Content area
Importance
Vigilant clinical assessment is the key to preventing complications, including death, in infants at risk of neonatal withdrawal syndrome. The eat, sleep and console (ESC) is proposed as an alternative to usual care with Finnegan’s Neonatal Abstinence Scoring System (FNASS), but whether ESC improves infant outcomes is uncertain.
Objective
To conduct a meta-analysis and systematic review of outcomes of studies comparing ESC to FNASS.
Data sources
PubMed, Embase, CINAHL and Cochrane were searched. There was no date restriction.
Study selection
Published data from observational studies published in English were included. Randomised controlled trials, reviews and abstracts were excluded. Data was required to be converted to mean and SD to be included.
Data extraction and synthesis
Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines were used, and data were independently extracted by multiple observers. Data was pooled using a random-effects model.
Main outcome and measures
Length of stay (LOS) in days, number of days medicated and proportion of infants medicated were the primary outcomes assessed. It was hypothesised prior to data collection that ESC would be associated with shorter LOS and a lower proportion of infants medicated, given key differences in infant assessment compared with the FNASS.
Results
12 studies, all from the USA, were published between 2018 and 2024. 10 quality improvement studies and two cohort studies compared ESC (n=1877) with historical controls using FNASS (n=2199). ESC decreased hospitalisation days (MD −4.11 days, 95% CI −6.04 to −2.19 days; p<0.0001; I2=95%; 10 studies; 3703 participants) and the proportion treated with withdrawal medications (OR 0.36, 95% CI 0.22 to 0.60; I2=89%; RD −0.22; 95% CI −0.34 to −0.10; p<0.0001; I2=93%; 12 studies; 4076 participants). One study assessed physical health up to 1 week after discharge (n=1), three assessed weight loss (n=3) and one assessed cost (n=1).
Conclusions and relevance
The majority of evidence for a reduction in hospitalisation and need for withdrawal medication with ESC compared with FNASS is derived from quality improvement and cohort studies with almost no health information beyond 1 week after discharge. High-quality trials incorporating physiological measurements of infant stress and longer-term outcomes are needed.
Review prospective registration
Full text
Correspondence to Dr Ju-Lee Oei; [email protected]
WHAT IS ALREADY KNOWN ON THIS TOPIC
For infants with neonatal abstinence syndrome, the eat, sleep and console (ESC) model is an alternative treatment to the usual Finnegan Neonatal Abstinence Scoring System (FNASS). The ESC has been implemented in neonatal units worldwide, despite most of its data originating from largely observational studies. It is unclear how ESC compares to FNASS in short-term and long-term outcomes.
WHAT THIS STUDY ADDS
This systematic review and meta-analysis of observational data found that 12 American studies demonstrated shorter lengths of stay, shorter total time medicated and lower medication rate with ESC compared with FNASS. These were cohort and quality improvement studies with significant heterogeneity, small sample sizes and methodological differences.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
While this review has demonstrated ESC is associated with shorter length of stay and lower medication rates, these must be interpreted in the context of significant heterogeneity and small sample sizes. Large and well-designed studies, including countries outside of the USA, are required before lasting conclusions about the benefits of ESC versus FNASS are made.
Introduction
Close clinical observation to inform prompt and appropriate treatment is key to preventing serious complications in sick patients. In infants with neonatal abstinence syndrome (NAS), suboptimally treated withdrawal leads to serious consequences, including death.1 In 1975, the Finnegan Neonatal Abstinence Scoring System (FNASS) was proposed as a tool to rate the severity of narcotic withdrawal in newborn infants.2 In the initial cohort of 55 infants, a detailed and standardised assessment with the FNASS was found to significantly reduce the need for (54% vs 70%) and duration of (8 vs 6 days) pharmacological treatment as well as length of hospitalisation (21 vs 5 days).2
The FNASS is now the most commonly used clinical tool for assessing and treating infants at risk of NAS, but it has limitations.3 Originally developed as a research tool,2 the FNASS is considered to be a complex (21–30 items depending on the version) and subjective tool that is prone to errors.4 5 It has never been validated in many populations in which it is currently used, including preterm infants, infants exposed to non-opioid drugs or even those with iatrogenic withdrawal from postnatal drug exposure.6–9
In 2017, Grossman and colleagues devised a novel approach to NAS treatment in response to the United States’ opioid crisis and increased number of NAS infants. The eat, sleep and console (ESC) approach was based on an infant’s primary functional needs: to be able to feed, sleep and be soothed.6 NAS medications were administered only if the infant failed to meet these criteria and with agreement between clinicians and the infant’s caregiver. Quality improvement (QI) studies have shown significantly decreased length of hospitalisation,7–11 pharmacological treatment6 8 11 and cumulative medication doses with ESC compared with FNASS.7–10 Young et al completed the largest (n=1305, 26 US sites) cluster randomised step-wedged study comparing FNASS to ESC and found ESC significantly reduced hospitalisation (8.2 vs 14.9 days) without increasing rehospitalisation until 3 months of age.12 The ESC is also considered a more acceptable assessment tool than FNASS by parents,13 clinicians10 and even policymakers.14
The USA is now rapidly losing equipoise for ESC despite a lack of evidence of its safety or efficacy on infants beyond early infancy or in withdrawal from non-opioid drugs. The ESC is only validated for opioid-exposed infants15 but continues to be implemented for non-opioid exposed infants in non-controlled cohort studies.16 The longest follow-up period for ESC that is published in the current literature is only 3 months of age.12 While ESC has been implemented in published studies with positive short-term outcomes, a scoping review of 34 implementation studies found that barriers and facilitators of ESC were poorly reported. Additionally, implementation outcomes, like acceptability, feasibility, cost and sustainability, were minimally explored, subsequently limiting understanding of how and why ESC can work across institutions.17
Before the ESC is adopted into practice, there is an urgent need to systematically review existing information on ESC to determine its limitations and to guide practice and research. In this study, we examined studies from centres comparing ESC to FNASS to determine the impact on infant health, hospitalisation and longer-term outcomes such as safety. Given the high prevalence of QI studies examining ESC versus FNASS, the decision was made to use observational data, including cohort studies. We hypothesised that ESC would be associated with improved short-term outcomes, including decreased need for withdrawal medications and hospitalisation, but that evidence would be lacking for longer-term outcomes, for example, beyond hospital discharge and for exposures to non-opioid drugs.
Methods
This systematic review and meta-analysis were conducted and reported according to the meta-analysis of observational studies in epidemiology (online supplemental eTable 1) and Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.18 19 A priori protocol was created and registered on PROSPERO (CRD42024532169).
Types of studies
Only published observational studies that compared outcomes of infants exposed to prenatal drugs of dependency who were assessed with the ESC and the FNASS were included. Excluded studies included randomised controlled trials (RCTs), case series and studies not published in English. Randomised trials were not included to limit potential heterogeneity within the results.
Types of participants
Infants with a diagnosis of NAS were included in the study. Those infants that were preterm (<35 weeks gestation) or receiving opioids for reasons other than NAS were excluded.
Types of interventions
The intervention group were infants assessed and managed via the ESC. The control group were infants assessed and managed via the FNASS.
Types of outcome measures
Primary outcomes
LOS was calculated as days and required mean and SD or data that could be converted to mean and SD (ie, median and IQR). The length of time medicated was calculated in days, with the same parameters as above. The proportion of medicated infants was calculated as percentage.
Secondary outcomes
Secondary outcomes included the cost of intervention (USD$) pre-ESC and post-ESC. Weight loss was calculated as the percentage lost of birth weight following ESC. Rehospitalisation rates for any reason were calculated as the percentage preintervention and postintervention.
Search methods
Electronic databases, including PubMed, Cumulated Index to Nursing and Allied Health Literature (CINAHL), Cochrane and Excerpta Medica database (Embase), were searched. Hand searching was conducted for references of included studies and those of previous reviews. Backward searching for other articles by the same authors was used, especially for longitudinal cohort studies. A search strategy (online supplemental appendix 1) using the terms ‘prenatal exposure’, ‘opioid’, ‘methadone’, ‘heroin’, ‘neonatal abstinence syndrome’, ‘withdrawal’, ‘Eat Sleep Console’ and ‘Finnegan Neonatal Abstinence Severity Score’ was included. There was no publication date restriction. Articles had to be written in English. The initial search began on 1 April 2024 and continued concurrently with data extraction until 30 June 2024.
Data collection and analysis
Selection of studies
Two authors (ZW and JC) assessed eligibility by title and abstract screening. Eligible articles then underwent a full manuscript review by two authors. Studies were stored and screened in Covidence, a web-based collaboration software platform to streamline literature reviews.20 Study authors were contacted for further information. Disagreements regarding inclusion criteria were solved through discussion and, if required, adjudicated by a senior author (JO). The study flow diagram is shown in figure 1.
Data extraction and management
The extracted study characteristics included the authors, date of publication, country of study origin, study period, number of participants and primary outcomes and outcome data. Outcome data included the average LOS in the hospital in days and the proportion of infants requiring pharmacotherapy. Rehospitalisations related to NAS, cost of hospitalisation and duration of pharmacotherapy were also extracted. Data were extracted and stored in Covidence and Excel.20 21
Assessment of risk of bias in included studies
Two authors (ZW and JC) independently assessed the quality of the QI studies using the Ottawa Quality Improvement Framework (OQIF) and Newcastle Ottawa Scale (NOS) for cohort studies. OQIF results were averaged, and disagreements regarding NOS were solved through discussion and adjudicated by a senior author (MEA-L). The OQIF assesses QI studies based on five key principles: understanding the problem, understanding the interventions trialled, iterative improvement cycles, changes as a result, hard-wiring, scaling and spreading.22 The NOS is used in non-randomised studies based on study group selection, group comparability and ascertainment of the outcome of interest.23
Measures of treatment effect
The main outcome measures were mean differences (MD) and CI, calculated from the means and SD for continuous data. The standardised MD (SMD) was reported for cost using Hedges’ adjusted g. In assessing treatment effects for dichotomous data, we reported the OR or the risk difference (RD) via the Mantel-Haenszel methods, along with the 95% CI. Data were pooled using the inverse-variance method and random-effects model. Standard meta-analytic procedures were conducted with the Cochrane Collaboration Review Manager Software (RevMan V.5.4).24
Unit of analysis issues
When means and SD were not available, data were converted via Hozo’s method.25 If studies did not include key data points for conversion, they were excluded for that particular outcome.
Assessment of heterogeneity
I2 statistic was used to describe the variation between studies due to heterogeneity rather than chance. The grading system for heterogeneity was as follows: none (<25%), low (25%–49%), moderate (50%–74%) and high (≥75%).26 Using the χ2 test, p<0.1 was regarded as significant.
Assessment of publication bias
Publication bias and funnel plots were assessed and generated using Meta-Essentials.27 Publication bias was also assessed visually with funnel plot asymmetry and formally with Egger’s test. Egger’s test examines the association between effect size and SE and was used for outcomes with 10 or more studies.28
Data synthesis
Structured reporting of the effects of both primary and secondary outcomes was performed in reference to forest plots generated via RevMan V.5.4.
Subgroup and sensitivity analysis
Subgroup and sensitivity analyses were initially planned, but due to limitations in data collection, these could not be performed.
Results
Results of the search
A total of 236 records were found following the initial search criteria. 78 duplicates were removed, with 158 studies proceeding to title and abstract screening. 130 of these studies were deemed ineligible due to irrelevant content, and 25 texts continued to full-text review. 15 studies were excluded. Reasons for exclusion included one study design not matching criteria29; three with intervention not matching criteria7 30 31; five without enough data convertible to study measures15 32–35, and six being conference or poster abstracts.36–41 This left 12 studies for data extraction (figure 1).
Included studies
These 12 studies were published in the USA between 2018 and 2024. The type of substance exposure, sample size and clinical setting varied between studies. All studies compared the ESC (n=1877) with preintervention controls using the FNASS (n=2199). Most studies were QI in their design,8–11 42–47 with two retrospective cohort studies.48 49 Only one study followed up on infants, 1 week postdischarge.44 A summary of the study characteristics is provided in online supplemental eTable 2.
Risk of bias in included studies
The mean quality score of the 10 QI studies was 3.45/5 or mid-range quality (table 1a). The NOS for the two cohort studies was fair for Chyi, 2024 and good for Singh, 2024 when converted to Agency for Healthcare Research and Quality standards (table 1b).48 49
Table 1(a) Study quality: The Ottawa Quality Improvement Framework summary for quality improvement studies. (b) Study quality: Newcastle-Ottawa Scale quality assessment summary for observational studies
| (a) | ||||||||
| Study | Understood the problem | Understood the interventions trialled | Iterative improvement cycles | Changes as a result | Hard-wiring | Scaling and spreading | Mean Score | Total |
| Wachman et al11 (2018) | 5 | 5 | 4 | 4.5 | 3 | 2 | 3.9 | 23.5 |
| Blount et al8 (2019) | 4.5 | 4.5 | 1.5 | 3 | 3 | 2 | 3.05 | 18.5 |
| Dodds et al9 (2019) | 5 | 4.5 | 3.5 | 3.5 | 3.5 | 3.5 | 3.95 | 23.5 |
| Parlaman et al10 (2019) | 5 | 5 | 3 | 3.5 | 3 | 4 | 3.9 | 23.5 |
| Wachman45 (2020) | 5 | 5 | 3 | 2.5 | 2 | 2.5 | 3.3 | 20 |
| Hein et al46 (2021) | 5 | 5 | 4 | 4 | 2 | 2.5 | 3.7 | 22.5 |
| Ryan et al47 (2021) | 5 | 4.5 | 1.5 | 3 | 1.5 | 2 | 2.9 | 17.5 |
| Ponder et al44 (2021) | 5 | 5 | 4 | 4.5 | 2.5 | 2.5 | 4.3 | 23.5 |
| Haaland et al43 (2023) | 5 | 5 | 1 | 2.5 | 2 | 3.5 | 2.85 | 19 |
| Amin et al42 (2023) | 5 | 4.5 | 1 | 2.5 | 1.5 | 1 | 2.6 | 15.5 |
| (b) | ||||||||||
| Study | Selection | Comparability | Outcomes | Stars per category (4/1/3) | Agency for Healthcare Research and Quality (AHRQ) score | |||||
| Representativeness of the exposed cohort | Selection of the non-exposed cohort | Ascertainment of exposure | Demonstration that outcome(s) were not present at start of study | Comparability of cohorts on the basis of the design or analysis | Assessment of outcome | Was follow-up long enough for outcomes to occur | Adequacy of follow-up of cohorts | |||
| Chyi et al48 (2023) | B | A | A* | A* | A* | B* | A* | A* | 2/1/3 | Fair |
| Singh49 (2024) | A | A* | A* | B | A* | B* | A* | B* | 2/1/3 | Good |
The Ottawa Quality Improvement Framework is rated on a Likert scale from 1 to 5, where 1=totally unclear (or unclear evidence) and 5=fully clear (or full evidence).
*The Newcastle-Ottawa Scale awards based on adherence to criteria within the guideline. A study can be awarded a maximum of one star for each numbered item within the Selection category. A maximum of two stars can be awared for the Comparability Category. These stars can be convered to Agency for Healthcare Research and Quality standards of good/fair/poor quality: Good quality: 3 or 4 stars in selection domain AND 1 or 2 stars in comparability domain AND 2 or 3 stars in outcome/exposure domain, Fair quality: 2 stars in selection domain AND 1 or 2 stars in comparability domain AND 2 or 3 stars in outcome/exposure domain, Poor quality: 0 or 1 star in selection domain OR 0 stars in comparability domain OR 0 or 1 stars in outcome/exposure domain.
Effects of interventions
Length of stay
10 studies found that ESC was associated with a significantly decreased length of hospitalisation compared with FNASS by −4.11 days (MD −4.11 days, 95% CI −6.04 to −2.19 days; p<0.0001; I2=95%; 10 studies; 3703 participants, random-effects analysis, figure 2a).8 9 11 42–45 47–49 However, there was significant heterogeneity among the included studies. There was evidence of funnel plot asymmetry that was statistically significant (intercept −12.70, 95% CI −18.85 to −6.55; p=0.002) using funnel plot inspection and Egger’s test, suggesting publication bias (figure 2b).
Figure 2. Forest (a) and funnel plot (b) for the effects of ESC compared with FNASS on the length of stay. Egger’s test p=0.002. ESC, eat, sleep and console; FNASS, Finnegan's Neonatal Abstinence Scoring System; CES, Combined effect size.
Length of time medicated
Seven studies assessed the length of time medicated, with an MD of −6.32 days in the ESC group when compared with FNASS (MD −6.32 days; 95% CI −9.13 to −3.51 days; p<0.0001; I2=97%; seven studies; 3450 participants, random-effects analysis, figure 3).11 42 44 45 47–49
Figure 3. Forest (a) and funnel plot (b) for the effects of ESC compared with FNASS on the length of time medicated. ESC, eat, sleep and console; FNASS, Finnegan's Neonatal Abstinence Scoring System;; CES, Combined effect size.
Proportion medicated
The proportion of infants medicated was significantly reduced in the ESC intervention compared with the FNASS in 12 studies (OR 0.36, 95% CI 0.22 to 0.60; I2=89%; RD −0.22; 95% CI −0.34 to −0.10; p<0.0001; I2=93%; 12 studies; 4076 participants, random-effects analysis, figure 4a).8–11 42–49 The heterogeneity was high for this outcome. There was asymmetry noted on the funnel plot; however, this was not statistically significant (intercept 5.01, 95% CI −2.72 to 12.74; p=0.583) using Egger’s test (figure 4b).
Figure 4. Forest (a) and funnel plot (b) for the effects of ESC compared with FNASS on the proportion of medicated infants. OR calculated via the Mantel-Haenszel method. Egger’s test p-value=0.184. ESC, eat, sleep and console; FNASS, Finnegan's Neonatal Abstinence Scoring System; CES, Combined effect size.
Rehospitalisation
11 studies reported rates of rehospitalisation for infants treated with ESC versus FNASS. However, this was not statistically significant (OR 2.10, 95% CI 0.78 to 5.64; p=0.11; I2=42%; 11 studies; 4005 participants, random-effects analysis).8–11 42–44 47–49 There was no funnel plot asymmetry (intercept −0.29, 95% CI −2.78 to 2.21; p=0.805) using funnel plot inspection and Egger’s test (online supplemental eFigure 1).
Weight loss
Three studies reported weight loss as an outcome of the intervention.43 44 47 Mean weight loss was 0.74% of birth weight, and this result was statistically significant (MD 0.74; 95% CI −0.92 to 2.40; p=0.005; I2=87%; three studies; 289 participants) (online supplemental eFigure 2).
Cost
One study examined the effect of the interventions on cost per infant.11 ESC was found to be significantly associated with lower costs compared with the FNASS (SMD −2.79, 95% CI: −0.319 to −2.38; p<0.00001; one study; 186 participants; random-effects analysis, online supplemental eFigure 3).
Discussion
This systematic review and meta-analysis suggest that infants managed with ESC have better short-term outcomes, including shorter LOS and lower pharmacological treatment, compared with those treated with FNASS. Furthermore, there was no difference in the amount of NAS-related hospital admissions post-discharge with the ESC compared with the FNASS, although long-term information is scarce. These findings agree with other studies focused on rooming-in for infants with NAS, suggesting that using ESC may be associated with improved short-term outcomes.50 51 However, there is still not enough data to extrapolate if ESC is also beneficial in the long term.
LOS was shortened with the use of ESC compared with FNASS, but the mechanism for this is unclear. The institutions within the studies likely had better adherence to a standardised protocol, given ESC was implemented before data collection in most studies. One study demonstrated that adhering to standardised weaning processes reduced infant LOS by 8 days, regardless of treatment regimen or type of opioid used.52 ESC also resulted in a lower proportion of medicated infants, which may have contributed to reduced LOS.
While a reduced LOS is beneficial for reducing hospital costs and resource utilisation, this must be balanced with the overall safety of a shorter LOS or the prevalence of adverse effects and harms. Diop et al found that a shorter LOS between 0 and 6 days was associated with a twofold increase in readmission within 2–42 days of discharge, compared with infants with an LOS of 14–20 days.53 While 11 studies within this meta-analysis reported zero or very low rehospitalisation events, the intervention groups were small, at single sites and only measured up to 30 days postdischarge. These findings show divergence from an existing study, which demonstrated odds of 30-day and 1-year rehospitalisation to be 1.6 times higher for infants diagnosed with NAS compared with infants without NAS.54 Furthermore, another study found infants with NAS are twice as likely to die compared with children without NAS.55 Considering the concerning short-term and long-term risks that NAS presents, it is equally important to evaluate the long-term safety of ESC as well as the short-term impacts.
Infants treated with ESC were also exposed to less pharmacological therapy compared with those treated with FNASS. This may have been due to morphine being given on an as-needed basis as opposed to a regular schedule, thereby allowing staff and family to monitor fluctuations in withdrawal symptoms throughout the day and titrate appropriately.6 It has also been posited that maximising non-pharmacological management decreases the need for medication, but this is uncertain. There are benefits to non-pharmacological care, including increased family engagement and promoting the self-regulatory ability of the infant.56 However, there is minimal evidence to suggest that non-pharmacological measures significantly contribute to LOS or pharmacological treatment. A Cochrane review found that minimal conclusions could be drawn as to the effectiveness of non-pharmacological measures in NAS treatment, despite it being the first line in most treatment protocols.57
Other outcomes examined in this study included weight loss and cost. While a 0.74% difference in weight loss may not be clinically significant, it is worth noting that this result suggests that ESC does not lead to worse weight gain than other methods of NAS assessment. However, further studies comparing weight gain between ESC models of care and non-drug-exposed infants should be considered. The cost was only measured by one single-centre American study and, subsequently, while statistically significant, was not able to be extrapolated to other studies or countries.
The strengths of this study include that it is one of the first studies to systematically analyse QI studies of ESC implementation and subsequent infant outcomes and has demonstrated that ESC shows promise. The search strategy spanned multiple databases and was comprehensive given the minimal amount of studies. The small number of studies was likely due to the intervention being quite recent and could not be studied extensively throughout COVID-19.
A limitation of this study was the funnel plot asymmetry and positive intercepts noted in the LOS outcomes, suggesting evidence for publication bias. However, there are a variety of other reasons that could contribute to these results, including small-study effects, high heterogeneity and methodological differences between the studies. Subsequently, these results must be interpreted in the context of smaller-scale and likely biased studies. Subgroup and sensitivity analyses could also not be calculated due to data limitations. Future studies will need to expand on this limitation by providing more data for subgroup analyses, which could include separating gestational ages <35 weeks and >35 weeks or maternal buprenorphine versus methadone usage.
Our study has demonstrated that while ESC has perceived improved short-term outcomes and low adverse event rates, there are some important considerations that there is little information on. Namely, the absence of long-term safety or follow-up for infants managed with ESC and the lack of RCTs and standardised studies. As NAS rates increase worldwide, there needs to be a solution that will improve infant and family outcomes while reducing costs to the healthcare system. Before ESC becomes that solution, there needs to be thorough validation of this new tool and a better understanding of its outcomes.
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
Ethics statements
Patient consent for publication
Not applicable.
Contributors ZW carried out the statistical analyses, contributed to the data interpretation and drafted the initial manuscript. MEA-L contributed to the study design, statistical analyses, and data interpretation and critically reviewed the manuscript. JC assisted in the literature search, screening and data extraction for the articles. All authors critically reviewed and approved the final manuscript as submitted. J-LO conceptualised and designed the study, contributed to the data interpretation and led the writing. J-LO is the guarantor. All authors critically reviewed and approved the final manuscript as submitted. All authors had full access to all the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. We thank Jennifer Whitfield from UNSW Library for her input and advice in creating the search strategy.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
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