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    Oxygen Saturation Nomogram in Newborns Screenedfor Critical Congenital Heart Disease

    WHATS KNOWN ON THIS SUBJECT: Universal oxygen saturationscreening by pulse oximetry is now recommended for early

    detection of critical congenital heart disease. The distribution of

    saturations in asymptomatic newborns in a large population has

    not been described.

    WHAT THIS STUDY ADDS: Our study is the largest to date to

    establish simultaneous pre- and postductal oxygen saturation

    nomograms in asymptomatic newborns at 24 hours after birth.

    The mean postductal saturation is higher than preductal during

    this time.

    abstractOBJECTIVE: To establish simultaneous pre- and postductal oxygen

    saturation nomograms in asymptomatic newborns when screening

    for critical congenital heart disease (CCHD) at 24 hours after birth.

    METHODS:Asymptomatic term and late preterm newborns admitted to

    the newborn nursery were screened with simultaneous pre- and post-

    ductal oxygen saturation measurements at 24 hours after birth. The

    screening program was implemented in a stepwise fashion in 3

    different afliated institutions. Data were collected prospectively from

    July 2009 to March 2012 in all 3 centers.

    RESULTS:We screened 13 714 healthy newborns at a median age of 25

    hours. The mean preductal saturation was 98.29% (95% condence

    interval [CI]: 98.2798.31), median 98%, and mean postductal satura-

    tion was 98.57% (95% CI: 98.5598.60), median 99%. The mean differ-

    ence between the pre- and postductal saturation was 20.29% (95%

    CI: 20.31 to 20.27) with P, .00005. Its clinical relevance to CCHD

    screening remains to be determined. The postductal saturation was

    equal to preductal saturation in 38% and greater than preductal

    saturation in 40% of the screens.

    CONCLUSIONS:We have established simultaneous pre- and postductaloxygen saturation nomograms at 24 hours after birth based on

    .13 000 asymptomatic newborns. Such nomograms are important to

    optimize screening thresholds and methodology for detecting CCHD.

    Pediatrics 2013;131:e1803e1810

    AUTHORS:Priya Jegatheesan, MD,

    a

    Dongli Song, MD, PhD,

    a

    Cathy Angell, MD,a,b Kamakshi Devarajan, MD,c and Balaji

    Govindaswami, MBBS, MPHa

    aDepartment of Pediatrics-Neonatology, Santa Clara Valley

    Medical Center, San Jose, California; bDepartment of Pediatrics-

    Neonatology, OConnor Hospital, San Jose, California; andcDepartment of Pediatrics-Neonatology, St. Francis Medical

    Center, Lynwood, California

    KEY WORDS

    critical congenital heart disease, universal screening, pulse

    oximetry screening, oxygen saturation screening, oxygen

    saturation nomogram, pre- and postductal saturations,

    asymptomatic newborns

    ABBREVIATIONS

    CCHDcritical congenital heart disease

    CIcondence interval

    Dr Jegatheesan designed the study, designed the data collection

    instruments, supervised data collection, performed the data

    analysis, drafted the initial article, revised and approved the

    nal article as submitted; Dr Song designed the study, reviewed

    the analysis, critically reviewed the article, and approved the

    nal article as submitted; Drs Angell and Devarajan coordinated

    and supervised data collection at 1 of the 3 sites, critically

    reviewed the article, and approved the nal article as

    submitted; and Dr Govindaswami conceptualized and designed

    the study, critically reviewed the article, and approved the nal

    article as submitted.

    www.pediatrics.org/cgi/doi/10.1542/peds.2012-3320

    doi:10.1542/peds.2012-3320

    Accepted for publication Feb 8, 2013

    Address correspondence to Priya Jegatheesan, MD, Division of

    Neonatology, Department of Pediatrics, Santa Clara Valley

    Medical Center, 751 South Bascom Ave, San Jose, CA 95128.

    E-mail: [email protected]

    PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

    Copyright 2013 by the American Academy of Pediatrics

    FINANCIAL DISCLOSURE: The authors have indicated they have

    nonancial relationships relevant to this article to disclose.

    FUNDING: Supported by Santa Clara County First Five Program.

    PEDIATRICS Volume 131, Number 6, June 2013 e1803

    ARTICLE

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    Critical congenital heart disease (CCHD)

    is dened as congenital heart disease

    that requires surgical intervention

    during infancy for survival. This occurs

    in 1 to 2/1000 live births, and fewer than

    50% of these conditions1 are diagnosed

    prenatally. Some newborns with CCHDremain asymptomatic in the rst few

    days after birth. Physical examination

    fails to identify 30% to 50% of CCHD

    before discharge.2 Delay in identica-

    tion of CCHD leads to severe morbidity

    or mortality as many of these un-

    diagnosed newborns become critically

    ill with cardiovascular collapse. Pulse

    oximetry screening can be used to

    identify CCHD in asymptomatic new-

    borns to lessen the burden of un-diagnosed CCHD.35 Multiple studies

    have evaluated different screening

    methodologies including postductal ox-

    ygen saturation measurements alone,69

    or both pre- and postductal4,10 satu-

    rations. There are also considerable

    differences in both the timing of

    screening (from 4 to 2472 hours after

    birth)610 and the threshold values

    (from #92% to #96%). This has led to

    widely varying sensitivity from 50% to100% and false-positives from 0.01%

    to 5.6%. Increasing the sensitivity and

    reducing the false-positive rate requires

    optimizing the screening methodology.

    Accuracy and efcacyof CCHD screening

    programs depend on understanding

    oxygen saturation distribution in new-

    borns in the rst few days after birth.

    Oxygen saturation in newborns in the

    rst week after birth was described in

    an early physiology study11 whereinblood gas oxygen saturation was mea-

    sured by cooximetry. Subsequent

    studies have used noninvasive pulse

    oximetry to measure oxygen saturation.

    Our current knowledge of oxygen satu-

    ration in newborns comes from studies

    done immediately after birth1216 and in

    the rst 24 hours after birth.12,1720

    Some studies have assessed oxygen

    saturation from single sites alone and

    others from both pre- and postductal

    sites. The pre- and postductal satu-

    rations were obtained by sequential

    measurements15,18,19 in some studies

    and by simultaneous measurements in

    others.12,16 Rosvik et al20 described

    postductal saturation in the rst 6

    hours in .6800 newborns screened

    for CCHD, but there has been no similar

    study using both pre- and postductal

    oxygen saturation.

    We implemented a pulse oximetry

    screening program in our institution in

    August 2009, following the de-Wahl

    Granelli method, which included pre-

    and postductal saturation screening10

    and the Koppel method of screening

    after 24 hours.6 In addition, we mea-

    sured pre- and postductal saturations

    simultaneously instead of consecu-

    tively. Evaluating pre- and postductal

    oxygen saturation in large numbers of

    asymptomatic newborns is essential in

    dening threshold values for CCHD

    screening. The objective of this study

    was to describe the distribution of si-

    multaneous pre- and postductal oxygen

    saturation in asymptomatic newborns

    who undergo screening for CCHD at

    24 hours after birth.

    METHODS

    Program Sites

    We implemented the pulse oximetry

    screening program in a stepwise

    manner in 3 institutions. A pilot pro-

    gram was implemented in August 2009

    at our primary site, center 1 (Santa

    Clara Valley Medical Center, San Jose,CA, a public hospital with 5000 de-

    liveries annually with a regional level 3

    NICU). We subsequently expanded to

    universal screening in January 2010.

    Universal screening was implemented

    in July 2011 at center 2 (OConnor

    Hospital, San Jose, CA, a nonprot

    hospital with 4000 deliveries annu-

    ally with a community level 3 NICU), andin January 2012 at center 3 (St. Francis

    Medical Center, Lynwood, CA, a non-

    prot hospital with 6000 deliveries

    annually with a community level 3

    NICU). All 3 centers are at sea level

    (,100 ft elevation).

    Subjects

    Asymptomatic newborns born at $34

    weeksgestation admitted to the new-

    born nursery were screened utilizingpulse oximetry for CCHD at 24 hours

    after birth.

    Screening Method

    Simultaneous pre- and postductal oxy-

    gen saturations of all asymptomatic

    newborns were recorded by nursing

    staff at 24 hours after birth. We used

    reusable probes with disposable wrap

    ($1.4$1.9/disposable wrap; Masimo

    Corporation, Irvine, CA). The probeswere placed on the right palm or wrist

    for preductal and on either foot for

    postductal saturation. The oxygen sat-

    uration values were recorded when

    both pre- and postductal pulse oxime-

    try had stable waveforms and their

    heart rates were correlating. The

    equipment and pulse oximetry tech-

    nology used in all 3 institutions were

    newer-generation, motion-tolerant devi-

    ces (Table 1) with 8 to 10 seconds aver-aging time. The pulse oximetry screen

    was considered pass if either the

    TABLE 1 Pulse Oximetry Screening Equipment

    Pulse Oximetry Equipment/Technology Probes

    Center 1 a

    Masimo Rad-87/SET Reusable

    Center 2 Masimo Rad-5/SET andb

    Philips/FAST Reusable

    Center 3 Masimo Rad-87/SET Reusable

    FAST, Fourier artifact suppression technology; SET, signal extraction technology.a Masimo (Masimo Corporation, Irvine, CA).b Philips (Philips Healthcare, Andover, MA).

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    pre- or postductal saturation was

    $95% and the difference between the

    2 was #3%. The screen was consid-

    ered a fail if either the pre- or post-

    ductal saturation was ,90%. A fail

    triggered a prompt clinical evaluation

    by a pediatric provider and transfer tothe NICU if indicated. The screen was

    repeated if either the pre- and post-

    ductal saturations were 90% to 94%, or

    there was a .3% difference. If the re-

    peat screen within 4 hours remained

    the same, then it was considered a fail.

    Failed screens were followed with an

    echocardiogram before discharge.

    Data Collection

    The oxygen saturation values of allscreens from August 2009 to March

    2012 were documented by nursing staff

    and entered into study data set by

    a research assistant. The number of

    repeat screens was also collected.

    Those screens that had either pre- or

    postductal values missing were re-

    moved from the data set. Additional

    variables collected in a subset of

    newborns included the following: ges-

    tational age, birth weight, gender, anddelivery type.

    Data Analysis

    The distribution of simultaneous pre-

    and postductal oxygen saturations and

    their differences is presented in a box

    plot and summarized as means with

    95% condence intervals (CIs) and

    medians with percentiles. The mean,

    median, and percentile values for the

    subgroups based on center, gender,gestational age (preterm versus term),

    and age of screening (,20 hours, 21

    28 hours, 2936 hours, 3748 hours,

    and .48 hours) were calculated. As

    the oxygen saturations were not nor-

    mally distributed but were skewed to

    the left, nonparametric tests were used

    for comparisons. Pre- and postductal

    saturations and their differences were

    compared between groups by using

    the Wilcoxon Mann-Whitney rank sum

    test and the Kruskal-Wallis test (for

    multiple groups). The paired pre- and

    postductal oxygen saturation differ-

    ences were compared by using the

    Wilcoxon signed rank test. Statistical

    data analysis software Stata 10.0(Stata Corp, College Station, TX) was

    used for the analysis.

    The number of screens that needed to

    be repeated per protocol, number of

    fails per protocol, and the number of

    protocol violations per center were

    collected and summarized. Protocol

    violations were dened as failure to

    repeat a screen in newborns who met

    criteria for rescreening and failure to

    perform an echocardiogram in thosewho failed the screen.

    RESULTS

    Oxygen Saturation Nomograms

    A total of 13 714 newborns were

    screened. The mean preductal satura-

    tion was 98.29% (95% CI: 98.2798.31),

    and the median was 98%. The meanpostductal saturation was 98.57% (95%

    CI: 98.5598.60), and the median was

    99% (Fig 1A). Of screened asymptomatic

    newborns, 99.5% had pre- or postductal

    saturations $95%. Figure 1B reveals

    the percentile distribution of the pre

    and postductal oxygen saturations.

    Pre- and Postductal Saturation

    Difference

    In our study, 99.5% of asymptomaticnewborns had a pre- and postductal

    FIGURE 1A, Simultaneous pre- and postductal oxygen saturation nomogram in asymptomatic newborns. Si-

    multaneous pre- and postductal oxygen saturation distribution in 13 714 asymptomatic newborns. The

    boxes represent the interquartile range from 25th to 75th percentile. The marker within the box is the

    median and the whiskersreach 1.5 times interquartile range. B, Percentile distribution of pre- and

    postductal oxygen saturations.

    ARTICLE

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    saturation difference of#3% (Fig 2).

    Pre- and postductal saturations were

    the same in 38%; preductal was

    greater in 22%, and postductal was

    greater in 40% of the screens. The

    mean difference between pre- and

    postductal saturation was 20.29%(95% CI: 20.31 to 20.27), which was

    statistically signicant (P , .00005),

    and the median was 0.

    Subgroups

    The mean, median, and the percentile

    valuesof thepre-and postductal oxygen

    saturation in the different subgroups is

    shown inTable 2. There was no differ-

    ence between the pre- and postductal

    saturation in boys versus girls. Pre-ductal values in the cesarean delivery

    group were higher than those de-

    livered vaginally, but their postductal

    saturations were not different. Post-

    ductal saturation in preterm newborns

    was lower than term newborns, but

    their preductal saturations were not

    different. Center 2 had a higher pre-

    ductal saturation compared with the

    others but not the postductal.

    The mean difference between the pre-and postductal saturation ranged from

    20.12 to20.33, which was statistically

    signicant in all subgroups. There was

    no signicant difference between boys

    and girls, term versus preterms, or

    cesarean delivery versus vaginal de-

    livery. However, center 2 had a lower

    difference of20.13 compared with 2

    0.3 in the other 2 centers.

    Age of ScreeningThe age of screening data were avail-

    able in 13 287 newborns. The median

    age of screening was 25 hours. Ninety-

    seven percent of screening was done

    between 21 and 36 hours. There was no

    signicant difference in preductal or

    between pre- and postductal satu-

    rations between the age categories

    (Table 3). Although postductal satura-

    tion between the groups was statistically

    different, it did not remain signicant

    when individual groups were com-pared. The pre- and postductal oxygen

    saturation differences ranged from20.21

    to20.49 for all ages and are statistically

    signicant.

    Screening Program

    In our study, on the rst screening, 13

    615 (99.3%) passed, 8 failed, and 91

    (0.66%) required a repeat (Fig 3). Of the

    91, only 55 screens were repeated; 5

    failed the repeat screen. There werea total of 42 (0.3%) protocol violations;

    35 due to failure to repeat a screen, 1

    due to obtaining an echo before repeat,

    and 6 due to failure to obtain an echo

    for oxygen saturation ,90%. The

    number of repeats, protocol violations,

    and failed screens by center is

    shown in Table 4. In total, 8 echo-

    cardiograms were done as a result of

    the CCHD screen, and 2 of those

    FIGURE 2Difference between pre- and postductal oxygen saturation in asymptomatic newborns. The difference

    between simultaneous pre- and postductal oxygen saturation distribution in 13 714 asymptomatic

    newborns. The box represents the interquartile range from 25th to 75th percentile. The marker within

    the box is the median and the whiskersreach the 1.5 times interquartile range.

    TABLE 2 Pre- and Postductal Oxygen Saturation Distribution in Subgroups

    N Pre Post Difference Within group

    Mean (Median,

    1st99th Percentile)

    Mean (Median,

    1st99th Percentile)

    Mean Pa

    All 13 714 98.29 (98, 95100) 98.57 (99, 95100) 20.29 ,.00005

    Boy 5689 98.25 (98, 95100) 98.58 (99, 95100) 20.33 ,.0001

    Girl 5562 98.26 (98, 95100) 98.56 (99, 95100) 20.3 ,.0001

    Between groupsPb

    .8 .5 .4

    Vagi nal delivery 654 98.45 (98, 95100) 98.78 (99, 96100) 20.33 ,.0001

    Cesarean delivery 247 98.73 (99, 96100) 98.91 (99, 96100) 20.18 .024

    Between groupsPb

    .002 .1 .06

    Term 2869 98.49 (99, 95

    100) 98.67 (99, 96

    100) 2

    0.18 ,

    .0001Preterm 122 98.25 (98, 94100) 98.38 (98, 94100) 20.12 .045

    Between groupsPb

    .1 .03 .96

    Center 1 10 290 98.26 (98, 95100) 98.58 (99, 95100) 20.32 ,.0001

    Center 2 2081 98.46 (98, 95100) 98.59 (99, 95100) 20.13 ,.0001

    Center 3 1343 98.24 (98, 94100) 98.50 (99, 94100) 20.27 ,.0001

    Between groupsPc

    .0001 .5 ,.0001

    , Data not applicable.a Pis from Wilcoxon signed rank test.b Pis from Mann-Whitney rank sum test.c Pis from Kruskal-Wallis multiple group comparisons.

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    newborns had CCHD (Tetralogy of Fallot

    and Ebstein anomaly).

    DISCUSSION

    Our study is the rst to establish si-

    multaneous pre- and postductal oxygensaturation nomograms, at sea level, at

    24 hours after birth, using a large

    sample of .13 000 asymptomatic

    newborns. We show that 99% of the

    newborns have both pre- and post-

    ductal saturations $95% and that the

    preductal oxygen saturation is often

    less than postductal at the time of

    screening. This nding has not been

    previously reported.

    Weshow thatthemean (6 SD) pre- and

    postductal oxygen saturations are

    98.3 6 1.4 and 98.6 6 1.3, respectively.These values appear to be slightly

    higher than those described in earlier

    studies.11,12,18,21 In 1968, Koch et al11

    used cooximetry from umbilical artery

    blood gases in 17 newborns and

    reported a mean (6 SD) postductal

    oxygen saturation of 96.8 61.7 at 24

    hours after birth. Dimich et al12

    reported mean (6 SD) pre- and post-

    ductal saturations of 95.7 6 2.2 and

    95.26 2.3 at 24 hours in 100 newborns

    by using Ohmeda pulse oximetry.

    Fractional oxygen saturation measuredthis way may be up to 2% lower than

    the pulse oximeters used in our study,

    as it approximates the average car-

    boxyhemoglobin and methemoglobin

    levels present in healthy nonsmoking

    adults.22 A recent study with newer

    generation pulse oximetry describes

    the mean pre- and postductal satura-

    tion at 24 hours as 97.26 1.6.18 Despite

    these discrepancies, all these studies

    are consistent in revealing that a ma-jority of newborns have oxygen satu-

    ration $95% at 24 hours after birth.

    The difference between pre- and post-

    ductal saturation has been described in

    the rst few days after birth. Studies

    done immediately after birth12,16 and

    within 4 hours after birth15,18 have

    revealed that the preductal is greater

    than the postductal saturation. Lev-

    esque et al18 described pre- and

    postductal saturations measured con-secutively by using Novametrix pulse

    oximetry on admission to the nursery,

    at 24 hours and at discharge in

    718 normal newborns. They reported

    that there was a tendency for the pre-

    ductal to be higher by 0.3% than post-

    ductal at 2.7 hours after birth, but this

    difference was not observed at 24

    hours. Dimich et al12 measured pre- and

    postductal saturations simultaneously

    at 24 hours in 100 newborns with a dif-ferent pulse oximetry device (Ohmeda

    Biox 3700) and showed that the mean

    preductal saturation was higher than

    postductal saturation (although it did

    not attain statistical signicance). Our

    observation that the mean preductal is

    lower than the postductal saturation

    has not been described previously. This

    difference is very small (20.29%) and

    within the inherent margin of error

    TABLE 3 Pre and Postductal Oxygen Saturation Based on Age of Screening

    Age of Screening, h n Preductal Postductal Difference Pa

    Mean (Median,

    1st99th Percentile)

    Mean (Median,

    1st99th Percentile)

    Mean

    #20 71 98.4 (99, 94100) 98.9 (99, 96100) 20.49 .001

    2128 h 10 840 98.3 (98, 95100) 98.6 (99, 95100) 20.3 ,.0001

    2936 h 1983 98.3 (98, 95100) 98.5 (99, 95100) 20.21 ,.0001

    3748 h 234 98.2 (98, 95100) 98.5 (99, 96100) 20.23 .0039

    .48 h 159 98.4 (99, 94100) 98.8 (99, 96100) 20.4 .0001

    Between groupsPb

    .6 .0015 .06

    , Data not applicable.a Pis from Wilcoxon signed rank test.b Pis from Kruskal-Wallis multiple group comparisons.

    FIGURE 3Screening program ow diagram.

    TABLE 4 Screening Program

    Total Screened Repeat Screens Protocol Violat ions Failed Screens

    Center 1 10 290 62 29 4

    Center 2 2081 11 8 3

    Center 3 1343 18 5 6

    Total 13 714 91 (0.7%) 42 (0.3%) 13 (0.1%)

    ARTICLE

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    associated with pulse oximetry devices.23

    Our study had a large sample size and

    hence could detect very small differ-

    ences. It is also possible that such

    small differences can only be noted by

    simultaneous measurements. It is un-

    clear whether this observation isphysiologic or due to methodological

    or technological bias. All 3 centers in

    our study revealed that the preductal

    saturation was lower than or equal

    to the postductal saturation in most

    cases. This observation is unlikely to be

    due to random chance because the

    same discrepancy was observed in all

    3 centers despite the use of different

    devices. Although this nding is of un-

    clear clinical signi

    cance, it may berelevant to the discussion of the opti-

    mal screening methodology to detect

    CCHD and requires further validation.

    Deliveryroom studieshave revealed that

    infants born via cesarean delivery have

    lower oxygen saturation immediately

    after birth and that it increases within

    few minutes after birth.13,16,24,25 In-

    terestingly, we found that both pre- and

    postductal saturations 24 hours after

    birth were slightly higher in those bornvia cesarean delivery compared with

    those delivered vaginally, although only

    the preductal saturation was statisti-

    cally signicant. Another recent large

    study also revealed higher postductal

    saturation between 2 and 24 hours in

    infants born by cesarean delivery.20

    Again, the reason for this observation is

    unclear. Multiple studies have revealed

    that preterm newborns have lower

    saturations at 5 minutes after birth.14,25

    We found that this persists even at 24

    hours. Even though these differences in

    cesarean delivery versus vaginal de-

    liveries and term versus preterm new-

    borns are statistically signicant, they

    are too small to indicate a different

    threshold for CCHD screening.

    Pulse oximetry hasbeen usedin multiple

    CCHD screening studies since the early

    2000s with different methods. The

    variability of published false-positive

    rates is most related to age at screen-

    ing. Mahle et al26 summarized that the

    false-positive rate was 0.035% when the

    screening was done after 24 hours

    compared with 0.9% for all studies in-

    cluding early screening at 4 to 6 hours.Our experience reveals that very few

    newborns (0.09%) fail the screen when

    done at 24 hours. There is still con-

    troversy regarding whether to do both

    pre- and postductal screens or only

    postductal for CCHD screening. There

    were 2 cases in the 39 821 screened by

    de Wahl Granelli et al,19 that were

    detected only by the difference between

    pre- and postductal difference. In our

    experience, the nursing time for thetotal screen was,5 minutes, which led

    to minimal increase in cost. We used the

    reusable probe to do our screening that

    led to an added cost of ,$1.5 per

    screen. We followed the de-Wahl Granelli

    method of screening both pre- and

    postductal saturations to increase the

    detection of CCHD cases and justied

    the minimal added cost.4,19 In our study,

    91 newborns required a repeat screen,

    75% of which were triggered by a .3%difference; 90% passed the repeat

    screen. The number of CCHD cases in

    our study is too small to make any ar-

    gument regarding single postductal

    versus pre- and postductal screens. In

    fact, the cumulative published satura-

    tion experience to date may still be in-

    sufcient to makeconclusions about the

    optimal methodology for CCHD screen-

    ing. Regardless of what methodology is

    used, ongoing oxygen saturation datacollection in large numbers is essential

    to better rene the thresholds for CCHD

    screening in the future. Furthermore,

    cost effectiveness analysis need to be

    performed to address whether the

    added cost of both pre and postductal

    screening justify the benet of increase

    in sensitivity to detect CCHD.

    Our study protocol is identical to the

    recent national recommendation put

    out by the work group for the Secre-

    tarys Advisory Committee on Heritable

    Disorders in Newborns and Children,

    which strategized implementation of

    screening for CCHD27; therefore, it is

    important to evaluate our protocol

    adherence. We had successful protocoladherence in 99.7% of the newborns

    from all 3 centers, demonstrating the

    feasibility of this protocol. There were

    42 (0.3%) protocol violations in our

    study: 35 due to failure to repeat

    a screen, 1 due to obtaining an echo

    before repeat screening, and 6 due to

    failure to obtain an echocardiogram

    for oxygen saturation ,90%. Eight

    newborns who failed the rst screen

    with saturation ,90% should haveundergone an echocardiogram per

    protocol, but 6 out of the 8 had a repeat

    screen and passed. This suggests

    a role for repeating the screen even

    when 1 saturation is ,90% in asymp-

    tomatic newborns. This would further

    decrease the number of unnecessary

    echocardiograms done due to failed

    screens. As universal screening be-

    comes more widespread, it is critical

    that protocol adherence be monitoredcarefully.

    One of the important limitations of our

    study is that we do not have the out-

    comes of all screened newborns, espe-

    cially those with protocol violations who

    did not get a repeat screen. We did have

    follow-up data from readmissions with

    CCHD, outpatient echocardiograms in

    the rst year, and deaths due to CCHD in

    the birthing county to identify missed

    cases. However, linkage of the birthhospital data to the Society of Thoracic

    Surgeons national database (STS) and

    interventional cardiology, Improving

    Pediatric And Adult Congenital Treat-

    ment (IMPACT) data sets and deaths due

    to undiagnosed CCHD is unavailable for

    accurate identication of all missed

    CCHD cases.28,29 We used only 2 types of

    pulse oximetry devices in our study in

    all 3 centers. The nding that mean

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    postductal saturation is higher than

    preductal saturation should be vali-

    dated in other study settings with

    other devices and technology. The

    saturation data were recorded man-

    ually by the nurses who performed

    the screen, leaving room for humanerror during transcription, and sys-

    tematic bias of picking the highest

    number with an intention to pass. A

    more accurate method would be to

    download the pulse oximetry data

    electronically.

    CONCLUSIONS

    Pre- and postductal oxygen saturation

    nomograms from large numbers are

    essential to further rene methodology

    forCCHDscreening.Henceongoingdata

    collection and review of newborn pop-

    ulations screened for CCHD is essential.

    Linkage of the birth hospital data to

    cardiothoracic surgery data sets such

    as STS and IMPACTand to vital statistics

    are essential to accurately identify all

    CCHD cases missed by screening.

    ACKNOWLEDGMENTS

    We thank the postpartum unit nurses

    and nursing and physician leaders at

    allsiteswhoplayedamajorroleinimple-

    menting the screening program. We

    thankBen KieandPoojaRathi(summer

    students),Malchelnil Cormier, and RobinWufor theirhelpwithdatacollection. We

    also thank Neil Finer, MD, Anne de-Wahl

    Granelli, PhD, and Scott Grosse, PhD, for

    their guidance, and Jacqueline Anne

    Noonan, MD, for her comments early

    in our screening program.

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