Effect of the INSIGHT Responsive Parenting Intervention on Parenting and Child Behavior at Ages 3 and 6 Years.

OBJECTIVES: To examine effects of the INSIGHT study responsive parenting (RP) intervention on reported and observed general parenting and child behavior during early and middle childhood. STUDY DESIGN: Primiparous mother-newborn dyads (n = 279) were randomized to RP intervention or a safety control, with intervention content delivered at research nurse home visits at infant ages 3-4, 16, 28, and 40 weeks and research center visits at 1 and 2 years. At age 3 (n = 220) and 6 years (n = 171) parenting and child behavior were observed during dyadic interactions and coded using the Iowa Family Interaction Rating Scales. Mothers also reported on child behavior (age 3) and aspects of general parenting (age 6) via the Child Behavior Checklist and The Comprehensive General Parenting Questionnaire, respectively. RESULTS: RP group children had fewer mother-reported externalizing (F = 8.69, P = .004) and problem behaviors at age 3 (F = 4.53, P = .03), and higher observed prosocial (F = 4.73, P = .03) and lower antisocial (ie, externalizing; F = 4.79, P = .03) behavior at age 6 vs controls. There were no study group differences in observed maternal sensitivity at age 3 or 6 years. At age 6, RP group mothers reported higher use of structure defined by establishing consistent rules and routines (F = 5.45, P = .02) and organization of their child's environment (F = 7.12, P = .008) compared with controls. CONCLUSIONS: The INSIGHT RP intervention increased parental organization of the child's environment to facilitate competence, and had beneficial impacts on child behavior at 3 and 6 years. No impacts were found on maternal sensitivity in childhood. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01167270.

Bottleneck and selection in the germline and maternal age influence transmission of mitochondrial DNA in human pedigrees.

Heteroplasmy-the presence of multiple mitochondrial DNA (mtDNA) haplotypes in an individual-can lead to numerous mitochondrial diseases. The presentation of such diseases depends on the frequency of the heteroplasmic variant in tissues, which, in turn, depends on the dynamics of mtDNA transmissions during germline and somatic development. Thus, understanding and predicting these dynamics between generations and within individuals is medically relevant. Here, we study patterns of heteroplasmy in 2 tissues from each of 345 humans in 96 multigenerational families, each with, at least, 2 siblings (a total of 249 mother-child transmissions). This experimental design has allowed us to estimate the timing of mtDNA mutations, drift, and selection with unprecedented precision. Our results are remarkably concordant between 2 complementary population-genetic approaches. We find evidence for a severe germline bottleneck (7-10 mtDNA segregating units) that occurs independently in different oocyte lineages from the same mother, while somatic bottlenecks are less severe. We demonstrate that divergence between mother and offspring increases with the mother's age at childbirth, likely due to continued drift of heteroplasmy frequencies in oocytes under meiotic arrest. We show that this period is also accompanied by mutation accumulation leading to more de novo mutations in children born to older mothers. We show that heteroplasmic variants at intermediate frequencies can segregate for many generations in the human population, despite the strong germline bottleneck. We show that selection acts during germline development to keep the frequency of putatively deleterious variants from rising. Our findings have important applications for clinical genetics and genetic counseling.

Adverse Events Related to Accidental Unintentional Ingestions From Cough and Cold Medications in Children.

OBJECTIVES: Previous research has demonstrated that accidental unsupervised ingestions (AUIs) were responsible for the majority of cough and cold medication (CCM) ingestions leading to significant adverse events (AEs) in children. The objective of this analysis was to characterize the role of AUIs in the morbidity associated with CCM exposure in children. METHODS: This surveillance study collected data from 5 United States data sources from 2009 to 2016, in children younger than 6 years with an AE from an AUI involving at least 1 CCM over-the-counter pharmaceutical ingredient. An expert panel reviewed each case to determine causality. RESULTS: From 4756 total cases reviewed, 3134 (65.9%) had an AE from an AUI determined to be at least potentially related to a CCM ingredient. The majority (61.3%) of cases occurred in children aged 2 to younger than 4 years. Most exposures occurred in the child's own residence (94.9%), and 43.8% were admitted to a health care facility (22.0% to a critical care unit). Dextromethorphan and diphenhydramine, when packaged alone or in combination products, contributed to 96.0% of AUIs. The most common specific products involved were single-ingredient pediatric liquid diphenhydramine (30.1%) and single-ingredient pediatric liquid dextromethorphan (21.4%). There were 3 deaths from solid diphenhydramine formulations. CONCLUSIONS: There continues to be opportunities for the implementation of interventions to prevent AUIs of CCM in children. Additional emphasis on engineering controls, such as flow restrictors for liquid formulations targeting diphenhydramine and dextromethorphan products, represent additional opportunities to further reduce AEs from AUIs of CCM.

Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial.

BACKGROUND: Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on health outcomes. OBJECTIVE: This study aimed to determine whether prepregnancy weight loss reduces gestational weight gain and improves pregnancy outcomes. STUDY DESIGN: Pragmatic randomized clinical trial was conducted between May 2015 and October 2019 at Kaiser Permanente Northwest, an integrated health system. Data collection was blind to condition assignment. Eligible participants were women aged 18 to 40 years with a body mass index of ≥27 kg/m2 who were planning pregnancy within 2 years. Recruitment contacts were sent to 27,665 health system members who met age and body mass index criteria; 329 women attended screening visits, and 326 were randomized. They were randomized to either a behavioral weight loss intervention or usual care control. The intervention consisted of health coaching phone sessions weekly for 6 months and then monthly for 18 months or until end of pregnancy. We used logistic regression to examine the a priori primary hypothesis that participants in the intervention would be less likely to exceed National Academy of Medicine guidelines for gestational weight gain during each trimester and overall. Secondary and exploratory outcomes included absolute weight gain before and during pregnancy and perinatal and newborn outcomes. RESULTS: Of the 326 participants, 169 had singleton pregnancies lasting ≥14 weeks (analytical cohort: intervention, 89; control, 80). At baseline, mean age was 31.3±3.5 years, and body mass index was 34.8±5.8 kg/m2. Participants in the intervention group lost more weight before pregnancy than those in the control group (-0.25±0.51 vs -0.03±0.21 kg/wk; P<.001). However, participants in the intervention group gained more weight than those in the control group in the second trimester (0.42±0.26 vs 0.33±0.28 kg/wk; P=.04) and third trimester (0.56±0.37 vs 0.43±0.33 kg/wk; P=.02) and overall (13.2±8.20 vs 10.3±7.41 kg; P=.03). Nevertheless, arms did not differ in rates of exceeding gestational weight gain guidelines at any time point. Spontaneous pregnancy loss was less common in the intervention arm than in the control arm (8 [4.9%] vs 19 [11.8%]; odds ratio, 0.39 [0.16-0.92]), but we found no other differences in the secondary or exploratory outcomes. CONCLUSION: Participation in the prepregnancy weight loss intervention had no effect on women's likelihood of exceeding gestational weight gain guidelines. Although the intervention group successfully lost weight before conception, the intervention group was associated with greater weight gain in late pregnancy. To effectively reduce weight throughout pregnancy and improve maternal and child outcomes, prepregnancy weight loss interventions may need to be combined with intensive weight management that continues throughout delivery.

INSIGHT responsive parenting intervention effects on child appetite and maternal feeding practices through age 3 years.

Expert guidance encourages interventions promoting structure-based practices to establish predictable eating environments in order to foster children's self-regulatory skills. However, few studies have examined whether and how child characteristics may moderate effects of interventions on maternal feeding practices. This analysis aimed to examine the effect of the INSIGHT Responsive Parenting (RP) intervention delivered largely during infancy, on child appetitive traits at 2.5 years and maternal feeding practices at 3 years. Primiparous mother-newborn dyads were randomized to a RP intervention designed for obesity prevention or a safety control intervention. Mothers completed the Child Eating Behavior Questionnaire at 2.5 years and the Structure and Control in Parent Feeding Questionnaire at 3 years. T-tests assessed study group differences on child appetitive traits at 2.5 years and maternal feeding practices at age 3. ANCOVA models assessed the effect of study group on parent feeding practices and tested appetitive traits as a moderator. Two hundred thirty-two mother-child dyads completed the trial. Mothers were predominantly white, non-Hispanic, college educated, and married. RP group mothers used more consistent meal routines, and less pressure, food to soothe, and food as reward compared to controls. Child satiety responsiveness moderated the RP intervention effect on maternal use of limiting exposure to unhealthy foods such that the RP intervention was most effective for children at higher levels of satiety responsiveness. Food responsiveness moderated RP intervention effects on maternal use of pressure, such that at lower levels of food responsiveness, control group mothers used more pressure than RP mothers. The INSIGHT RP intervention demonstrated sustained effects on maternal feeding practices through age 3 years, with some intervention effects showing moderation by child appetitive traits.

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Responsive Parenting Intervention for Firstborns Affects Dietary Intake of Secondborn Infants.

BACKGROUND: Although previous work has shown that children with older siblings tend to have poorer diet quality, no study has directly compared diets of infant siblings. OBJECTIVE: The goals of this analysis were to examine birth-order differences in dietary intake between firstborn (FB) and secondborn (SB) siblings, and to determine whether a responsive parenting (RP) intervention modified birth-order effects on diet. METHODS: The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study randomly assigned first-time mothers to an RP intervention, which included guidance on feeding, sleep, soothing, and interactive play, or control. INSIGHT mothers who delivered a second child enrolled in an observation-only study of their SB infant (SIBSIGHT). Mothers completed FFQs for both children at ages 6 (n = 97 sibling pairs) and 12 (n = 100) mo. FB compared with SB intake of food groups of interest were compared, and the moderating effect of the RP intervention on birth-order differences was tested using generalized linear mixed models. RESULTS: Though FBs and SBs had similar diets, more FBs than SBs consumed 100% fruit juice at both 6 (13.8 compared with 3.2%, P = 0.006) and 12 mo (46.0 compared with 32.0%, P = 0.01). SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo. There were no differences by birth order in intake of sweets, snacks, or sugar-sweetened beverages at 12 mo. At 12 mo, RP-group SBs ate vegetables more times per day (3.2) than control SBs (2.2, P = 0.01). RP-SBs also consumed a greater variety of vegetables (10.2) than control-SBs (7.9, P = 0.01). CONCLUSIONS: Birth order is not consistently associated with healthy or unhealthy infant dietary intake. However, an RP intervention delivered to first-time mothers may benefit subsequent infants' vegetable intake. This trial was registered at clinicaltrials.gov as NCT01167270.

Correction to: Improving infant sleep safety via electronic health record communication: a randomized controlled trial.

An amendment to this paper has been published and can be accessed via the original article.

Improving infant sleep safety via electronic health record communication: a randomized controlled trial.

BACKGROUND: With increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promote sleep environments consistent with AAP guidelines. METHODS: One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery. We first assessed feasibility as measured by a) the proportion of consented mothers enrolling in the portal and b) maternal adherence to prompts to submit photographs of their infant sleeping to the research team through the patient portal. Intervention group mothers were prompted at 1 and 2 months; controls were prompted only at 2 months. Efficacy was determined via research assistant review of submitted photographs. These assistants were trained to detect sudden unexplained infant death risk factors utilizing AAP guidelines. Standardized feedback was returned to mothers through the patient portal. We used Fisher's Exact test to assess group differences in guideline adherence at 2 months. RESULTS: One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention (N = 55) and control (N = 54) groups. 21 (38, 95% CI 25-52%) intervention group participants sent photographs at 1 month and received personalized feedback. Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75). Common reasons for guideline non-adherence were sleeping in a room without a caregiver (43%), loose bedding (15%) and objects (8%) on the sleep surface. CONCLUSIONS: Utilizing the patient portal to individualize safe infant sleep is possible, however, we encountered numerous barriers in this trial to assess its effects on promoting safe infant sleep. Photographs of infants sleeping showed substantial non-adherence to AAP guidelines, suggesting further needs for improvement to promote safe infant sleep practices. TRIAL REGISTRATION: Name: Improving Infant Sleep Safety With the Electronic Health Record; Clinicaltrials.gov: NCT03662048 ; Date of Registration: September 7, 2018; Data Sharing Statement: None.

Validation and human factor analysis study of an infant weight estimation device.

BACKGROUND: Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). This study was designed to determine the human factors (HF) experience with, and predictive performance of, an infant weight estimation device that implements this method. METHODS: Prospective, multi-center, observational, masked study of 486 preterm and term infants (0-90 days) assessed by 15 raters. Raters measured the infant using calibrated scales/measures and masked versions of the device. Raters also evaluated critical tasks associated with device use. Mean error (ME) and mean percentage error (MPE) were used to assess predictive performance. RESULT: Among 486 infants enrolled (36.8 ± 4.0 weeks gestational age, 31.5 ± 28.6 days postnatal age), predicted weight correlated highly with actual weight (r = 0.97, ME: - 69 ± 257 g, MPE: - 1.3 ± 6.9%). Predicted weight was within 10 and 15% of actual weight in 86 and 99%, of infants. HF errors were low, 0.1-0.8% depending on task. In all cases raters were confident or very confident in their measurements. CONCLUSION: The device was statistically equivalent to the method on which it was based and approximated weight with acceptable variance from the true weight. HF data suggest the device is easy to use. This device can be used to estimate weight in infants when calibrated scales are impractical or unavailable.

Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.

BACKGROUND: Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS: In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS: Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events. CONCLUSIONS: Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).

Ecological momentary assessment of using food to soothe during infancy in the INSIGHT trial.

BACKGROUND: Use of food to soothe infant distress has been linked to greater weight in observational studies. We used ecological momentary assessment to capture detailed patterns of food to soothe and evaluate if a responsive parenting intervention reduced parents' use of food to soothe. METHODS: Primiparous mother-newborn dyads were randomized to a responsive parenting intervention designed for obesity prevention or a safety control group. Responsive parenting curriculum included guidance on using alternative soothing strategies (e.g., swaddling), rather than feeding, as the first response to infant fussiness. After the initial intervention visit 3 weeks after delivery, mothers (n = 157) were surveyed for two 5-8 day bursts at infant ages 3 and 8 weeks. Surveys were sent via text message every 4 h between 10:00 AM-10:00 PM, with 2 surveys sent at 8:00 AM asking about nighttime hours. Infant fusses and feeds were reported for each 4-h interval. Food to soothe was defined as "Fed First" and "Not Fed First" in response to a fussy event. Use of food to soothe was modeled using random-intercept logistic regression. RESULTS: The control group had greater odds of having Fed First, compared to the responsive parenting group at ages 3 and 8 weeks (3 weeks: OR = 1.9; 95% CI = 1.4-2.7; p < 0.01; 8 weeks: OR = 1.4; 95% CI = 1.0-2.1; p = 0.053). More responsive parenting mothers reported using a responsive parenting intervention strategy first, before feeding, than controls at ages 3 and 8 weeks (3 weeks: 58.1% vs. 41.9%; 8 weeks: 57.1% vs. 42.9%, respectively; p < 0.01 for both). At both ages combined, fewer fusses from responsive parenting infants were soothed best by feeding compared to controls (49.5% vs. 61.0%, respectively; p < 0.01). For both study groups combined, parents had greater odds of having Fed First during the nighttime compared to the daytime at both ages (3 weeks: OR = 1.6, 95% CI = 1.4-1.8; p < 0.01; 8 weeks: OR = 2.1; 95% CI = 1.7-2.6; p < 0.01). CONCLUSIONS: INSIGHT's responsive parenting intervention reduced use of food to soothe and increased use of alternative soothing strategies in response to infant fussiness. Education on responsive parenting behaviors around fussing and feeding during early infancy has the potential to improve later self-regulation and weight gain trajectory. TRIAL REGISTRATION: NCT01167270 . Registered July 21, 2010.

Breastfeeding initiation and duration and child health outcomes in the first baby study.

Despite the known benefits of breastmilk, associations between breastfeeding and child overall health outcomes remain unclear. We aimed to understand associations between breastfeeding and health outcomes, including child weight, through age 3. Analysis included women (N = 3006) in the longitudinal, prospective First Baby Study from 2009 to 2014. For this analysis, breastfeeding initiation and duration were measured using self-reported data from the 1-, 6- and 12-month surveys; child illnesses were analyzed from the 6-, 12-, and 24-month interviews; height and weight at age 3 were used to determine overweight/obese (≥85th percentile) and obese (≥95th percentile). Adjusted logistic regressions were utilized to determine significance. Greater duration of breastfeeding was associated with fewer reported acute illnesses at 6 months (p < 0.001) and fewer diarrheal illness/constipation episodes at 6, 12, and 24 months (p = 0.05) in adjusted analyses. Fewer breastfed children, compared to non-breastfed children, were overweight/obese (23.5% vs. 37.8%; p = 0.032) or obese (9.1% vs. 21.6%; p = 0.012) at age 3. Breastfeeding duration was negatively associated with overweight/obese (never breastfed: 37.8%, 0-6 months: 26.9%, >6 months: 20.2%; p = 0.020) and obesity (never breastfed: 21.6%, 0-6 months: 11.0%, >6 months: 7.3%; p = 0.012). Overall, our findings support the hypothesis that duration of breastfeeding is associated with fewer reported acute illnesses at 6 months of age and diarrheal illness and/or constipation episodes at 6, 12, and 24 months. Additionally, results from our study suggest a protective effect of breastfeeding from childhood overweight/obesity, as children who received breastmilk for 6 months or longer had lower odds of overweight/obesity at age 3 years.

Early maternal-newborn contact and positive birth experience.

BACKGROUND: In recent years, there has been increasing recognition of the importance of early maternal-newborn contact for the health and well-being of the newborn and promotion of breastfeeding. However, little research has investigated the association between early maternal-newborn contact and the mother's birth experience. METHODS: As part of a large-scale prospective, cohort study (the First Baby Study [FBS]), nearly 3000 women who delivered in Pennsylvania (2009-2011) reported how soon after delivery they first saw, held, and fed their newborns. Birth experience was measured via telephone interview 1 month postpartum, using the FBS Birth Experience Scale, a 16-item scale which addresses women's feelings about the delivery. General linear models were used to measure associations between time to first maternal-newborn contact and birth experience, controlling for relevant confounders, including maternal age, race/ethnicity, insurance coverage, delivery mode, gestational age, and pregnancy and delivery complications. RESULTS: The sooner that new mothers first saw, held, and fed their newborns after delivery the more positive their childbirth experiences (all P-values < 0.001). Women who delivered by cesarean were less likely to see, hold and feed their newborns shortly after delivery than those who delivered vaginally (all P-values < 0.001), and reported less positive birth experiences (P < 0.001). However, if they first saw, held, and fed their newborns shortly after delivery, they reported more positive birth experiences than those who delivered vaginally (P = 0.010). DISCUSSION: Early maternal-newborn contact after delivery was associated with positive birth experiences for new mothers, particularly those who delivered by cesarean.

Exploring infant signing to enhance responsive parenting: Findings from the INSIGHT study.

Responsive parenting is a promising framework for obesity prevention, yet attempts to date have largely relied on parents accurately interpreting their child's cues. Infant signing or "baby sign language" could enhance these interventions by improving bidirectional parent-child communication during the preverbal and emerging language years. In a clinical trial testing, a responsive parenting intervention designed for obesity prevention, we pilot tested a brief intervention at age 40 weeks with a subset of participating dyads that taught the signing gesture of "all done" to improve parental recognition of satiety. In addition, we surveyed all participating mothers at child age 18 months on the use of infant signing gestures in the prior year. Two hundred twenty-eight mothers completed the survey including 72 responsive parenting group mothers that received the signing instructions. A majority of mothers, 63.6%, reported teaching their infant signs in the prior year, and 61.4% of infants were using signs to communicate at 18 months (median signs = 2). The signs for "more" and "all done" were used by over half of study participants and were the most common signs used. Other signs related to eating or drinking were commonly used. Signing intervention group infants were more likely to use the sign for "all done" than controls (63.9% vs. 45.5%; P = 0.01), but there was no difference between groups with regard to the use of the sign for "more" (56.9% vs. 51.3%; P = 0.43). Signing is commonly used by parents of young children and holds potential to improve parental responsiveness and obesity prevention efforts.

The Effect of Early Limited Formula on Breastfeeding, Readmission, and Intestinal Microbiota: A Randomized Clinical Trial.

OBJECTIVE: To determine whether using 10 mL formula after each breastfeeding before copious maternal milk production affects breastfeeding duration, readmission, and intestinal microbiota through 1 month of age. STUDY DESIGN: In this randomized controlled trial, we enrolled 164 exclusively breastfeeding newborns, 24-72 hours old, whose weight loss was ≥75th percentile for age, and whose mothers had not yet begun mature milk production. Enrolled newborns were assigned randomly to either supplement breastfeeding with early limited formula (ELF), 10 mL of formula after each breastfeeding stopped at the onset of copious maternal milk production (intervention), or to continue exclusive breastfeeding (control). Outcomes assessed through 1 month included breastfeeding duration, readmission, and intestinal microbiota. RESULTS: At 1 week of age, 95.8% of infants receiving ELF and 93.5% of control infants were still breastfeeding (P > .5); readmission occurred for 4 (4.8%) control infants and none of the infants receiving ELF (P = .06). At 1 month of age, 86.5% of infants receiving ELF and 89.7% of control infants were still breastfeeding (P > .5); 54.6% of infants receiving ELF and 65.8% of controls were breastfeeding without formula (P = .18). ELF did not lead to decreased abundance of Lactobacillus or Bifidobacterium and was not associated with expansion of Clostridium. CONCLUSION: In this population of healthy newborns with weight loss ≥75th percentile, ELF did not interfere with breastfeeding at 1 month, breastfeeding without formula at 1 month, or intestinal microbiota. ELF may be an important therapeutic option for newborns with the potential to reduce readmission rates. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02313181.

INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial.

BACKGROUND: What, when, how, how much, and how often infants are fed have been associated with childhood obesity risk. The objective of this secondary analysis was to examine the effect of a responsive parenting (RP) intervention designed for obesity prevention on parents' infant feeding practices in the first year after birth. METHODS: Primiparous mother-newborn dyads were randomized to the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study RP intervention or child safety control. Research nurses delivered intervention content at home at infant age 3-4, 16, 28, and 40 weeks, and at a research center at 1 year. RP feeding guidance advised feeding that was contingent (i.e., feed in response to hunger and satiety signs, alternatives to using food to soothe), and developmentally appropriate (i.e., delaying introduction of solids, age-appropriate portion sizes). Infant feeding practices (i.e., bottle use, introduction of solids, food to soothe) were assessed by phone interviews and online surveys and dietary intake was assessed using a food frequency questionnaire. RESULTS: RP mothers were more likely to use of structure-based feeding practices including limit-setting (p < 0.05) and consistent feeding routines (p < 0.01) at age 1 year. RP group mothers were less likely to use non-responsive feeding practices such as pressuring their infant to finish the bottle/food (p < 0.001), and using food to soothe (p < 0.01), propping the bottle (p < 0.05) assessed between 4 and 8 months, and putting baby to bed with a bottle at age 1 year (p < 0.05). Few differences were seen between groups in what specific foods or food groups infants were fed. CONCLUSIONS: Anticipatory guidance on RP in feeding can prevent the use of food to soothe and promote use of more sensitive, structure-based feeding which could reduce obesity risk by affecting how and when infants are fed during the first year. TRIAL REGISTRATION: The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study. www.clinicaltrials.gov . NCT01167270. Registered 21 July 2010.

INSIGHT responsive parenting intervention reduces infant's screen time and television exposure.

BACKGROUND: Sedentary behaviors, including screen time, in childhood have been associated with an increased risk for overweight. Beginning in infancy, we sought to reduce screen time and television exposure and increase time spent in interactive play as one component of a responsive parenting (RP) intervention designed for obesity prevention. METHODS: The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study is a randomized trial comparing a RP intervention with a safety control intervention. Primiparous mother-newborn dyads (N = 279) were randomized after childbirth. Research nurses delivered intervention content at infant ages 3, 16, 28, and 40 weeks and research center visits at 1 and 2 years. As one component of INSIGHT, developmentally appropriate messages on minimizing screen time, reducing television exposure in the home, and promoting parent-child engagement through interactive play were delivered. Mothers self-reported their infant's screen time at ages 44 weeks, 1, 1.5, 2 and 2.5 years; interactive play was reported at 8 and 20 weeks and 2 years. RESULTS: More RP than control parents reported their infants met the American Academy of Pediatrics' no screen time recommendation at 44 weeks (53.0% vs. 30.2%) and at 1 year on weekdays (42.5% vs. 27.6%) and weekends (45.5% vs. 26.8%), but not after age 1 year. RP mothers and RP children had less daily screen time than controls at each time point (p ≤ 0.01). Fewer RP than control group mothers reported the television was ever on during infant meals (p < 0.05). The frequency of tummy time and floor play did not differ by study group; approximately 95% of infants spent time in restrictive devices (i.e. swing) at 8 and 20 weeks. At 2 years of age, there were no study group differences for time children spent in interactive play. CONCLUSION: From infancy to early childhood, the INSIGHT RP intervention reduced screen time and television exposure, but did not increase the frequency or amount of interactive play. TRIAL REGISTRATION: clinicaltrials.gov NCT01167270 . Registered on 21 July 2010.

Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

BACKGROUND: The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. METHODS: The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). RESULTS: A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. CONCLUSIONS: The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations.

Growth during the first year in infants affected by neonatal abstinence syndrome.

BACKGROUND: Infants with neonatal abstinence syndrome (NAS) initially experience neurologic excitability, poor feeding, and/or hyperphagia in the setting of increased metabolic demand. Because the longitudinal effects of these early symptoms and behaviors on weight trends are unknown, we sought to contrast weight gain patterns through age 1 year for infants diagnosed with NAS with matched controls. METHODS: Retrospective cohort of 70 singletons with a gestational age of ≥37 weeks and an ICD-9 or ICD-10 diagnosis of NAS made ≤7 days after birth with institutional follow-up matched to patients without NAS. Infants were matched on gestational age (±2 weeks), birth weight (±20 g), sex (exact), and insurance type (exact). Quantile regression methods were used to estimate 10th, 25th, 50th, 75th and 90th percentiles of weight over time. RESULTS: The mean gestational age for an infant with NAS was 38.8 weeks (standard deviation [SD], 1.3). The mean birth weight was 3.141 kg (SD, 0.510). NAS patients had a median of 24 weights recorded between birth and 400 days (inter-quartile range [IQR], 16-32 weights). Patients without NAS had a median of 12 weights recorded (IQR, 10-16). Growth curves were similar over the first 400 days of life. Patients with NAS had non-significantly higher and lower estimated weights for the 90th and 10th percentiles, respectively. CONCLUSION: Infants with a diagnosis of NAS grew similarly to controls during their first year. Given the frequently-encountered NAS symptoms of hyperphagia and irritability, future studies may evaluate whether early differences in caregiver feeding exist and whether they have longer-term impacts on growth.

A patient-centered, coordinated care approach delivered by community and pediatric primary care providers to promote responsive parenting: pragmatic randomized clinical trial rationale and protocol.

BACKGROUND: Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months. METHODS/DESIGN: Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the "RP intervention" or "standard care control" groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child's electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes. DISCUSSION: This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs. TRIAL REGISTRATION: Restrospective Clinical Trial Registration: NCT03482908 . Registered March 29, 2018.