Cardiac and cerebral hemodynamics with umbilical cord milking compared with early cord clamping: A randomized cluster crossover trial.

OBJECTIVE: A large, randomized cluster cross-over trial (N = 1730) comparing intact umbilical cord milking (UCM) to early cord clamping (ECC) in non-vigorous near-term/term newborns demonstrated a reduction in cardiorespiratory interventions at birth and less moderate to severe hypoxic ischemic encephalopathy. We evaluated changes in cerebral tissue oxygenation (StO2), pulse oximetry (SpO2), pulse rate and fraction of inspired oxygen (FiO2) during the first 10 min of life in a subset of infants enrolled in the parent trial. STUDY DESIGN: Infants enrolled in the Milking in Non-Vigorous Infants trial that had StO2 monitoring at birth were included in the sub-study conducted at 3 hospitals the US and Canada. A near-infrared spectroscopy sensor, pulse oximeter and electrocardiogram electrodes were placed. Pulse rate, StO2, SpO2, and FiO2 were collected for the first 10 min after birth. Longitudinal models were used to compare effects of UCM and ECC. RESULTS: Thirty-four infants had StO2 data. Fifteen of these infants received UCM and 19 had ECC. Infants receiving UCM had similar heart rates, SpO2, and StO2 values, but were exposed to less FiO2 over the first 10 min of life than infants with ECC (0.26 ± 0.12 vs. 0.81 ± 0.05 at 10 min). CONCLUSION: Non-vigorous term/near term infants who received UCM at birth required lower FiO2 after delivery when compared to infants who umbilical cords were clamped soon after birth while achieving similar peripheral and cerebral oxygenation. Cord milking may be a potential option for placental transfusion in non-vigorous near term/term infants when delayed cord clamping cannot be performed.

Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial.

BACKGROUND: Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.

Maternal bleeding complications and neonatal outcomes following early versus delayed umbilical cord clamping in cesarean deliveries for very low birthweight infants.

OBJECTIVE: Determine effect of at least 60 s delayed cord clamping (DCC) on postpartum hemorrhage and maternal estimated blood loss (EBL) in very low birth weight (VLBW) cesarean deliveries when compared to early cord clamping (ECC). STUDY DESIGN: Retrospective study of VLBW infants at birth. Maternal pre- and post-operative hemoglobin, EBL, and neonatal outcomes were collected. RESULTS: In total, 620 VLBW infants (DCC = 166, ECC = 454) born to 545 mothers (DCC = 155, ECC = 390) were included. Maternal PPH between DCC was 8% versus ECC was 10% p = 0.52. There were no differences in estimated blood loss or rate of maternal blood transfusion between groups. The post-operative hemoglobin was lower in infants receiving ECC compared to DCC (10.4 [9.4-11.5] versus 10.8 [10.1-11.9] g/dl, p = 0.01). In comparing pre-operative to post-operative hemoglobin there was no difference between DCC and ECC (-1.2 [-2.0 to -0.3] versus -1.2 [-2.1 to -0.6] g/dl, p = 0.46). CONCLUSION: DCC of at least 60 s did not increase maternal bleeding complications during VLBW cesarean delivery. To our knowledge, this retrospective study is the largest sample size to date of preterm cesarean deliveries to support maternal safety regarding bleeding complications after delayed cord clamping.

Caffeine and Less Invasive Surfactant Administration for Respiratory Distress Syndrome of the Newborn.

BACKGROUND: Management strategies for preterm neonates with respiratory distress syndrome include early initiation of continuous positive airway pressure (CPAP) and titration of fractional inspired oxygen and may include the use of less invasive surfactant administration (LISA) to avoid the need for endotracheal intubation. This randomized trial investigated whether early administration of caffeine and LISA would decrease the need for endotracheal intubation in the first 72 hours of life (HoL) compared with caffeine and CPAP alone. METHODS: Eligible neonates born at 24 weeks 0 days to 29 weeks 6 days of gestational age were randomly assigned to receive intravenous caffeine in the first 2 HoL followed by surfactant administration via the LISA method (intervention) or caffeine followed by CPAP (control). The primary outcome was the frequency of neonates requiring endotracheal intubation or meeting respiratory failure criteria between groups (caffeine and LISA vs. caffeine and CPAP) within the first 72 HoL. Multivariable logistic regression modeling was used to adjust for gestational age strata in normally distributed primary and secondary outcomes. RESULTS: Enrollment occurred between January 2020 and December 2022. Endotracheal intubation or meeting respiratory failure criteria within the first 72 HoL occurred in 21 (23%) of 92 neonates randomly assigned to receive caffeine and LISA compared with 47 (53%) of 88 neonates in the caffeine and CPAP group (odds ratio, 0.258; 95% confidence interval, 0.136 to 0.490; P<0.001), which remained significant after adjusting for gestational age strata (odds ratio, 0.227; 95% confidence interval, 0.112 to 0.460; P<0.001). Adverse events were similar between groups, except bronchopulmonary dysplasia, which occurred in 26% of the LISA group and 39% of the control group (P=0.049). CONCLUSIONS: In preterm neonates supported with CPAP, early caffeine and LISA resulted in a lower frequency of endotracheal intubation within the first 72 HoL. (Funded by Chiesi USA; ClinicalTrials.gov number, NCT04209946.)

Use of Pulse Oximetry Pulsatility Index Screening for Critical Congenital Heart Disease.

OBJECTIVE: This study aimed to compare oximetry data (pre- and postductal oxygen saturation [SpO2], pre- and postductal pulsatility index [PI]) in healthy newborns (≥35 weeks' gestational age) to infants who have critical congenital heart disease (CCHD). STUDY DESIGN: This is a retrospective analysis of data obtained from electronic medical records, recorded as part of routine pulse oximetry screening (POS) for CCHD in infants born between the years 2013 and 2020. Testing was performed at 24 ± 2 hours of life. Data were analyzed to detect differences in pre- and postductal SpO2 and pre- and postductal PI in healthy newborns compared with infants who have CCHD. Newborns were excluded from analysis if they: (1) had a prenatal diagnosis of CCHD in the medical record, (2) had previously been admitted to the neonatal intensive care unit, or (3) had failed POS but were found no CCHD by diagnostic echocardiography. RESULTS: A total of 88,754 healthy newborns had received POS between the years 2013 and 2020. Of the 88,736 newborn records available for analysis,18 newborns were diagnosed with CCHD. Eight were identified by POS before discharge and 10 were diagnosed after discharge. Infants diagnosed with CCHD by POS had lower pre- and postductal SpO2 compared with normal infants. Their postductal PI was significantly lower. Infants who had CCHD that was not identified by POS had similar pre- and postductal SpO2 values, but their postductal PI was lower. Using a postductal PI cutoff of 1.21 had a receiver operating curve of area under the curve 0.77 (95% confidence interval: 0.672, 0.869) with 74% sensitivity and 61% specificity. CONCLUSION: In our large cohort of infants born in San Diego County, the postductal PI is lower in infants with CCHD. Given that PI is routinely displayed on every pulse oximeter and the high morbidity of missed CCHD, PI should be incorporated into routine CCHD screening. KEY POINTS: · Postductal PI is lower in newborn who presented later with congenital heart disease.. · Postductal PI cut-off of 1.21 may help practitioners determine if a newborn is at risk for CCHD.. · This large cohort study demonstrates that a low PI can detect additional CCHD cases..

Two-year neurodevelopmental outcomes of preterm infants who received red blood cell transfusion.

BACKGROUND: Studies aimed at reducing neonatal anaemia or transfusing higher blood volumes did not find improvement in neurodevelopmental function at two years of age. This study investigated the relationship between the receipt, timing, and number of red blood cell (RBC) transfusions and neurodevelopmental outcomes among preterm infants. MATERIALS AND METHODS: This is a retrospective review of preterm infants (gestational age <34 weeks) with a full neurodevelopmental assessment at 18-36 months corrected age from October 2008 to September 2020. Bayley Scales of Infant and Toddler Development, third edition and the Modified Checklist for Autism in Toddlers were collected. Multivariable regressions were used to evaluate neurodevelopmental outcomes. RESULTS: 654 preterm infants were evaluated with a mean follow-up of 25 months. 295 infants (45%) received a total of 1,322 blood transfusions. After adjustment for gestational age, baseline morbidity, and socioeconomic status, receipt of RBC transfusion was associated with decreased two-year cognitive and motor function, but not language (p=0.047, 0.025, and 0.879, respectively). There was no significant difference in outcomes between receipt of transfusion in the first week of life compared to after. Number of transfusions was associated with decreased cognitive, language, and motor function (all p<0.001), and increased likelihood to develop severe neurodevelopmental impairment (adjusted-odds ratio, 1.09; 95% confidence interval, 1.03-1.15; p=0.004). DISCUSSION: Our study demonstrates an association between RBC transfusion and lower cognitive and motor outcomes at two-years after adjustment for prematurity and illness at birth. Increasing number of transfusions worsened neurodevelopmental outcomes.

Long-term neurodevelopmental outcomes among preterm infants born to mothers with diabetes mellitus.

BACKGROUND: The long-term effects of maternal diabetes on preterm infant neurodevelopment are unknown. This study aims to determine if there was an increased likelihood of neurodevelopmental impairment in preterm infants born to mothers with diabetes. MATERIALS AND METHODS: A retrospective cohort study was conducted on preterm infants with neurodevelopmental evaluations at 18-36 months corrected age using the Bayley Scales of Infant and Toddler Development Third edition. RESULTS: 680 former preterm infants were evaluated. There was no difference in cognitive, language, and motor scores. Infants born to diabetic mothers with AMA were significantly different in cognitive (adjusted-ß (a-ß),-7.24 [95%CI, -11.719 to -2.769]; P = 0.002) and language domains (a-ß,-7.783 [95%CI, -13.603 to -1.963]; (P = 0.009). DISCUSSION: There was no significant difference in neurodevelopmental outcomes of preterm infants exposed to maternal diabetes. Preterm infants born to mothers with diabetes and AMA demonstrated lower cognitive and language scores at 2 years corrected age.

Association between early cerebral oxygenation and neurodevelopmental impairment or death in premature infants.

OBJECTIVE: To assess the relationship between cerebral oxygenation in the first 72 h of life and neurodevelopmental impairment (NDI) at 2 years corrected age in former premature infants. STUDY DESIGN: Prospective observational cohort study of 127 infants <32 weeks GA at birth with cerebral oxygenation monitoring using NIRS in the first 72 h of life. RESULTS: Using a threshold cutoff for cerebral hypoxia, infants with NDI or death had increased duration of hypoxia (4 vs 2.3%, p = 0.001), which was more pronounced in the 23-27 week subgroup (7.6 vs 3.2%, p < 0.001). Individual generalized estimating equations to adjust for repeated measures were modeled in this subgroup for the physiologic parameters including StO2. StO2 < 67% was a predictor for death or NDI (OR 2.75, 95% CI 1.006, 7.5132, p = 0.049). CONCLUSION: An increased duration of cerebral hypoxia is associated with NDI or death in infants born <32 weeks GA.

Resuscitation outcomes of infants that do not achieve a 5 min target SpO2 saturation.

OBJECTIVE: To determine differences in the duration and level of resuscitation between infants that achieve a peripheral oxygen saturation (SpO2) of 80% by 5 min compared with those who remain below 80% saturation. STUDY DESIGN: Infants < 32 weeks GA were analyzed. Pulse rate, SpO2, airway pressure, and fraction of inspired oxygen were collected during the first 10 min of life. RESULTS: Two hundred and eighty-four infants were analyzed of which 100 had SpO2 < 80% at 5 min of life. Composite outcome of death and any IVH was greater in the <80% at 5 min group. These infants had lower heart rates and lower SpO2 despite increased mean airway pressure and higher FiO2 (p < 0.001). CONCLUSION: Infants <32 weeks GA that do not achieve a peripheral arterial saturation of 80% by 5 min of life experience more death or severe IVH. This association is amongst the strongest seen of any predictor of morbidity in the delivery room.

Acceptability of Bedside Resuscitation With Intact Umbilical Cord to Clinicians and Patients' Families in the United States.

BACKGROUND: While delayed umbilical cord clamping in preterm infants has shown to improve long-term neurological outcomes, infants who are thought to need resuscitation do not receive delayed cord clamping even though they may benefit the most. A mobile resuscitation platform allows infants to be resuscitated at the mother's bedside with the cord intact. The newborn is supplied with placental blood during the resuscitation in view of the mother. The objective of the study is to assess the usability and acceptability of mobile resuscitation platform, LifeStart trolley, among the infants' parents and perinatal providers. METHODS: A resuscitation platform was present during every delivery that required advanced neonatal providers for high-risk deliveries. Perinatal providers and parents of the infants were given a questionnaire shortly after the delivery. RESULTS: 60 neonatal subjects were placed on the trolley. The majority of deliveries were high risk for meconium-stained amniotic fluid (43%), and non-reassuring fetal heart rate (45%). About 50% of neonatal providers felt that there were some concerns regarding access to the baby. No parents were uncomfortable with the bedside neonatal interventions, and most parents perceived that communication was improved because of the proximity to the care team. CONCLUSION: Bedside resuscitation with umbilical cord intact through the use of a mobile resuscitation trolley is feasible, safe, and effective, but about half of the perinatal providers expressed concerns. Logistical issues such as improved space management and/or delivery setup should be considered in centers planning to perform neonatal resuscitation with an intact cord.

Maternal bleeding complications following early versus delayed umbilical cord clamping in multiple pregnancies.

BACKGROUND: In 2015, the American Academy of Pediatrics recommended delayed umbilical cord clamping for at least 30-60 s for all infants. However, there is limited data regarding the maternal safety of delayed cord clamping in multiple pregnancies. We aimed to compare the maternal bleeding complications following early cord clamping (ECC) versus of delayed cord clamping (DCC) in multiple pregnancies. METHODS: A retrospective cohort study of pregnant women with multiples who delivered live-born infants at Sharp Healthcare Hospitals in San Diego, CA, USA during January 1st, 2016 - September 30th, 2017. Bleeding complications of 295 women who underwent ECC (less than 30 s) were compared with 154 women who underwent DCC (more than 30 s). ECC or DCC was performed according to individual obstetrician discretion. RESULTS: Four hundred forty-nine women with multiple pregnancies (N = 910 infants) were included in the study. 252 (85.4%) women underwent cesarean section in ECC group vs. 99 (64.3%) in DCC group. 58 (19.7%) women delivered monochorionic twins in ECC group vs. 32 (20.8%) women in DCC group. There was no increase in maternal estimate blood loss when DCC was performed comparing to ECC. There were no differences in operative time, post-delivery decrease in hematocrits, rates of postpartum hemorrhage, bleeding complications, maternal blood transfusions and therapeutic hysterectomy between the two groups. CONCLUSIONS: No differences in maternal bleeding complications were found with DCC in multiple pregnancies compared to ECC. Delayed cord clamping can be done safely in multiple pregnancies without any increased maternal risk.

The Neu-Prem Trial: Neuromonitoring of Brains of Infants Born Preterm During Resuscitation-A Prospective Observational Cohort Study.

OBJECTIVE: To determine whether monitoring cerebral oxygen tissue saturation (StO2) with near-infrared spectroscopy (NIRS) and brain activity with amplitude-integrated electroencephalography (aEEG) can predict infants at risk for intraventricular hemorrhage (IVH) and death in the first 72 hours of life. STUDY DESIGN: A NIRS sensor and electroencephalography leads were placed on 127 newborns <32 weeks of gestational age at birth. Ten minutes of continuous NIRS and aEEG along with heart rate, peripheral arterial oxygen saturation, fraction of inspired oxygen, and mean airway pressure measurements were obtained in the delivery room. Once the infant was transferred to the neonatal intensive care unit, NIRS, aEEG, and vital signs were recorded until 72 hours of life. An ultrasound scan of the head was performed within the first 12 hours of life and again at 72 hours of life. RESULTS: Thirteen of the infants developed any IVH or died; of these, 4 developed severe IVH (grade 3-4) within 72 hours. There were no differences in either cerebral StO2 or aEEG in the infants with low-grade IVH. Infants who developed severe IVH or death had significantly lower cerebral StO2 from 8 to 10 minutes of life. CONCLUSIONS: aEEG was not predictive of IVH or death in the delivery room or in the neonatal intensive care unit. It may be possible to use NIRS in the delivery room to predict severe IVH and early death. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02605733.

A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age.

OBJECTIVE: To compare the effect of umbilical cord milking vs delayed cord clamping (DCC) on neurodevelopmental and health outcomes in very preterm infants at 22-26 months of corrected age. STUDY DESIGN: Neurodevelopmental outcomes at 2 years of age were assessed using the Bayley Scales of Infant Development, third edition, and a standardized neurologic examination. Data regarding pulmonary morbidities, neurosensory impairments, and hospitalizations were obtained by parental interview. Intention-to-treat was used for primary analyses. RESULTS: Of the 197 infants enrolled in the original study there were 15 deaths, 5 in the umbilical cord milking group and 10 in DCC group. Of the remaining infants, 135 (74%) were assessed at 22-26 months of corrected age. Demographics in umbilical cord milking (n = 70) and DCC (n = 65) groups were similar. Infants randomized to umbilical cord milking at birth had significantly higher cognitive and language composite scores, and were less likely to have a cognitive composite score of <85 (4% vs 15%; P = .04). Motor function was similar in both groups. There were no differences in the incidences of mild or moderate to severe neurodevelopmental impairment, hearing or visual impairments, pulmonary morbidities, or rehospitalizations between the 2 groups. CONCLUSIONS: Infants randomized to umbilical cord milking had higher language and cognitive scores compared with those randomized to DCC. There was no difference in rates of mild or moderate to severe neurodevelopmental impairment. TRIAL REGISTRATION: clinicaltrials.gov: NCT01434732.

Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial.

OBJECTIVE: To assess whether providing ventilation during delayed cord clamping (V-DCC) increases placental transfusion compared with delayed cord clamping alone (DCC only). STUDY DESIGN: Inborn premature infants (230/7-316/7 weeks' gestational age) were randomized to receive at least 60 seconds of V-DCC (initial continuous positive airway pressure) with addition of positive pressure ventilation if needed) or without assisted ventilation (DCC only). For the DCC-only group, infants were dried and stimulated by gently rubbing the back if apneic. The primary outcome was the peak hematocrit in the first 24 hours of life. Delivery room outcomes were analyzed from video recordings and a data acquisition system. Hemodynamic measurements were performed with the use of functional echocardiography, near-infrared spectroscopy, and electrical cardiometry. RESULTS: There was no difference in the primary outcome of peak hematocrit in the first 24 hours of life. The onset of breathing was similar between both groups (25 ± 20 and 27 ± 28 seconds, P = .627); however, infants receiving DCC received a greater duration of stimulation than V-DCC (41 ± 19 and 20 ± 21 seconds P = .002). There were no differences in delivery room interventions, early hemodynamics (cerebral oxygenation by near-infrared spectroscopy, cardiac output and stroke volume by electrical cardiometry, or superior vena cava flow by of functional echocardiography), or neonatal outcomes. CONCLUSIONS: V-DCC was feasible but did not lead to any measurable clinical improvements immediately after delivery or reduce subsequent neonatal morbidity. Caretakers should consider providing adequate stimulation before cord clamping. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02231411.

Resistance of Colorimetric Carbon Dioxide Detectors Commonly Utilized in Neonates.

BACKGROUND: Colorimetric end-tidal carbon dioxide (ETCO2) detectors can identify airway obstruction during noninvasive ventilation and successful intubation during newborn resuscitation. The resistance of these devices is not well described, and the information provided by manufacturers is incomplete. METHODS: We compared the resistance of 3 colorimetric ETCO2 detectors (Neo-StatCO2, Pedi-Cap, and Mini StatCO2,) and 2 mainstream capnograph sensors (EMMA infant airway adapter 17449 and neonatal/infant airway adapter YG-213T). Endotracheal tubes, 2.5-4.0-mm inner diameter (Portex) were measured as a reference range. A differential pressure transducer was placed between the device and a T-piece resuscitator. The other side of the device was open to air. Resistance to flow was tested at 1-10 L/min. Resistance was calculated as the change in pressure over change in flow and expressed as cm H2O/L/s. RESULTS: There was a significantly higher mean resistance across all flows tested for the Neo-StatCO2 compared with the other ETCO2 devices (P < .001). There was a 6-fold difference between the least and most resistive colorimetric detectors. At the commonly utilized flow of 10 L/min, the resistance of the Neo-StatCO2 was 61.1 cm H2O/L/s, comparable with that of a 3.0 endotracheal tube, which we measured at 62.7 cm H2O/L/s. The resistance values of the Pedi-Cap and Mini StatCO2 were 9.9 and 8.4 cm H2O/L/s, respectively. Those of the EMMA and YG-213T were 7.1 and 2.6 cm H2O/L/s, respectively. CONCLUSIONS: We found significant differences in resistance between devices used to detect ETCO2 during resuscitation of premature infants. Future trials are needed to determine the effects of this resistance on work of breathing, particularly on very premature newborns receiving mask CPAP.

Measuring severe maternal morbidity: validation of potential measures.

BACKGROUND: Both maternal mortality rate and severe maternal morbidity rate have risen significantly in the United Sates. Recently, the Centers for Disease Control and Prevention introduced International Classification of Diseases, 9th revision, criteria for defining severe maternal morbidity with the use of administrative data sources; however, those criteria have not been validated with the use of chart reviews. OBJECTIVE: The primary aim of the current study was to validate the Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria for the identification of severe maternal morbidity. This analysis initially required the development of a reproducible set of clinical conditions that were judged to be consistent with severe maternal morbidity to be used as the clinical gold standard for validation. Alternative criteria for severe maternal morbidity were also examined. STUDY DESIGN: The 67,468 deliveries that occurred during a 12-month period from 16 participating California hospitals were screened initially for severe maternal morbidity with the presence of any of 4 criteria: (1) Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, diagnosis and procedure codes; (2) prolonged postpartum length of stay (>3 standard deviations beyond the mean length of stay for the California population); (3) any maternal intensive care unit admissions (with the use of hospital billing sources); and (4) the administration of any blood product (with the use of transfusion service data). Complete medical records for all screen-positive cases were examined to determine whether they satisfied the criteria for the clinical gold standard (determined by 4 rounds of a modified Delphi technique). Descriptive and statistical analyses that included area under the receiver operating characteristic curve and C-statistic were performed. RESULTS: The Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria had a reasonably high sensitivity of 0.77 and a positive predictive value of 0.44 with a C-statistic of 0.87. The most important source of false-positive cases were mothers whose only criterion was 1-2 units of blood products. The Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria screen rate ranged from 0.51-2.45% among hospitals. True positive severe maternal morbidity ranged from 0.05-1.13%. When hospitals were grouped by their neonatal intensive care unit level of care, severe maternal morbidity rates were statistically lower at facilities with lower level neonatal intensive care units (P < .0001). CONCLUSION: The Centers for Disease Control and Prevention International Classification of Diseases, 9th revision, criteria can serve as a reasonable administrative metric for measuring severe maternal morbidity at population levels. Caution should be used with the use of these criteria for individual hospitals, because case-mix effects appear to be strong.

An exploratory analysis of the utility of adding cardiorespiratory biofeedback in the standard care of pregnancy-induced hypertension.

This study examined the efficacy of a cardiorespiratory biofeedback intervention compared to bed rest in the treatment of 47 women diagnosed with pregnancy-induced hypertension (PIH). The investigation consisted of a historical control group with 31 PIH subjects receiving treatment as usual (TAU), bed rest and antihypertensive medications, and an experimental group with 16 PIH subjects receiving TAU and instruction on using a portable respiratory sinus arrhythmia (RSA) biofeedback device once daily until delivery. Results indicated that systolic and diastolic blood pressure levels were unchanged for either group. Failing to find the intended main effects, a series of exploratory analyses were performed. Findings of associated hypotheses revealed that the RSA BF group had a 35 % higher birth weight than the TAU group. The gestational age at delivery was 10 % greater in the RSA BF group than in the TAU group. A significant relationship was found between the StressEraser Total and the 1-min Apgar score. Eighty-one percent of the subjects stated that the device was relaxing. Fifty percent of the subjects believed that the device helped them fall asleep. Overall, these results suggest that portable RSA biofeedback may be effective in reducing stress during pregnancy and improving perinatal outcomes.

Increasing exclusive breastfeeding rates in the well-baby population: an evidence-based change project.

This article describes an evidence-based project that increased the rate of exclusive breastfeeding in a well-baby population by providing breastfeeding basics to nursing staff on the Mother Infant Services (MIS) units. The clinical implications are that nurses' attitudes and care significantly influence exclusive breastfeeding rates. We contend that resources should be allocated to provide nurses with current evidence-based breastfeeding education.

Nonstress testing at ≤ 32.0 weeks' gestation: a randomized trial comparing different assessment criteria.

OBJECTIVE: Comparison of time and outcomes of National Institutes of Child Health and Human Development defined fetal heart rate acceleration criteria at ≤ 32 weeks (≥ 10 beats/min, ≥ 10 seconds) compared with standard criteria (≥ 15 beats/min, ≥ 15 seconds). STUDY DESIGN: Singleton high-risk pregnancies that were referred for nonstress testing at ≤ 32 weeks' gestation were randomly assigned to 15 × 15 or 10 × 10 criteria. Data included nonstress test information, maternal data, and outcomes. RESULTS: One hundred forty-three women were randomly assigned to 15 × 15 (n = 71) or 10 × 10 (n = 72). The groups were similar in maternal and pregnancy characteristics. Median time to reactive nonstress testing was shorter in the 10 × 10 group (37.3 minutes) than the 15 × 15 group (41.3 minutes; P = .04). There were no serious adverse events. CONCLUSION: The time to attain a reactive nonstress testing at ≤ 32 weeks' gestation was 4 minutes shorter when the 10 × 10 criteria were used. There were no adverse events related to use of 10 × 10 nonstress testing criteria.