDs) were estimated with propensity score inverse probability of treatment weighting.RESULTS:
The cohort included 120 715 children and 179 768 young adults. In children, crude fracture rates during treatment were 33.1 per 1000 person-years (PYs) for benzodiazepine initiators and 25.1 per 1000 PYs for SSRI initiators. Adjusted IRR and IRD were 1.53 (95% confidence interval [CI]: 0.94–2.50) and 13.4 per 1000 PYs. Risk was heightened in children initiating long-acting benzodiazepines versus SSRIs (adjusted IRR = 2.30 [95% CI: 1.08–4.91]). Fracture rates were lower in young adults, with minimal differences between treatments (adjusted IRR = 0.85 [95% CI: 0.57–1.27]; adjusted IRD = –1.3 per 1000 PYs).CONCLUSIONS:
An increased rate of fractures in children, but not young adults, with anxiety disorders initiating benzodiazepine treatment compared to SSRI treatment suggests a need for increased caution in the weeks after benzodiazepine initiation in children.
Child mobile device use is increasingly prevalent, but research is limited by parent-report survey methods that may not capture the complex ways devices are used. We aimed to implement mobile device sampling, a set of novel methods for objectively measuring child mobile device use.METHODS:
We recruited 346 English-speaking parents and guardians of children aged 3 to 5 years to take part in a prospective cohort study of child media use. All interactions with participants were through e-mail, online surveys, and mobile device sampling; we used a passive-sensing application (Chronicle) in Android devices and screenshots of the battery feature in iOS devices. Baseline data were analyzed to describe usage behaviors and compare sampling output with parent-reported duration of use.RESULTS:
The sample comprised 126 Android users (35 tablets, 91 smartphones) and 220 iOS users (143 tablets, 77 smartphones); 35.0% of children had their own device. The most commonly used applications were YouTube, YouTube Kids, Internet browser, quick search or Siri, and streaming video services. Average daily usage among the 121 children with their own device was 115.3 minutes/day (SD 115.1; range 0.20–632.5) and was similar between Android and iOS devices. Compared with mobile device sampling output, most parents underestimated (35.7%) or overestimated (34.8%) their child’s use.CONCLUSIONS:
Mobile device sampling is an unobtrusive and accurate method for assessing mobile device use. Parent-reported duration of mobile device use in young children has low accuracy, and use of objective measures is needed in future research.
More than 4 decades of research indicate that parenting interventions are effective at preventing and treating mental, emotional, and behavioral disorders in children and adolescents. Pediatric primary care is a viable setting for delivery of these interventions.OBJECTIVE:
Previous meta-analyses have shown that behavioral interventions in primary care can improve clinical outcomes, but few reviews have been focused specifically on the implementation of parenting interventions in primary care. We aimed to fill this gap.DATA SOURCES:
We reviewed 6532 unique peer-reviewed articles published in PubMed, the Cumulative Index to Nursing and Allied Health Literature, and PsycInfo.STUDY SELECTION:
Articles were included if at least part of the intervention was delivered in or through primary care; parenting was targeted; and child-specific mental, emotional, and behavioral health outcomes were reported.DATA EXTRACTION:
Articles were reviewed in Covidence by 2 trained coders, with a third coder arbitrating discrepancies.RESULTS:
In our review of 40 studies, most studies were coded as a primary. Few researchers collected implementation outcomes, particularly those at the service delivery system level.LIMITATIONS:
Including only published articles could have resulted in underrepresentation of implementation-related data.CONCLUSIONS:
Parenting interventions delivered and implemented with fidelity in pediatric primary care could result in positive and equitable impacts on mental, emotional, and behavioral health outcomes for both parents and their children. Future research on the implementation strategies that can support adoption and sustained delivery of parenting interventions in primary care is needed if the field is to achieve population-level impact.
Latinx adolescents are at risk for negative sexual health outcomes, and many interventions have been developed to reduce this risk.OBJECTIVE:
In this meta-analysis, we synthesized the literature on sexual health interventions for Latinx adolescents and examined intervention effects on 3 behavioral outcomes (abstinence, condom use, number of sex partners) and 3 psychological outcomes (safer sex knowledge, intentions, self-efficacy). Moderators of intervention success were explored.DATA SOURCES:
A systematic search of studies published through January 2019 was conducted by using PubMed, PsycINFO, and Cumulative Index to Nursing and Allied Health Literature databases.STUDY SELECTION:
All studies included a US-based sample of Latinx adolescents, evaluated sexual health intervention by using an experimental or quasiexperimental design, included a behavioral outcome, and were in English.DATA EXTRACTION:
Standardized mean difference (d) and 95% confidence intervals (CIs) were meta-analyzed by using random-effects models.RESULTS:
Effect sizes from 12 studies, sampling 4673 adolescents, were synthesized. Sexual health interventions improved abstinence (d = 0.15, 95% CI: 0.02 to 0.28), condom use (d = 0.44, 95% CI: 0.18 to 0.70), number of sex partners (d = –0.19, 95% CI: –0.37 to –0.001), and sexual health knowledge (d = 0.40, 95% CI: 0.10 to 0.70), compared with control conditions. Effects were consistent across a number of demographic and clinical characteristics, although culturally tailored interventions produced greater change in condom use than nontailored interventions.LIMITATIONS:
There was variation across studies in measures of sexual behavior, and some elements of individual study quality were unclear.CONCLUSIONS:
Sexual health interventions have a small but significant impact on improving safer sexual behavior among Latinx adolescents. Health educators should consider the importance of cultural tailoring to program success.
Respiratory syncytial virus (RSV) is a major cause of hospitalized acute respiratory illness (ARI) among young children. With RSV vaccines and immunoprophylaxis agents in clinical development, we sought to update estimates of US pediatric RSV hospitalization burden.METHODS:
Children <5 years old hospitalized for ARI were enrolled through active, prospective, population-based surveillance from November 1, 2015, to June 30, 2016, at 7 US pediatric hospital sites. Clinical information was obtained from parent interviews and medical records. Midturbinate nasal and throat flocked swabs were collected and tested for RSV by using molecular diagnostic assays at each site. We conducted descriptive analyses and calculated population-based rates of RSV-associated hospitalizations.RESULTS:
Among 2969 hospitalized children included in analyses, 1043 (35%) tested RSV-positive; 903 (87%) children who were RSV-positive were <2 years old, and 526 (50%) were <6 months old. RSV-associated hospitalization rates were 2.9 per 1000 children <5 years old and 14.7 per 1000 children <6 months old; the highest age-specific rate was observed in 1-month-old infants (25.1 per 1000). Most children who were infected with RSV (67%) had no underlying comorbid conditions and no history of preterm birth.CONCLUSIONS:
During the 2015–2016 season, RSV infection was associated with one-third of ARI hospitalizations in our study population of young children. Hospitalization rates were highest in infants <6 months. Most children who were RSV-positive had no history of prematurity or underlying medical conditions, suggesting that all young children could benefit from targeted interventions against RSV.
Neonatal-perinatal medicine (NPM) fellowship programs must provide adequate delivery room (DR) experience to ensure that physicians can independently provide neonatal resuscitation to very low birth weight (VLBW) infants. The availability of learning opportunities is unknown.METHODS:
The number of VLBW (≤1500 g) and extremely low birth weight (ELBW) (<1000 g) deliveries, uses of continuous positive airway pressure, intubation, chest compressions, and epinephrine over 3 years at accredited civilian NPM fellowship program delivery hospitals were determined from the Vermont Oxford Network from 2012 to 2017. Using Poisson distributions, we estimated the expected probabilities of fellows experiencing a given number of cases over 3 years at each program.RESULTS:
Of the 94 NPM fellowships, 86 programs with 115 delivery hospitals and 62 699 VLBW deliveries (28 703 ELBW) were included. During a 3-year fellowship, the mean number of deliveries per fellow ranged from 14 to 214 (median: 60) for VLBWs and 7 to 107 (median: 27) for ELBWs. One-half of fellows were expected to see ≤23 ELBW deliveries and 52 VLBW deliveries, 24 instances of continuous positive airway pressure, 23 intubations, 2 instances of chest compressions, and 1 treatment with epinephrine.CONCLUSIONS:
The number of opportunities available to fellows for managing VLBW and ELBW infants in the DR is highly variable among programs. Fellows’ exposure to key, high-risk DR procedures such as cardiopulmonary resuscitation is low at all programs. Fellowship programs should track fellow exposure to neonatal resuscitations in the DR and integrate supplemental learning opportunities. Given the low numbers, the number of new and existing NPM programs should be considered.
Clinicians in the United States today regularly face dilemmas about health disparities. Many patients and families cannot afford the medical care that doctors recommend. These problems are most stark when the medical care that is needed is lifesaving and expensive and involves scarce resources. Transplants are the best example of this. The most ethically disturbing situations occur when an undocumented immigrant child needs a transplant. We present such a case and analyze the ethical, legal, and policy issues that arise.
Patients are surviving decades after congenital heart surgery (CHS), raising the importance of postoperative quality of life as an outcome measure. We determined the long-term social outcomes after CHS performed during childhood.METHODS:
Between 1953 and 2009, 10 635 patients underwent surgery for congenital heart defects at <15 years of age in Finland. We obtained 4 control subjects per patient, matched by age, sex, birth time, and hospital district, from Statistics Finland, which also provided data on the highest education level, employment status, marital status, and progeny for both patients and control subjects. We included patients who were alive and ≥18 years of age at the end of the follow-up on December 31, 2017.RESULTS:
A total of 7308 patients met inclusion criteria. Patients had on average similar high school or vocational education rates as the general population but lower undergraduate or higher education rates (female patients: risk ratio [RR] 0.8 [95% confidence interval (CI) 0.8–0.9]; male patients: RR 0.8 [95% CI 0.7–0.9]). Patients were less likely to be married or have progeny compared with the general population. The rate of employment was significantly lower (female patients: RR 0.8 [95% CI 0.8–0.9]; male patients: RR 0.8 [95% CI 0.8–0.9]) and the rate of retirement (female patients: RR 2.1 [95% CI 2.0–2.3]; male patients RR 3.1 [95% CI 2.9–3.5]) significantly higher among patients.CONCLUSIONS:
Patients who undergo CHS at childhood age are, on average, more disadvantaged from both an educational and professional standpoint compared with the general population, regardless of the severity of the defect.
Obtaining recent estimates of the prevalence of suicide-related outcomes across adolescence and its associated mental health problems (MHPs) is important for clinical practice. We estimated the prevalence of suicide-related outcomes at ages 13, 15, 17, and 20 years (2011–2018) in a contemporary population-based cohort and documented associations with MHPs throughout adolescence.METHODS:
Data came from 1618 participants in the Québec Longitudinal Study of Child Development. Internalizing (depression and anxiety) and externalizing (oppositional/defiance, conduct issues, and attention deficit and/or hyperactivity) MHPs were assessed with validated questionnaires. Outcomes were self-reported past-year passive and serious suicidal ideation and suicide attempt.RESULTS:
Lifetime prevalence of passive suicidal ideation (13–17 years old), serious suicidal ideation, and suicide attempt (13–20 years old) were 22.2%, 9.8%, and 6.7%, respectively. Prevalence was twice as high for females as for males. Overall, rates of passive (15–17 years old; 11.8%–18.4%) and serious ideation (13–20 years old; 3.3%–9.5%) increased over time but were stable for attempt (13–20 years old; 3.5%–3.8%). In univariable analyses, all MHPs were associated with suicide-related outcomes at all ages (risk rate ratio range: 2.57–3.10 [passive ideation] and 2.10–4.36 [suicide attempt]), and associations were similar for male and female participants (sex interaction P > .05). Magnitude of associations were generally stronger for more severe suicide-related outcomes (passive ideation < serious ideation < attempt). In multivariable analyses, internalizing problems were associated with suicidal ideation, whereas both depressive and conduct symptoms were associated with attempt.CONCLUSIONS:
Suicidal ideation and attempt were common, especially for females and youth presenting with depressive and conduct problem symptoms. Clinicians should systematically assess suicidal risk in teenagers, especially in those presenting with MHPs.
The World Health Organization has designated vaccine hesitancy as 1 of the 10 leading threats to global health, yet there is limited current national data on prevalence of hesitancy among US parents. Among a nationally representative sample of US parents, we aimed to (1) assess and compare prevalence of hesitancy and factors driving hesitancy for routine childhood and influenza vaccination and (2) examine associations between sociodemographic characteristics and hesitancy for routine childhood or influenza vaccination.METHODS:
In February 2019, we surveyed families with children using the largest online panel generating representative US samples. After weighting, we assessed hesitancy using a modified 5-point Vaccine Hesitancy Scale and labeled parents as hesitant if they scored >3.RESULTS:
A total of 2176 of 4445 parents sampled completed the survey (response rate 49%). Hesitancy prevalence was 6.1% for routine childhood and 25.8% for influenza vaccines; 12% strongly and 27% somewhat agreed they had concerns about serious side effects of both routine childhood and influenza vaccines. A total of 70% strongly agreed that routine childhood vaccines are effective versus 26% for influenza vaccine (P < .001). In multivariable models, an educational level lower than a bachelor’s degree and household income <400% of the federal poverty level predicted hesitancy about both routine childhood and influenza vaccines.CONCLUSIONS:
Almost 1 in 15 US parents are hesitant about routine childhood vaccines, whereas >1 in 4 are hesitant about influenza vaccine. Furthermore, 1 in 8 parents are concerned about vaccine safety for both routine childhood and influenza vaccines, and only 1 in 4 believe influenza vaccine is effective. Vaccine hesitancy, particularly for influenza vaccine, is prevalent in the United States.
To examine trends in survival without major morbidity and its individual components among very low birth weight infants across California and assess remaining gaps that may be opportune targets for improvement efforts.METHODS:
The study population included infants born between 2008 and 2017 with birth weights of 401 to 1500 g or a gestational age of 22 to 29 weeks. Risk-adjusted trends of survival without major morbidity and its individual components were analyzed. Survival without major morbidity was defined as the absence of death during birth hospitalization, chronic lung disease, severe peri-intraventricular hemorrhage, nosocomial infection, necrotizing enterocolitis, severe retinopathy of prematurity or related surgery, and cystic periventricular leukomalacia. Variations in adjusted rates and/or interquartile ranges were examined. To assess opportunities for additional improvement, all hospitals were reassigned to perform as if in the top quartile, and recalculation of predicted numbers were used to estimate potential benefit.RESULTS:
In this cohort of 49 333 infants across 142 hospitals, survival without major morbidity consistently increased from 62.2% to 66.9% from 2008 to 2017. Network variation decreased, with interquartile ranges decreasing from 21.1% to 19.2%. The largest improvements were seen for necrotizing enterocolitis and nosocomial infection. Bronchopulmonary dysplasia rates did not change significantly. Over the final 3 years, if all hospitals performed as well as the top quartile, an additional 621 infants per year would have survived without major morbidity, accounting for an additional 6.6% annual improvement.CONCLUSIONS:
Although trends are promising, bronchopulmonary dysplasia remains a common and persistent major morbidity, remaining a target for continued quality-improvement efforts.
To test associations between onset of formal child care (in infancy or as a toddler), high school graduation, and employment earnings from ages 18 to 35 years.METHODS:
A 30-year prospective cohort follow-up study, with linkage to government administrative databases (N =3020). Exposure included formal child care, if any, by accredited caregivers in centers or residential settings at ages 6 months and 1, 1.5, 2, 3, and 4 years. A propensity score analysis was conducted to control for social selection bias.RESULTS:
Of 2905 participants with data on child care use, 59.4% of male participants and 78.5% of female participants completed high school by age 22 to 23. Mean income at last follow-up (n = 2860) was $47 000 (Canadian dollars) (SD = 37 700) and $32 500 (SD = 26 800), respectively. Using group-based trajectory modeling, we identified 3 groups: formal child care onset in infancy (~6 months), formal child care onset as a toddler (after 2.5 years), and never exposed. After propensity score weighting, boys with child care started in infancy had greater odds of graduating than those never exposed (odds ratio [OR] 1.39; 95% confidence interval [CI]: 1.18–1.63; P < .001). Boys attending child care had reduced odds of low income as young adults (infant onset: OR 0.60 [95% CI: 0.46–0.84; P < .001]; toddler onset: OR 0.63 [95% CI: 0.45–0.82; P < .001]). Girls’ graduation rates and incomes revealed no significant association with child care attendance.CONCLUSIONS:
For boys, formal child care was associated with higher high school completion rates and reduced risk of adult poverty. Benefits for boys may therefore extend beyond school readiness, academic performance, and parental workforce participation.
Insights from behavioral economics suggests that the effectiveness of health messages depends on how a message is framed. Parent preferences for smoking cessation messaging has not been studied in pediatrics, warranting further exploration to maximize benefit. We sought to assess parents’ perceptions regarding the relative importance of distinct message framings to promote their smoking cessation.METHODS:
We conducted a cross-sectional discrete choice experiment in which parent smokers rated the relative importance of 26 messages designed to encourage them to begin cessation treatment. Messages varied on who was featured (child, parent, or family), whether the message was gain or loss framed, and what outcome was included (general health, cancer, respiratory illnesses, child becoming a smoker, or financial impact). The participants were 180 parent smokers attending primary care visits with their children at 4 diverse pediatric sites. The main outcome was the importance of smoking cessation messages based on who was featured, gain or loss framing, and the outcome emphasized.RESULTS:
Parent smokers highly prioritized cessation messages emphasizing the impact of quitting smoking on their child versus parent or family. Messages focusing on respiratory illness, cancer, or general health outcomes consistently ranked highest, whereas messages focused on the financial benefits of quitting ranked lowest. Gain versus loss framing did not meaningfully influence rankings.CONCLUSIONS:
Parent smokers identified smoking cessation messages that emphasized the impact on their child, with outcomes focused on respiratory health, cancer, or general health, as most important. The clinical impact of these messages should be tested in future research.
Increased electronic cigarette (e-cigarette) use among young people is often attributed to industry marketing practices; however, the effectiveness of regulations that limit e-cigarette advertising and promotions has yet to be examined. New federal legislation that liberalized the Canadian e-cigarette market in May 2018, along with differences in provincial regulations, provides an opportunity to examine the impact of regulatory restrictions on e-cigarette marketing.METHODS:
Repeat cross-sectional surveys of 12 004 16- to 19-year-olds in Canada, completed online in 2017, 2018, and 2019. Logistic regression models were used to examine differences over time in exposure to e-cigarette marketing and e-cigarette use, including between provinces with differing strengths of marketing restrictions.RESULTS:
The percentage of youth surveyed who reported noticing e-cigarette promotions often or very often approximately doubled between 2017 and 2019 (13.6% vs 26.0%; adjusted odds ratio [AOR] = 2.24, 95% confidence interval [CI] = 1.97–2.56). Overall exposure to marketing was generally more prevalent in provinces with fewer regulatory restrictions. Respondents who reported noticing marketing often or very often were more likely to report vaping in the past 30 days (AOR = 1.41, 95% CI = 1.23–1.62), past week (AOR = 1.44, 95% CI = 1.22–1.70), and ≥20 days in the past month (AOR = 1.42, 95% CI = 1.11–1.81, P = .005). Provinces with low restrictions on marketing had higher prevalence of vaping in the past 30 days (AOR = 1.50, 95% CI = 1.25–1.80, P < .001), and in the past week (AOR = 1.65, 95% CI = 1.33–2.05, P < .001).CONCLUSIONS:
Exposure to marketing and the prevalence of vaping increased among Canadian youth after the liberalization of the e-cigarette market in 2018. Comprehensive provincial restrictions on e-cigarette marketing were associated with lower levels of exposure to marketing and lower prevalence of e-cigarette use.
In the United States in 2019, there was an outbreak of electronic cigarette, or vaping, product use–associated lung injury (EVALI). The manifestations of EVALI in adolescents are not well characterized. We describe the diagnosis, evaluation, and management of EVALI in adolescents hospitalized at a tertiary care, university-affiliated children’s hospital.METHODS:
A multidisciplinary committee developed an EVALI algorithm on the basis of guidelines from the Centers for Disease Control and Prevention. A retrospective chart review was conducted on patients diagnosed with EVALI. Descriptive analyses included sociodemographic characteristics, clinical presentation, laboratory and imaging results, pulmonary function testing, oxygen requirements, and clinic follow-up.RESULTS:
Thirteen hospitalized adolescents were diagnosed with confirmed or probable EVALI. The majority were female (54%) with a mean age of 15.9 years. Sixty-nine percent of patients presented with respiratory symptoms, whereas gastrointestinal symptoms were prominent in 85% of patients. Vaping -9-tetrahydrocannabinol was reported in 92% of patients, and vaping nicotine was reported in 62% of patients. All had bilateral ground-glass opacities on the chest computed tomography (CT) scan. Treatment with glucocorticoids led to clinical improvement in 11 of 12 patients. Treatment with glucocorticoids led to improvement in both forced expiratory volume in 1 second and forced vital capacity (P < .05). Four patients required home oxygen on the basis of 6-minute walk test results.CONCLUSIONS:
Diagnosis of EVALI should be suspected on the basis of vaping history and clinical presentation. Glucocorticoid treatment led to an improvement in symptoms and lung function. The 6-minute walk test may help determine oxygen needs at discharge.
As rates of neonatal opioid withdrawal are increasing, the need for research to evaluate new treatments is growing. Large heterogeneity exists in health outcomes reported in current literature. Our objective is to develop an evidence-informed and consensus-based core outcome set in neonatal opioid withdrawal syndrome (NOWS-COS) for use in studies and clinical practice.METHODS:
An international multidisciplinary steering committee was established. A systematic review and a 3-round Delphi was performed with open-ended and score-based assessments of the importance of each outcome to inform clinical management of neonatal opioid withdrawal. Interviews were conducted with parents and/or caregivers on outcome importance. Finally, a consensus meeting with diverse stakeholders was held to review all data from all sources and establish a core set of outcomes with definitions.RESULTS:
The NOWS-COS was informed by 47 published studies, 41 Delphi participants, and 6 parent interviews. There were 63 outcomes evaluated. Final core outcomes include (1) pharmacologic treatment, (2) total dose of opioid treatment, (3) duration of treatment, (4) adjuvant therapy, (5) feeding difficulties, (6) consolability, (7) time to adequate symptom control, (8) parent-infant bonding, (9) duration of time the neonate spent in the hospital, (10) breastfeeding, (11) weight gain at hospital discharge, (12) readmission to hospital for withdrawal, and (13) neurodevelopment.CONCLUSIONS:
We developed an evidence-informed and consensus-based core outcome set. Implementation of this core outcome set will reduce heterogeneity between studies and facilitate evidence-based decision-making. Future research will disseminate all the findings and pilot test the validity of the NOWS-COS in additional countries and populations to increase generalizability and impact.