Outcomes of Babies with Opioid Exposure (OBOE): protocol of a prospective longitudinal cohort study.

2023

1772-1779

05/2023

1530-0447

BACKGROUND: While the health, social, and economic impacts of opioid addiction on adults and their communities are well known, the impact of maternal opioid use on the fetus exposed in utero is less well understood.

METHODS: This paper presents the protocol of the ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study, a multi-site prospective longitudinal cohort study of infants with antenatal opioid exposure and unexposed controls. Study objectives are to determine the impact of antenatal opioid exposure on brain development and neurodevelopmental outcomes over the first 2 years of life and explore whether family, home, and community factors modify developmental trajectories during this critical time period.

RESULTS: Primary outcomes related to brain development include cortical volumes, deep cerebral gray matter volumes, resting-state functional connectivity measures, and structural connectivity measures using diffusion tensor imaging. Primary neurodevelopmental outcomes include visual abnormalities, cognitive, language, and motor skills measured using the Bayley Scales of Infant Development and social-emotional and behavioral problems and competence measured by the Brief Infant-Toddler Social and Emotional Assessment.

CONCLUSIONS: The OBOE study has been designed to overcome challenges of previous studies and will help further understanding of the effects of antenatal opioid exposure on early infant development.

IMPACT: This study will integrate MRI findings and comprehensive neurodevelopmental assessments to provide early insights into the functional topography of the brain in this high-risk population and assess MRI as a potential biomarker. Rather than conducting neuroimaging at a single time point, the study will include serial MRI assessments from birth to 2 years, allowing for the examination of trajectories throughout this period of rapid brain development. While previous studies often have had limited information on exposures, this study will use umbilical cord assays to accurately measure amounts of opioids and other substances from 20 weeks of gestation to birth.

10.1038/s41390-022-02279-2

Pediatr Res

36042329

Outcomes of Babies with Opioid Exposure (OBOE): protocol of a prospective longitudinal cohort study.

2023

1772-1779

05/2023

1530-0447

BACKGROUND: While the health, social, and economic impacts of opioid addiction on adults and their communities are well known, the impact of maternal opioid use on the fetus exposed in utero is less well understood.

METHODS: This paper presents the protocol of the ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study, a multi-site prospective longitudinal cohort study of infants with antenatal opioid exposure and unexposed controls. Study objectives are to determine the impact of antenatal opioid exposure on brain development and neurodevelopmental outcomes over the first 2 years of life and explore whether family, home, and community factors modify developmental trajectories during this critical time period.

RESULTS: Primary outcomes related to brain development include cortical volumes, deep cerebral gray matter volumes, resting-state functional connectivity measures, and structural connectivity measures using diffusion tensor imaging. Primary neurodevelopmental outcomes include visual abnormalities, cognitive, language, and motor skills measured using the Bayley Scales of Infant Development and social-emotional and behavioral problems and competence measured by the Brief Infant-Toddler Social and Emotional Assessment.

CONCLUSIONS: The OBOE study has been designed to overcome challenges of previous studies and will help further understanding of the effects of antenatal opioid exposure on early infant development.

IMPACT: This study will integrate MRI findings and comprehensive neurodevelopmental assessments to provide early insights into the functional topography of the brain in this high-risk population and assess MRI as a potential biomarker. Rather than conducting neuroimaging at a single time point, the study will include serial MRI assessments from birth to 2 years, allowing for the examination of trajectories throughout this period of rapid brain development. While previous studies often have had limited information on exposures, this study will use umbilical cord assays to accurately measure amounts of opioids and other substances from 20 weeks of gestation to birth.

10.1038/s41390-022-02279-2

Pediatr Res

36042329

Psychometric Properties of the Prenatal Opioid Use Perceived Stigma Scale and Its Use in Prenatal Care.

2023

150-158

03/2023

1552-6909

OBJECTIVE: To examine the psychometric properties of the Prenatal Opioid Use Perceived Stigma (POPS) scale and to assess the relationship of POPS scores to adequate prenatal care.

DESIGN: Prospective cohort study.

SETTING: Medical centers in Alabama, Ohio, and Pennsylvania (N = 4).

PARTICIPANTS: Women (N = 127) who took opioids during pregnancy and whose infants participated in the Outcomes of Babies With Opioid Exposure Study.

METHODS: Participants reported their perceptions of stigma during pregnancy by responding to the eight items on the POPS scale. We evaluated the instrument's internal consistency reliability (Cronbach's alpha), structural validity (factor analysis), and convergent validity (relationship with measures of similar constructs). In addition, to assess construct validity, we used logistic regression to examine the relationship of POPS scores to the receipt of adequate prenatal care.

RESULTS: The internal consistency of the POPS scale was high (Cronbach's α = .88), and all item-total correlations were greater than 0.50. The factor analysis confirmed that the items cluster into one factor. Participants who reported greater perceived stigma toward substance users and everyday discrimination in medical settings had higher POPS scores, which supported the convergent validity of the scale. POPS scores were significantly associated with not receiving adequate prenatal care, adjusted OR = 1.47, 95% confidence interval [1.19, 1.83], p < .001.

CONCLUSION: The psychometric testing of the POPS scale provided initial support for the reliability and validity of the instrument. It may be a useful tool with which to assess perceived stigma among women who take opioids, a potential barrier to seeking health care during pregnancy.

10.1016/j.jogn.2022.12.002

J Obstet Gynecol Neonatal Nurs

36696952

Psychometric Properties of the Prenatal Opioid Use Perceived Stigma Scale and Its Use in Prenatal Care.

2023

01/2023

1552-6909

OBJECTIVE: To examine the psychometric properties of the Prenatal Opioid Use Perceived Stigma (POPS) scale and to assess the relationship of POPS scores to adequate prenatal care.

DESIGN: Prospective cohort study.

SETTING: Medical centers in Alabama, Ohio, and Pennsylvania (N = 4).

PARTICIPANTS: Women (N = 127) who took opioids during pregnancy and whose infants participated in the Outcomes of Babies With Opioid Exposure Study.

METHODS: Participants reported their perceptions of stigma during pregnancy by responding to the eight items on the POPS scale. We evaluated the instrument's internal consistency reliability (Cronbach's alpha), structural validity (factor analysis), and convergent validity (relationship with measures of similar constructs). In addition, to assess construct validity, we used logistic regression to examine the relationship of POPS scores to the receipt of adequate prenatal care.

RESULTS: The internal consistency of the POPS scale was high (Cronbach's α = .88), and all item-total correlations were greater than 0.50. The factor analysis confirmed that the items cluster into one factor. Participants who reported greater perceived stigma toward substance users and everyday discrimination in medical settings had higher POPS scores, which supported the convergent validity of the scale. POPS scores were significantly associated with not receiving adequate prenatal care, adjusted OR = 1.47, 95% confidence interval [1.19, 1.83], p < .001.

CONCLUSION: The psychometric testing of the POPS scale provided initial support for the reliability and validity of the instrument. It may be a useful tool with which to assess perceived stigma among women who take opioids, a potential barrier to seeking health care during pregnancy.

10.1016/j.jogn.2022.12.002

J Obstet Gynecol Neonatal Nurs

36696952

Outcomes of Babies with Opioid Exposure (OBOE): protocol of a prospective longitudinal cohort study.

2022

08/2022

1530-0447

BACKGROUND: While the health, social, and economic impacts of opioid addiction on adults and their communities are well known, the impact of maternal opioid use on the fetus exposed in utero is less well understood.

METHODS: This paper presents the protocol of the ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study, a multi-site prospective longitudinal cohort study of infants with antenatal opioid exposure and unexposed controls. Study objectives are to determine the impact of antenatal opioid exposure on brain development and neurodevelopmental outcomes over the first 2 years of life and explore whether family, home, and community factors modify developmental trajectories during this critical time period.

RESULTS: Primary outcomes related to brain development include cortical volumes, deep cerebral gray matter volumes, resting-state functional connectivity measures, and structural connectivity measures using diffusion tensor imaging. Primary neurodevelopmental outcomes include visual abnormalities, cognitive, language, and motor skills measured using the Bayley Scales of Infant Development and social-emotional and behavioral problems and competence measured by the Brief Infant-Toddler Social and Emotional Assessment.

CONCLUSIONS: The OBOE study has been designed to overcome challenges of previous studies and will help further understanding of the effects of antenatal opioid exposure on early infant development.

IMPACT: This study will integrate MRI findings and comprehensive neurodevelopmental assessments to provide early insights into the functional topography of the brain in this high-risk population and assess MRI as a potential biomarker. Rather than conducting neuroimaging at a single time point, the study will include serial MRI assessments from birth to 2 years, allowing for the examination of trajectories throughout this period of rapid brain development. While previous studies often have had limited information on exposures, this study will use umbilical cord assays to accurately measure amounts of opioids and other substances from 20 weeks of gestation to birth.

10.1038/s41390-022-02279-2

Pediatr Res

36042329

Racial/Ethnic Disparities Among Extremely Preterm Infants in the United States From 2002 to 2016.

2020

e206757

2020 Jun 01

2574-3805

<p><strong>Importance: </strong>Racial/ethnic disparities in quality of care among extremely preterm infants are associated with adverse outcomes.</p>

<p><strong>Objective: </strong>To assess whether racial/ethnic disparities in major outcomes and key care practices were changing over time among extremely preterm infants.</p>

<p><strong>Design, Setting, and Participants: </strong>This observational cohort study used prospectively collected data from 25 US academic medical centers. Participants included 20 092 infants of 22 to 27 weeks' gestation with a birth weight of 401 to 1500 g born at centers participating in the National Institute of Child Health and Human Development Neonatal Research Network from 2002 to 2016. Of these infants, 9316 born from 2006 to 2014 were eligible for follow-up at 18 to 26 months' postmenstrual age (excluding 5871 infants born before 2006, 2594 infants born after 2014, and 2311 ineligible infants including 64 with birth weight &gt;1000 g and 2247 infants with gestational age &gt;26 6/7 weeks), of whom 745 (8.0%) did not have known follow-up outcomes at 18 to 26 months.</p>

<p><strong>Main Outcomes and Measures: </strong>Rates of mortality, major morbidities, and care practice use over time were evaluated using models adjusted for baseline characteristics, center, and birth year. Data analyses were conducted from 2018 to 2019.</p>

<p><strong>Results: </strong>In total, 20 092 infants with a mean (SD) gestational age of 25.1 (1.5) weeks met the inclusion criteria and were available for the primary outcome: 8331 (41.5%) black infants, 3701 (18.4%) Hispanic infants, and 8060 (40.1%) white infants. Hospital mortality decreased over time in all groups. The rate of improvement in hospital mortality over time did not differ among black and Hispanic infants compared with white infants (black infants went from 35% to 24%, Hispanic infants went from 32% to 27%, and white infants went from 30% to 22%; P = .59 for race × year interaction). The rates of late-onset sepsis among black infants (went from 37% to 24%) and Hispanic infants (went from 45% to 23%) were initially higher than for white infants (went from 36% to 25%) but decreased more rapidly and converged during the most recent years (P = .02 for race × year interaction). Changes in rates of other major morbidities did not differ by race/ethnicity. Death before follow-up decreased over time (from 2006 to 2014: black infants, 14%; Hispanic infants, 39%, white infants, 15%), but moderate-severe neurodevelopmental impairment increased over time in all racial/ethnic groups (increase from 2006 to 2014: black infants, 70%; Hispanic infants, 123%; white infants, 130%). Rates of antenatal corticosteroid exposure (black infants went from 72% to 90%, Hispanic infants went from 73% to 83%, and white infants went from 86% to 90%; P = .01 for race × year interaction) and of cesarean delivery (black infants went from 45% to 59%, Hispanic infants went from 49% to 59%, and white infants went from 62% to 63%; P = .03 for race × year interaction) were initially lower among black and Hispanic infants compared with white infants, but these differences decreased over time.</p>

<p><strong>Conclusions and Relevance: </strong>Among extremely preterm infants, improvements in adjusted rates of mortality and most major morbidities did not differ by race/ethnicity, but rates of neurodevelopmental impairment increased in all groups. There were narrowing racial/ethnic disparities in important care practices, including the use of antenatal corticosteroids and cesarean delivery.</p>

10.1001/jamanetworkopen.2020.6757

JAMA Netw Open

32520359

Home Oxygen and 2-Year Outcomes of Preterm Infants With Bronchopulmonary Dysplasia.

2019

2019 05

1098-4275

<p><strong>OBJECTIVES: </strong>To compare medical and developmental outcomes over the first 2 years of life in extremely preterm infants with bronchopulmonary dysplasia (BPD) who were discharged on supplemental oxygen via nasal cannula with outcomes of infants with a similar severity of respiratory illness who were discharged breathing in room air.</p>

<p><strong>METHODS: </strong>We performed a propensity score-matched cohort study. Eligible infants were born at &lt;27 weeks' gestation, were receiving supplemental oxygen or respiratory support at 36 weeks' postmenstrual age, and were assessed at 18 to 26 months' corrected age. Study outcomes included growth, resource use, and neurodevelopment between discharge and follow-up. Outcomes were compared by using multivariable models adjusted for center and age at follow-up.</p>

<p><strong>RESULTS: </strong>A total of 1039 infants discharged on supplemental oxygen were propensity score matched 1:1 to infants discharged breathing in room air. Infants on oxygen had a marginal improvement in weight score (adjusted mean difference 0.11; 95% confidence interval [CI] 0.00 to 0.22), with a significantly improved weight-for-length score (adjusted mean difference 0.13; 95% CI 0.06 to 0.20) at 22 to 26 months' corrected age. Infants on oxygen were more likely to be rehospitalized for respiratory illness (adjusted relative risk 1.33; 95% CI 1.16 to 1.53) and more likely to use respiratory medications and equipment. Rates of neurodevelopmental impairment were similar between the groups.</p>

<p><strong>CONCLUSIONS: </strong>In this matched cohort of infants with BPD, postdischarge oxygen was associated with marginally improved growth and increased resource use but no difference in neurodevelopmental outcomes. Ongoing and future trials are critical to assess the efficacy and safety of postdischarge supplemental oxygen for infants with BPD.</p>

10.1542/peds.2018-2956

Pediatrics

30975699