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Rapid Communication| Volume 7, ISSUE 1, P19-23, February 2021

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Infant sleep during COVID-19: Longitudinal analysis of infants of US mothers in home confinement versus working as usual

Published:November 23, 2020DOI:https://doi.org/10.1016/j.sleh.2020.11.004

      Abstract

      Objectives

      This study longitudinally compared the sleep of infants in the United States whose mothers were in home confinement to those whose mothers were working as usual throughout the COVID-19 pandemic.

      Methods

      Mothers of 572 infants (46% girls) aged 1-12 months (M = 5.9, standard deviation = 2.9) participated. Assessments were conducted on 4 occasions from late March to May 2020. Infant sleep was measured objectively using auto-videosomnography. Mothers reported their sheltering status, demographic characteristics, and infant sleep.

      Results

      Infants of mothers in home confinement had later sleep offset times and longer nighttime sleep durations, compared to infants of mothers who were working as usual. At the end of March, these infants also had earlier bedtimes, more nighttime awakenings, and more parental nighttime visits, but differences were not apparent during April and May.

      Conclusions

      Living restrictions issued in the United States may have led to longer sleep durations and temporary delays in sleep consolidation for infants of mothers in home confinement.

      Keywords

      Introduction

      The COVID-19 outbreak is having a massive impact on human lives. By the end of March 2020, most people in the United States were asked to “shelter in place,” with exceptions limited mostly to essential workers continuing their work outside of the house.

      Mervosh S, Lu D, Swales V. (20.4.2020) See which states and cities have told residents to stay at home. Retrieved from: https://www.nytimes.com/interactive/2020/us/coronavirus-stay-at-home-order.html. Accessed June 15, 2020.

      These dramatic restrictions have had a widespread impact on daily routines, health, and well-being.
      • Brooks SK
      • Webster RK
      • Smith LE
      • et al.
      The psychological impact of quarantine and how to reduce it: rapid review of the evidence.
      Specifically, the perils of home-confinement in relation to sleep have been repeatedly flagged by sleep experts,
      • Altena E
      • Baglioni C
      • Espie CA
      • et al.
      Dealing with sleep problems during home confinement due to the COVID‐19 outbreak: practical recommendations from a task force of the European CBT‐I Academy.
      ,
      • Becker SP
      • Gregory AM
      Editorial perspective: perils and promise for child and adolescent sleep and associated psychopathology during the COVID‐19 pandemic.
      and evidence of increased sleep difficulties in adults have already been documented.
      • Cellini N
      • Canale N
      • Mioni G
      • Costa S
      Changes in sleep pattern, sense of time and digital media use during COVID‐19 lockdown in Italy.
      • Lin L-y
      • Wang J
      • Ou-yang X-y
      • et al.
      The immediate impact of the 2019 novel coronavirus (COVID-19) outbreak on subjective sleep status.
      • Blume C
      • Schmidt MH
      • Cajochen C
      Effects of the COVID-19 lockdown on human sleep and rest-activity rhythms.
      However, no data have yet indicated how COVID-19 home-confinement has affected infant sleep.
      Sleep-wake patterns undergo dramatic evolution during the beginning of life. The multiple sleep episodes distributed across the 24-hour day in most newborn infants, gradually consolidate into one major nocturnal sleep episode towards the end of the first year.
      • Iglowstein I
      • Jenni OG
      • Molinari L
      • Largo RH
      Sleep duration from infancy to adolescence: reference values and generational trends.
      While these developments are inspired by physiological maturation of sleep homeostatic and circadian processes,
      • Jenni OG
      • Deboer T
      • Achermann P
      Development of the 24-h rest-activity pattern in human infants.
      ,
      • Jenni OG
      • Borbély AA
      • Achermann P
      Development of the nocturnal sleep electroencephalogram in human infants.
      they are also largely facilitated by environmental cues presented by the infant's parents.
      • Sadeh A
      • Tikotzky L
      • Scher A
      Parenting and infant sleep.
      Parents determine sleep timing and setting, and provide external regulation to facilitate the transition from wakefulness to sleep. Correspondingly, there is abundant evidence linking parents’ emotions, cognitions, and daily routines with their infants’ sleep patterns.
      • Camerota M
      • Propper CB
      • Teti DM
      Intrinsic and extrinsic factors predicting infant sleep: moving beyond main effects.
      Disruption in family routines may compromise infant sleep consolidation, as demonstrated by a recent study, linking household chaos with delays in infant sleep consolidation processes.
      • Whitesell CJ
      • Crosby B
      • Anders TF
      • Teti DM
      Household chaos and family sleep during infants’ first year.
      Parental stress and lower emotional availability at bedtime have also been linked with compromised infant sleep.
      • Sadeh A
      • Tikotzky L
      • Scher A
      Parenting and infant sleep.
      ,
      • Philbrook LE
      • Teti DM.
      Bidirectional associations between bedtime parenting and infant sleep: parenting quality, parenting practices, and their interaction.
      The major disruption to daily routines and stressful circumstances that COVID-19 stay-at-home orders have introduced in households across the United States may have similarly impacted infant sleep in the midst of this pandemic.
      Using objective sleep data, this study aimed to longitudinally compare the sleep of infants in the United States whose mothers were in home confinement to those whose mothers were essential workers, working as usual (EWAU), from late March (when “shelter in place” restrictions were issued), and through the beginning of May 2020. We hypothesized that infants of mothers in home confinement would show more fragmented sleep compared to infants whose mothers were EWAU. Considering the rapid evolution in sleep as infants grow in age, and their high dependency on mothers for sleep regulation early in life,
      • Sadeh A
      • Tikotzky L
      • Scher A
      Parenting and infant sleep.
      we expected that greater disruption in sleep associated with home confinement would be found in younger compared to older infants.

      Methods

      Participants

      Mothers of 572 infants (46% girls) aged 1-12 months (Mean = 5.9, Median = 6.0, standard deviation = 2.9) participated in this study. Participants resided across the United States (for a map depicting the distribution of participants across states, see supplementary Fig. S1). Table 1 presents baseline demographic characteristics for the entire sample, and separately for infants of mothers in home confinement and EWAU.
      Table 1Baseline demographic characteristics of infants and mothers presented for the entire sample, and separately for mothers in home confinement and essential, working as usual
      Entire sample (N = 572)Home confinement (N = 490)Essential, working as usual

      (N = 82)
      t/χ2
      Infants
      Age (months)5.9 (2.9)5.8 (2.9)6.8 (2.4)−3.04
      P < .05.
      Gender (% girls)263 (46%)221 (45%)42 (51%)0.99
      Number of children in family1.2 (0.5)1.2 (0.4)1.3 (0.7)−2.07
      Room sharing with parents129 (22.6%)108 (22.1%)21 (25.6%)0.50
      Breastfeeding264 (46.5%)226 (46.6%)38 (46.3%)0.01
      Mothers
      Age (years)6.72
       21-2415 (2.7%)12 (2.5%)3 (3.6%)
       25-29130 (22.8%)109 (22.3%)21 (25.6%)
       30-34274 (48.1%)235 (48.2%)39 (47.6%)
       35-39133 (23.3%)116 (23.8%)17 (20.7%)
       40-4418 (3.2%)16 (3.3%)2 (2.4%)
      Marital status0.40
       Domestic partnership or married547 (96.0%)469 (96.1%)78 (95.1%)
       Never married19 (3.3%)16 (3.3%)3 (3.7%)
       Separated, divorced or widowed4 (0.7%)3 (0.6%)1 (1.2%)
      Ethnicity4.86
       White/Caucasian462 (80.8%)402 (82.0%)60 (73.2%)
       Asian31 (5.4%)24 (4.9%)7 (8.5%)
       Hispanic56 (9.8%)44 (9.0%)12 (14.6%)
       African American10 (1.7%)9 (1.8%)1 (1.2%)
       Other13 (2.3%)11 (2.2%)2 (2.4%)
      Education2.06
       High school degree or less10 (1.7%)7 (1.4%)3 (3.7%)
       Some college62 (10.8%)53 (10.8%)9 (11.0%)
       College degree282 (49.3%)242 (49.4%)40 (48.8%)
       Postgraduate degree218 (38.1%)188 (38.4%)30 (36.6%)
      Household income13.76
      P < .05.
       <$50,00032 (5.6%)27 (5.5%)5 (6.1%)
       $50,000-$100,000129 (22.6%)106 (21.6%)23 (28.1%)
       $100,000-$150,000133 (23.3%)109 (22.2%)24 (29.3%)
       $150,000-$200,000108 (18.9%)96 (19.6%)12 (14.6%)
       >$200,000170 (29.7%)152 (31.0%)18 (22.0%)
      Employment status57.78
      P < .001.
       Full-time324 (56.9%)258 (53.0%)66 (80.5%)
       Part-time42 (7.4%)27 (5.5%)15 (18.3%)
       At home parent78 (13.7%)78 (16.0%)0 (0.0%)
       On maternity leave86 (15.1%)86 (17.7%)0 (0.0%)
       Unemployed/furloughed24 (4.3%)24 (4.9%)0 (0.0%)
       Student7 (1.2%)6 (1.2%)1 (1.2%)
       Other8 (1.4%)8 (1.6%)0 (0.0%)
      Data are given as mean (standard deviation) unless otherwise indicated.
      low asterisk P < .05.
      low asterisklow asterisk P < .001.

      Procedure

      Users of the Nanit baby monitor (described below) were invited via email to participate in a series of 4 online surveys about infant sleep throughout the COVID-19 pandemic. Survey links were sent once every 2 weeks between March 26 and May 7, 2020, and left active for 4 days. At each assessment, objective sleep data were collected using a computer-vision algorithm from the consecutive 10-day period prior to survey completion. Data were collected anonymously, and informed consent was obtained electronically prior to the first survey. IntegReview institutional review board approved the study (Nanit 2017-01; integreview.com). Participants who completed all 4 surveys were offered a respondent reward (raffle prize for 1 of 5 $100 gift cards).

      Measures

      Auto-videosomnography data. Infant sleep was assessed objectively using Nanit camera monitors in the naturalistic home-setting. These devices continuously record motion within the crib throughout a predefined nocturnal period. A computer-vision algorithm then translates motion-stillness patterns into sleep-wake patterns. Derived metrics have been previously validated against actigraphy as well as polysomnography.
      • Barnett N
      • Glazer A
      • Ivry T
      • Ankri Y
      • Veler H
      Computer vision algorithms outperform actigraphy (Conference abstract).
      The following metrics were used for this study: (1) number of nighttime awakenings; (2) number of parental nighttime crib visits; (3) sleep duration (total minutes scored as sleep within the sleep period); (4) sleep onset time, defined as the first minute of 5 consecutive minutes of sleep; and (5) sleep offset time, defined as the first minute of wakefulness after the last sleep segment before the infant is taken out of the crib.
      Parent reported data. At baseline, mothers completed a demographic online questionnaire, which included items regarding themselves and their infants (e.g., age, ethnicity). Additionally, at each of the 4 online surveys, they reported their employment status, and whether their infant breastfed or shared their bedroom in the past week. They also reported the average duration of infant daytime sleep. To assess sheltering status throughout the study, mothers were asked to indicate at each of the 4 time points whether they were in quarantine, following guidelines to “shelter in place,” essential workers working as usual, or unrestricted due to the coronavirus. Given that the study began a few days after restrictions were imposed in the United States, only N = 2 (0.2%) of mothers endorsed the latter option, and were removed from analyses. A binary measure was created, combining “quarantine” and “sheltering” categories, as compared to “essential, working as usual.”

      Data analysis plan

      Of the 727 US mothers who completed the baseline survey (including items regarding sheltering status and infant age), objective sleep data for at least 1 assessment was available for 572 infants aged 1-12 months, who comprised the final sample. Data were excluded if sleep onset times were detected outside the 5 PM-12 AM range (N = 9-13, 1.7%-2.5%), and/or sleep offset times were detected outside the 4 AM-9:30 AM range (N = 3-8, 0.5%-1.4%). Specifically, objective data were available for N = 515, N = 534, N = 541, and N = 549 infants at assessments 1-4, respectively. Parent reported data were available for N = 572, N = 334, N = 297, and N = 275 at assessments 1-4, respectively. Attrition was not associated with sheltering status. Outliers were identified using the interquartile range rule,
      • Hoaglin DC
      • Iglewicz B.
      Fine-tuning some resistant rules for outlier labeling.
      and winsorized by replacing the outlier with the closest value not identified as an outlier. No values were winsorized for sleep duration, 4-7 (0.7%-1.4%) values were winsorized for parental visits, and 2-3 (0.4%-0.5%) were winsorized for nighttime awakenings at different assessment points.
      Generalized estimating equations (GEE)
      • Ballinger GA.
      Using generalized estimating equations for longitudinal data analysis.
      longitudinal models with an autoregressive correlation structure were fitted for sleep outcomes, including main effects for time (4 assessments) and sheltering status (home confinement vs. EWAU), as well as their interaction terms. To test age moderation effects, models were additionally computed including infant time-by-sheltering status-by-age interaction terms. Significant interaction effects were interpreted using post hoc marginal means pairwise comparisons, for infants younger and older than the median. GEE accounts for repeated within-subject measurements, and accommodates missing data using the full information maximum likelihood approach. Based on significance in univariate analyses, adjusted models were fitted using infant age, mother's ethnicity, marital status, and household income as time-unvarying co-variates, as well as breastfeeding, room-sharing, and employment status as time-varying covariates.

      Results

      GEE modeling indicated that as time progressed, infants had longer objective nighttime sleep durations (Wald = 18.01, P < .001), fewer nighttime awakenings (Wald = 101.15, P < .001), fewer nighttime parental visits (Wald = 57.24, P < .001), earlier sleep offset times (Wald = 26.20, P< .001) and shorter reported daytime sleep durations (Wald = 64.75, P < .001). These correspond with normal developmental infant sleep trajectories.
      • Iglowstein I
      • Jenni OG
      • Molinari L
      • Largo RH
      Sleep duration from infancy to adolescence: reference values and generational trends.
      Across assessments, infants of mothers in home confinement had later objective sleep offset times (Mdifference = 9.2 minutes, SE = 4.5, Wald = 4.21, P = .04), and longer nighttime sleep durations (Mdifference = 13.9 minutes, SE = 6.5, Wald = 4.59, P = .03), compared with infants of EWAU mothers. Furthermore, significant time-by-sheltering status interaction effects emerged for the number of nighttime awakenings (Wald = 8.65, P = .03), parental nighttime visits (Wald = 13.82, P = .003) and sleep onset time (Wald = 11.07, P = .01; Fig. 1). These indexed that infants of mothers in home confinement had more nighttime awakenings (Mdifference = 0.5, P = .01), more crib visits (Mdifference = 0.6, P = .002) and earlier bedtimes (Mdifference = 20.2 minutes, P = .003) at the end of March, whereas differences were not apparent in later assessments. Furthermore, infant time-by-sheltering status-by-age interaction effects were found significant for parental nighttime visits (Wald = 9.71, P = .02) and reported daytime sleep duration (Wald = 9.95, P = .02). As shown in Fig. 2A, late-March differences between groups in nighttime crib visits were more pronounced in younger compared to older infants. Similarly, younger infants whose mothers were sheltering in place slept for longer durations throughout the day in March and April, whereas differences between groups were not apparent in older infants (Fig. 2B). Other main and interaction effects were nonsignificant.
      Fig 1
      Fig. 1Objectively measured number of infant nighttime awakenings (A), number of parental nighttime crib visits (B) and infant sleep onset time (decimal) (C) at each of the four assessment points, by sheltering status. P values and mean differences between infants of mothers in home confinement and infants of EWAU mothers are presented for each significant pairwise comparison. Error bars represent standard errors of the mean.
      Fig 2
      Fig. 2Objectively measured number of parental nighttime crib visits (A) and parent-reported daytime sleep durations (B) at each of the 4 assessment points, by sheltering status and infant age (younger infants were 1-6 months old, older infants were 7-12 months old). P values and mean differences between infants of mothers in home confinement and infants of EWAU mothers are presented for each significant pairwise comparison. Error bars represent standard errors or the mean.

      Discussion

      Using objective measurement of sleep and a longitudinal design, this study found that infants of mothers in home confinement woke up 9 minutes later, and slept for 14 minutes longer per night on average, compared to infants of EWAU mothers. Furthermore, at the end of March, these infants also had earlier bedtimes, more nighttime awakenings, and more parental nighttime visits. Interestingly, differences were no longer apparent during April and early May. Age significantly moderated these effects for nighttime visits, with more pronounced differences between groups in younger compared to older infants. In late March, 1–6-month-old infants of mothers in home confinement had approximately 1 more nightly crib visit compared to infants of EWAU mothers, whereas the equivalent difference was smaller (+0.6) in >6-month-old infants. Similarly, daytime sleep duration was significantly longer in infants of mothers in home confinement compared to infants of EWAU mothers in the first 3 assessments, but this was true only for younger infants.
      Taken together, our findings index longer, yet less consolidated sleep in infants of mothers in home confinement following COVID-19 restrictions. Such fragmented sleep-wake patterns are characteristic of young infants, whose sleep is usually distributed across the day and night.
      • Sadeh A
      • Mindell JA
      • Luedtke K
      • Wiegand B
      Sleep and sleep ecology in the first 3 years: a web‐based study.
      The longer sleep periods, indicated by earlier bedtimes and later rise times along with prolonged daytime sleep durations in younger infants, seem to have been “traded-off” with more nocturnal awakenings and visits, possibly by reducing sleep homeostatic pressure.
      • Jenni OG
      • LeBourgeois MK.
      Understanding sleep–wake behavior and sleep disorders in children: the value of a model.
      Differences between groups may have originated from changes in daytime routines associated with home-confinement, as EWAU mothers may have maintained more regular schedules, which have been shown to promote infant sleep.
      • Sadeh A
      • Tikotzky L
      • Scher A
      Parenting and infant sleep.
      Moreover, spending more time at work and away from the child may have contributed to later bedtimes in infants of EWAU mothers,
      • Magee CA
      • Caputi P
      • Iverson DC
      Are parents’ working patterns associated with their child's sleep? An analysis of dualparent families in Australia.
      thus consolidating infant sleep via increased homeostatic pressure. Differences may have also been driven by parental emotional or stress-related factors, associated with being in lockdown.
      • Brooks SK
      • Webster RK
      • Smith LE
      • et al.
      The psychological impact of quarantine and how to reduce it: rapid review of the evidence.
      Such factors have previously been linked with increased parental involvement with the infant's sleep, more infant sleep disruptions (e.g., more frequent awakenings), and less success in improving infant sleep via intervention.
      • Sadeh A
      • Tikotzky L
      • Scher A
      Parenting and infant sleep.
      ,
      • Philbrook LE
      • Teti DM.
      Bidirectional associations between bedtime parenting and infant sleep: parenting quality, parenting practices, and their interaction.
      ,
      • Sadeh A
      • Juda‐Hanael M
      • Livne‐Karp E
      • et al.
      Low parental tolerance for infant crying: an underlying factor in infant sleep problems?.
      ,
      • Kahn M
      • Livne-Karp E
      • Juda-Hanael M
      • et al.
      Behavioral interventions for infant sleep problems: the role of parental cry tolerance and sleep-related cognitions.
      Of note, most differences in sleep metrics were only apparent at the end of March, closely after restrictions were imposed in the United States. The lack of differences between groups in later assessments may be reflective of improved adjustment to the novel situation of home-confinement after a few weeks of experiencing it. This is in line with a recent longitudinal study reporting reductions in psychological impact at 4 weeks, compared to directly following the COVID-19 outbreak in China.
      • Wang C
      • Pan R
      • Wan X
      • et al.
      A longitudinal study on the mental health of general population during the COVID-19 epidemic in China.
      In addition, despite the dramatic circumstances generated by the pandemic, sleep of infants in this study consolidated across time. These findings may demonstrate the plasticity of good sleep of infants when exposed to a novel situation—a finding previously found in adults.
      • Richardson C
      • Gradisar M
      • Pulford A
      The development of insomnia or the plasticity of good sleep? A preliminary study of acute changes in sleep and insomnia resulting from an analogue trauma.
      ,
      • Espie CA
      Insomnia: conceptual issues in the development, persistence, and treatment of sleep disorder in adults.
      Interestingly, younger infants were more largely impacted by maternal sheltering status compared to older infants. Infants aged 1-6 months of mothers sheltering in place slept for 41 minutes longer during the daytime in late March, and had 1 additional nighttime visit on average, compared to infants of EWAU mothers. These pronounced effects may be due to a greater dependency on mothers early on in a child's life,
      • Sadeh A
      • Tikotzky L
      • Scher A
      Parenting and infant sleep.
      as well as by a relative lack of structure for younger infants. Structured schedules may have already been established for older infants, making their daytime sleep-wake routines more durable in the face of changes in maternal routines.
      • Bathory E
      • Tomopoulos S
      Sleep regulation, physiology and development, sleep duration and patterns, and sleep hygiene in infants, toddlers, and preschool-age children.
      Given the importance of sufficient good quality sleep for the well-being of both infants and their parents, our findings hold substantial clinical importance. Longer sleep duration has been associated with a myriad of beneficial outcomes in young children, including improved health, cognitive functioning, and emotion and behavior regulation.

      Chaput J-P, Gray CE, Poitras VJ, et al. Systematic review of the relationships between sleep duration and health indicators in the early years (0–4 years). 2017;17(5):855.

      For example, sleep extension of 27 minutes per night on average resulted in reduced emotional lability and impulsivity in school aged children.
      • Gruber R
      • Cassoff J
      • Frenette S
      • Wiebe S
      • Carrier J
      Impact of sleep extension and restriction on children's emotional lability and impulsivity.
      While research delineating precise dose-response effects in infants are lacking, the impact of additional sleep may be even stronger in this population, due to the vast developmental processes occurring during sleep in infancy.
      • Fifer WP
      • Byrd DL
      • Kaku M
      • et al.
      Newborn infants learn during sleep.
      Thus, the additional 14 minutes of sleep per night found in infants of mothers sheltering in place, as well as the additional 41 minutes of daytime sleep found in younger infants of home confined mothers, may have had substantial advantageous implications. On the other hand, our findings revealed more fragmented sleep in infants of mothers sheltering in place following COVID-19 restrictions, as well as more parental crib visits. Sleep fragmentation has been linked with adverse outcomes for both infants and parents.
      • Kahn M
      • Fridenson S
      • Lerer R
      • Bar-Haim Y
      • Sadeh A
      Effects of one night of induced night-wakings versus sleep restriction on sustained attention and mood: a pilot study.
      ,
      • Mäkelä TE
      • Peltola MJ
      • Saarenpää‐Heikkilä O
      • et al.
      Night awakening and its association with executive functioning across the first two years of life.
      Considering the “trade-off” between longer and more fragmented sleep that extended sleep opportunities may present, balancing sleep quantity and quality may pose a challenge for parents in the face of changing circumstances, such as those presented by COVID-19 restrictions.
      Several limitations merit consideration. First, we were not aware of the type of work mothers were performing. Given recent evidence of increased sleep problems in healthcare workers throughout COVID-19,
      • Pappa S
      • Ntella V
      • Giannakas T
      • Giannakoulis VG
      • Papoutsi E
      • Katsaounou P
      Prevalence of depression, anxiety, and insomnia among healthcare workers during the COVID-19 pandemic: a systematic review and meta-analysis.
      differentiating between mothers working in the healthcare system (e.g., doctors/nurses), and essential workers from other fields (e.g., postal/grocery store workers) could have yielded a more detailed representation of infant sleep as a function of their mothers’ sheltering/working status. Second, data were not collected regarding the sheltering status of mothers’ domestic partners or regarding the type of infant care while mothers were at work, limiting our understanding of broader environmental influences on infant sleep. For example, differences may have been found between infants whose parents were both confined to the home, compared to those with one or both parents working outside the house. Furthermore, associations between maternal and infant sleep could have shed light on the mechanistic processes underlying the effects of home confinement on sleep of infants and their mothers, and future studies may wish to investigate these links. Finally, the relatively homogeneous sample, representative mostly of middle-upper socioeconomic status in the United States that have access to these camera monitors, limits the generalizability of our findings. Further work is warranted to examine the impact of home confinement during the COVID-19 pandemic on infant sleep in more diverse populations.
      Notwithstanding these limitations, to the best of our knowledge, this study is the first to present longitudinal objective findings regarding infant sleep patterns during the COVID-19 pandemic. Findings suggest that living restrictions issued toward the end of March in the United States may have led to longer sleep durations, as well as temporary regressions or delays in sleep consolidation for infants of mothers in home confinement, which subsided as time progressed. As these unprecedented circumstances unfold—or additional “waves” occur—more work is required to understand the influences of lockdown measures on infant sleep, and their underlying mechanisms.

      Declaration of conflict of interest

      (a) Financial disclosure: MK and NB have served as consultants for Nanit. AG was an employee of Nanit at the time of study implementation. MG has served a Pro-Bono consultant for Nanit.
      (b) Nonfinancial disclosure: None.

      Funding

      This study was supported by Nanit.

      Acknowledgments

      The authors wish to thank the participating families for their contribution to the study.

      Appendix. Supplementary materials

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