Early human development最新文献

{"title":"Implementation of nutritional care bundle is associated with improved growth in preterm infants born before 32 gestational weeks","authors":"Jiří Dušek ,&nbsp;Elisabeth Stoltz Sjöström ,&nbsp;Itay Nilsson Zamir","doi":"10.1016/j.earlhumdev.2024.106151","DOIUrl":"10.1016/j.earlhumdev.2024.106151","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate whether implementing a nutritional care bundle is associated with growth and morbidity in very preterm (VPT) infants.</div></div><div><h3>Study design</h3><div>This study compared 87 VPT infants (&lt;32 gestational weeks) born 2018 (Before group) with 75 infants born 2020 (After group), treated at a single center in the Czech Republic. A nutritional care bundle was implemented during 2019.</div></div><div><h3>Results</h3><div>Median gestational age (weeks) was 30.0 [IQR 27.6–31.1] for the Before group and 29.9 [IQR 27.9–30.6] for the After group. During postnatal days 1–14, parenteral fluid intake was significantly lower in the After group compared to the Before group and conversely for enteral fluid intake. Infants in the After group achieved full enteral feeds by postnatal day 14 (72.9 % vs. Before group 51.9 %). Weight z-scores decreased significantly less from birth to 36 weeks postmenstrual age in the After group (−0.8 [IQR −1.3 to −0.5]) compared to the Before group (−1.5 [IQR −2.0 to −1.2]). Head circumference z-scores decreased significantly less in the After group (−0.8±0.9) than the Before group (−1.6±1.1). Decreased rate of patent ductus arteriosus (PDA) requiring treatment was observed in the After group (<em>P</em> &lt; 0.001).</div></div><div><h3>Conclusions</h3><div>Implementation of a nutritional care bundle in VPT infants was associated with improved postnatal growth and may reduce treatment-requiring PDA.</div></div>","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"199 ","pages":"Article 106151"},"PeriodicalIF":2.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiac autonomic regulation as a proxy of early neurodevelopment: A systematic review","authors":"Vania Aldrete-Cortez ,&nbsp;Silvia A. Tafoya","doi":"10.1016/j.earlhumdev.2024.106148","DOIUrl":"10.1016/j.earlhumdev.2024.106148","url":null,"abstract":"<div><h3>Background</h3><div>Cardiac autonomic regulation and early neurodevelopment are linked, but research has focused largely on specific domains, such as attention and memory, neglecting broad neurodevelopmental outcomes. The use of diverse study populations and methodologies further hinders interpretation, highlighting the need for more consistent, integrative research in this area. Therefore, the aim of this study was to clarify how cardiac autonomic regulation (as quantified by heart rate indices) is associated with global neurodevelopment in infancy through a systematic literature review.</div></div><div><h3>Method</h3><div>A systematic literature search was carried out in the Scopus, PubMed, Web of Science, and ProQuest databases for studies published between January 1980 and December 2022. The search terms were a combination of words that included elements from three categories: 1) cardiac vagal regulation, 2) neurodevelopment indicators, and 3) population (neonate/infant).</div></div><div><h3>Results</h3><div>Five studies involving 933 infants (48 % of whom were girls) and baseline evaluations from birth to 26 weeks of age were included. The findings were mixed: while some studies identified positive associations between parasympathetic activity and neurodevelopmental outcomes, others reported nonsignificant or inconsistent associations. The variability in study designs, measurement methods, and population characteristics likely contributed to these discrepancies. However, respiratory sinus arrhythmia (RSA) was the most commonly used indicator, and the highest percentage of studies reported significant associations between neurodevelopment and autonomous functioning (RSA = 83 %, heart rate variability = 69 %), particularly when controlling for factors such as age and birthweight.</div></div><div><h3>Conclusions</h3><div>Although autonomic regulation during the first years of life appears to be associated with neurodevelopment, the evidence is not entirely consistent across all heart rate indices or developmental domains. Further research is needed to better understand these relationships, particularly in light of the methodological differences and potential confounding factors. Recognizing individual differences in autonomic nervous system regulation could provide valuable insights into neurodevelopmental trajectories.</div></div>","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"199 ","pages":"Article 106148"},"PeriodicalIF":2.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validity and use of the Neonatal Infant Stressor Scale: An integrative review","authors":"Marliese Dion Nist ,&nbsp;Ashley Ford ,&nbsp;Claire Packer ,&nbsp;Thao Griffith","doi":"10.1016/j.earlhumdev.2024.106146","DOIUrl":"10.1016/j.earlhumdev.2024.106146","url":null,"abstract":"<div><h3>Background</h3><div>Stress exposure, operationalized as a count of painful or skin-breaking breaking procedures, is an important concept for inclusion in studies of preterm infants. The Neonatal Infant Stressor Scale (NISS) was developed to also account for nonpainful and environmental stressors; however, validity of this measure is unknown.</div></div><div><h3>Aims</h3><div>The purpose of this review was to define the breadth of use of the NISS in neonatal research studies and determine its predictive and concurrent validity.</div></div><div><h3>Methods</h3><div>Using the methods for integrative review, a systematic search of the literature was conducted using PubMed, CINAHL, PsycINFO, and Embase with keywords “NISS” OR “Neonatal Infant Stressor Scale”. Study findings were narratively synthesized.</div></div><div><h3>Results</h3><div>Twenty-nine articles were retained for the review and included two cross-sectional studies describing development or adaptation of the measure, two protocols for empirical studies, and 25 empirical studies of preterm infants. Modifications to the original NISS were common and included addition or exclusion of specific stressors and use of unweighted scores. Although findings were inconsistent across studies, limited data support the predictive validity of the NISS, as higher NISS scores have been associated with abnormal brain development and cognitive, motor, and behavioral deficits. Two studies found concurrent associations between NISS scores and cortisol.</div></div><div><h3>Conclusion</h3><div>The NISS may be a useful tool to quantify stressors experienced by preterm infants; however, there are only limited data to support its predictive or concurrent validity. The NISS may be particularly useful as a method to bring awareness to the infant's stress burden in clinical practice. Additional research is needed to validate inclusion of specific stressors in the NISS.</div></div>","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"199 ","pages":"Article 106146"},"PeriodicalIF":2.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 pandemic and the neurodevelopment of Brazilian infants: Analysis of predictors according to the Nurturing Care Framework","authors":"Isadora A. Martins ,&nbsp;Vivian M.G.O. Azevedo ,&nbsp;Gabriela S.M.A. Pinheiro ,&nbsp;Luiza A. Ford ,&nbsp;Renata M.P. Silva ,&nbsp;Leticia U. Rodrigues ,&nbsp;Janaína M. Moreira ,&nbsp;Stela M.A. Lemos ,&nbsp;Claudia R.L. Alves","doi":"10.1016/j.earlhumdev.2024.106145","DOIUrl":"10.1016/j.earlhumdev.2024.106145","url":null,"abstract":"<div><h3>Introduction</h3><div>Concerns have been raised about the potential negative impacts of the COVID-19 pandemic on child development; this issue can be analyzed using the Nurturing Care Framework (NCF).</div></div><div><h3>Objective</h3><div>To analyze the predictors of neurodevelopment at 12 months in infants born during the pandemic in Brazil, according to the NCF.</div></div><div><h3>Methods</h3><div>It is a longitudinal case-control study involving 284 infants born between April and August 2021. Mothers were interviewed at birth and at six months postpartum. At 12 months, the infants' neurodevelopment was assessed using the Bayley III Scale. The explanatory variables were grouped according to NCF components, and their association with Bayley III results was examined using hierarchical logistic regression, adjusting for socioeconomic status and gestational exposure to SARS-CoV-2.</div></div><div><h3>Results</h3><div>Twenty percent of the sample exhibited delays in at least one Bayley III domain (3% cognitive, 16 % language, and 7 % motor). We found an increased risk of cognitive (OR = 5.78; 95 % CI 1.07–31.09) and motor delays (OR = 6.97; 95 % CI 2.17–22.38) for children who had not undergone regular well-child care in their first six months. The likelihood of a child showing some delay at 12 months was 2.23 times higher when the mother reported concerns about the child's development at six months (95 % CI 1.11–4.50).</div></div><div><h3>Conclusion</h3><div>Well-child care emerged as a protective factor against cognitive and motor delays, while the mother's concerns were predictive of future developmental issues.</div></div>","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"200 ","pages":"Article 106145"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of neonates exposed prenatally to opioids: Impact of a developmental care program implementation","authors":"Gilles Cambonie ,&nbsp;Lison Aujogues dit Baron ,&nbsp;Clementine Combes ,&nbsp;Corinne Chanal ,&nbsp;Evelyne Mazurier ,&nbsp;Rose-Marie Toubin ,&nbsp;Mathilde Fortier ,&nbsp;Angelo Polito ,&nbsp;Florent Fuchs ,&nbsp;Arthur Gavotto","doi":"10.1016/j.earlhumdev.2024.106132","DOIUrl":"10.1016/j.earlhumdev.2024.106132","url":null,"abstract":"<div><h3>Background</h3><div>Traditional approaches to management of neonates prenatally exposed to opioids are based on the use of pharmacotherapy (PT), adjusted to evolution of infant symptoms. Newer approaches focused on non-pharmacological care (NPC) are emerging, but there is little evidence on the active policies to implement to ensure their widespread practice. The primary objective of the study was to assess whether the implementation of a developmental care program in our neonatal medicine department had an impact on the management of these infants during hospitalization, notably exposure to NPC.</div></div><div><h3>Method</h3><div>Observational study in a tertiary perinatal center. Data collected during hospitalization for infants with in utero opioid exposure included admission in the parents-infant unit (PIU) of the maternity ward, exposure to NPC and PT, occurrence of neonatal opioid withdrawal syndrome (NOWS), length of hospital stay (LOS) and feeding type at discharge. The impact of the intervention was measured by comparing three 6-year periods, the first preceding the implementation of a formalized developmental care program (2003–2008); the second following implementation of the program (2009–2014); the third after consolidation of the program (2015–2020).</div></div><div><h3>Results</h3><div>258 infants prenatally exposed to opioid were recorded. From the first to the third period, admission rate in the PIU was comparable (68 % to 73 %, <em>p</em> = 0. 95). Exposure to NPC (37 % to 84 %, <em>p</em> &lt; 0.001) increased, whereas exposure to PT (40 % to 15 %, <em>p</em> = 0.002) and LOS (13 [9–18] days to 8 [6–11] days, <em>p</em> = 0.003) decreased. NOWS occurred in 141 (55 %) infants (63 % to 47 %, <em>p</em> = 0.10). In these infants, decrease in PT was also observed (64 % to 34 %, <em>p</em> = 0.02). After adjustment for perinatal confounders, hospitalization in the PIU (OR 3.23 [1.36; 7.66]; <em>p</em> = 0.008), and the 2015–2020 period (OR 5.11 [2.06; 12.64]; <em>p</em> = 0.004) were associated with absence of PT.</div></div><div><h3>Conclusions</h3><div>An active policy, supporting the training and warranting the practice of NPC, is essential to reduce medication usage and length of hospitalization in infants exposed in utero to opioids.</div></div>","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"198 ","pages":"Article 106132"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diet, growth, nutritional status and predictors of severity of feeding difficulties in autistic children with co-occurring pediatric feeding disorder","authors":"Tammy S.H. Lim ,&nbsp;Chui Ying Wong ,&nbsp;Charlotte Lin ,&nbsp;Quan Quan Phua ,&nbsp;Ada E.S. Tok ,&nbsp;Alison S.M. Cheng ,&nbsp;Yiong Huak Chan ,&nbsp;Marion M. Aw","doi":"10.1016/j.earlhumdev.2024.106137","DOIUrl":"10.1016/j.earlhumdev.2024.106137","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Feeding difficulties are commonly reported in autistic children. However, there is limited data on the presentation, severity, and impact of feeding difficulties in autistic children in Asia.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Aims&lt;/h3&gt;&lt;div&gt;To describe the dietary patterns, growth and nutritional status of autistic children with pediatric feeding disorder (PFD), and identify factors associated with more severe feeding difficulties.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Study design&lt;/h3&gt;&lt;div&gt;A retrospective review of electronic medical records.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Subjects&lt;/h3&gt;&lt;div&gt;Autistic children (aged between 0 and 18 years) with PFD, who attended a multidisciplinary feeding clinic between August 2013 and December 2022.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Outcome measures&lt;/h3&gt;&lt;div&gt;The children's parents provided a 3-day food diary, which was verified by the dietitian and analyzed for their nutritional content using Foodworks 10 Professional. Food selectivity was classified as mild, moderate or severe, based on the number of food groups accepted and the absolute number of foods accepted in each group. Information regarding demographics, height, weight, medical information, developmental history (autism diagnosis, cognition, adaptive skills) and relevant nutritional bloodwork were collected. Parents also completed two validated questionnaires (the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), which assessed childhood mealtime behaviors; and the Caregiver Feeding Style Questionnaire (CFSQ), which determined caregiver/ parental feeding styles). Factors associated with higher BPFAS total frequency scores (TFS) (representing more severe feeding difficulties) and food selectivity were analyzed.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;There were a total of 98 patients (82 males), with mean ± SD (range) age of 59.2 ± 27.5 (17–169) months. They had mild (19.4 %), moderate (22.4 %) and severe (58.2 %) food selectivity, respectively. While the majority had normal weight (84.7 %) and height (88.8 %) for age, 69.4 % had diets deficient in calories, macronutrients or micronutrients (iron, calcium). Comparison between groups according to parental feeding style found that there was a significant difference in BFPAS TFS between different parental feeding styles (&lt;em&gt;p&lt;/em&gt; &lt; 0.001). Post-hoc testing revealed that parents who reported an authoritarian parental feeding style on the CFSQ were significantly more likely to report higher frequencies of difficult feeding behaviors on the BPFAS (98.3 ± 15.8), while an uninvolved parental feeding style was associated with the lowest BPFAS TFS (80.9 ± 11.0), Bonferroni-adjusted &lt;em&gt;p&lt;/em&gt; &lt; 0.001; indulgent (&lt;em&gt;p&lt;/em&gt; = 0.012) and authoritative (&lt;em&gt;p&lt;/em&gt; = 0.096). Intellectual impairment and Malay ethnicity were associated with more severe food selectivity [adjusted odds ratio 123.7 (95 % CI 3.09–4945.4, &lt;em&gt;p&lt;/em&gt; = 0.01) and 38.0 (95 % CI 1.35–1074.18, &lt;em&gt;p&lt;/em&gt; = 0.03)], respectively.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"199 ","pages":"Article 106137"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Special Issue “Biological and Psychological Perspectives”: Guest editorial","authors":"Bernhard Fink ,&nbsp;John T. Manning","doi":"10.1016/j.earlhumdev.2024.106127","DOIUrl":"10.1016/j.earlhumdev.2024.106127","url":null,"abstract":"","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"198 ","pages":"Article 106127"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations between maternal depression trajectories and infant neurodevelopment at eight months","authors":"Xiuxiu Li ,&nbsp;Xuemei Liu ,&nbsp;Min Wei ,&nbsp;Xuhua Liu ,&nbsp;Xiaojun Shi ,&nbsp;Yanna Zhu ,&nbsp;Rui Ma ,&nbsp;Rui Gao","doi":"10.1016/j.earlhumdev.2024.106138","DOIUrl":"10.1016/j.earlhumdev.2024.106138","url":null,"abstract":"<div><h3>Background</h3><div>Maternal depression is an increasingly recognized risk factor of child neurodevelopment difficulties. Few studies have investigated the association between the severity and duration of maternal depression and child development. We aimed to identify whether trajectories of maternal depressive symptoms from pregnancy to six months postpartum are associated with child development at eight months.</div></div><div><h3>Methods</h3><div>We included 988 mother-child pairs who participated in Shenzhen Birth Cohort Study, which was conducted in Shenzhen Nanshan Maternity &amp; Child Healthcare Hospital of China. Maternal depressive symptoms were evaluated by the Edinburgh Postnatal Depression Scale (EPDS) at late pregnancy, 1, 3 and 6 months postpartum. Child emotional and behavioral development were assessed by Ages and Stages Questionnaires: Social-Emotional (ASQ-se) and Ages and Stages Questionnaires-Third Edition (ASQ-3) at aged 8 months. Latent profile analysis (LPA) was used to identify the trajectories of maternal depressive symptoms. Univariate and multivariate linear regression were conducted to explore the association between the depressive symptoms trajectories and child development.</div></div><div><h3>Results</h3><div>Four trajectories of maternal depressive symptoms were identified by LPA: low (<em>n</em> = 597), subclinical (<em>n</em> = 91), moderately low and increasing (<em>n</em> = 246) and persistently high (54). Multivariable regression model showed that children of mothers with persistently high depressive symptoms were more likely to have lower scores in three ASQ-3 domains: fine motor (beta [95%C]): −2.30 [−4.32, −0.29], problem-solving (−3.72 [−5.81, −1.62]) and personal-social motor (−2.56 [−4.98, −0.15]), but higher ASQ-se scores (9.49 [5.09, 13.9]). Compared to children of mothers with low depressive symptoms, subclinical depressive symptoms were prediposed to having lower scores in two ASQ-3 domains: communication motor (−2.48 [−4.32, −0.64]) and gross motor (−2.35 [−4.2,-0.51]) and lower ASQ-se scores(4.86 [2.54, 7.18]).</div></div><div><h3>Conclusion</h3><div>Higher levels of maternal depression symptoms were associated with increased risk of child developmental delay, highlighting the importance of early intervention and addressing maternal depression from pregnancy through early childhood.</div></div>","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"199 ","pages":"Article 106138"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ontogeny for a lifetime – Structure meets function","authors":"Peter B. Marschik ,&nbsp;Arend F. Bos ,&nbsp;Dajie Zhang ,&nbsp;Fabrizio Ferrari ,&nbsp;Giovanni Cioni ,&nbsp;GM-Trust and GM-Trust-Tutors","doi":"10.1016/j.earlhumdev.2024.106135","DOIUrl":"10.1016/j.earlhumdev.2024.106135","url":null,"abstract":"","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"199 ","pages":"Article 106135"},"PeriodicalIF":2.2,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advocating for drug development in newborn infants","authors":"Karel Allegaert ,&nbsp;Souvik Mitra ,&nbsp;Anne Smits ,&nbsp;Mark A. Turner","doi":"10.1016/j.earlhumdev.2024.106136","DOIUrl":"10.1016/j.earlhumdev.2024.106136","url":null,"abstract":"<div><div>Neonatal care needs more robust guidance on pharmacotherapy, (formulation, dosage regimen, safety and efficacy information). This requires structured advocacy. We therefore discuss advocacy related to improving information about medicines including current practices, clinical trials, the current setting, and trial preparedness. This steps can improve neonatal drug development by generating evidence, particularly if a programmatic approach (identify dosing, eligibility criteria, and outcomes) to evidence generation is followed.</div><div>Trial design should be guided by the intended use of the medicine and the benefits/risks that the study participant is exposed to. Regulatory trials (explanatory, controlled environment, internal validity, endpoints reflect clinically important outcomes, strong causal evidence) are sometimes necessary. However, some research questions are best addressed with informative trials. In either case, trial design can be supported by real world data and evidence, extrapolation from other subpopulations, or physiologically-based pharmacokinetic modeling. Data management, safety reporting, and management of drugs should be specified and proportionate.</div><div>Trial design and conduct also necessitate awareness of Good Clinical Practice specific to neonates. Relevant aspects include protocol and trial design, research skills and interactions with Ethics Committees or Institutional Research Boards, capacities and competences needed within the research team, and aspects related to consent and recruitment.</div></div>","PeriodicalId":11435,"journal":{"name":"Early human development","volume":"199 ","pages":"Article 106136"},"PeriodicalIF":2.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142563968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}