دورية أكاديمية
Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids: The ALPS Follow-Up Study.
| العنوان: | Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids: The ALPS Follow-Up Study. |
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| المؤلفون: | Gyamfi-Bannerman C; Columbia University, New York, New York.; University of California, San Diego, La Jolla., Clifton RG; George Washington University Biostatistics Center, Washington, DC., Tita ATN; University of Alabama at Birmingham., Blackwell SC; University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston., Longo M; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland., de Voest JA; George Washington University Biostatistics Center, Washington, DC., O'Shea TM; University of North Carolina at Chapel Hill, Chapel Hill., Bousleiman SZ; Columbia University, New York, New York., Ortiz F; University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston., Rouse DJ; Brown University, Providence, Rhode Island., Metz TD; University of Utah Health Sciences Center, Salt Lake City., Saade GR; University of Texas Medical Branch, Galveston.; Eastern Virginia Medical School, Norfolk., Rood KM; Ohio State University, Columbus., Heyborne KD; University of Colorado School of Medicine, Anschutz Medical Campus, Aurora., Thorp JM Jr; University of North Carolina at Chapel Hill, Chapel Hill., Swamy GK; Duke University, Durham, North Carolina., Grobman WA; Northwestern University, Chicago, Illinois., Gibson KS; MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio., El-Sayed YY; Stanford University, Stanford, California., Macones GA; University of Texas at Austin. |
| مؤلفون مشاركون: | Eunice Kennedy Shriver Maternal-Fetal Medicine Units Network |
| المصدر: | JAMA [JAMA] 2024 May 21; Vol. 331 (19), pp. 1629-1637. |
| نوع المنشور: | Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Betamethasone*/administration & dosage , Betamethasone*/adverse effects , Betamethasone*/therapeutic use , Glucocorticoids*/administration & dosage , Glucocorticoids*/adverse effects , Glucocorticoids*/therapeutic use , Neurodevelopmental Disorders*/chemically induced , Neurodevelopmental Disorders*/epidemiology , Prenatal Exposure Delayed Effects*/chemically induced, Child ; Female ; Humans ; Infant, Newborn ; Male ; Pregnancy ; Child Development/drug effects ; Follow-Up Studies ; Infant, Premature ; Premature Birth/prevention & control ; Prenatal Care ; Prospective Studies |
| مستخلص: | Importance: The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids. Objective: To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes. Design, Setting, and Participants: Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022. Exposure: Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart. Main Outcome and Measures: The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up. Results: Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups. Conclusion and Relevance: In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older. |
| التعليقات: | Comment in: JAMA. 2024 May 21;331(19):1626-1627. (PMID: 38656755) |
| معلومات مُعتمدة: | UG1 HD040485 United States HD NICHD NIH HHS; U24 HD036801 United States HD NICHD NIH HHS; UG1 HD027869 United States HD NICHD NIH HHS; UG1 HD040545 United States HD NICHD NIH HHS; UG1 HD040500 United States HD NICHD NIH HHS; UG1 HD034208 United States HD NICHD NIH HHS; UG1 HD053097 United States HD NICHD NIH HHS; UG1 HD027915 United States HD NICHD NIH HHS; UG1 HD068282 United States HD NICHD NIH HHS; U10 HD040560 United States HD NICHD NIH HHS; UG1 HD068258 United States HD NICHD NIH HHS; UG1 HD040512 United States HD NICHD NIH HHS; UG1 HD040544 United States HD NICHD NIH HHS; UG1 HD068268 United States HD NICHD NIH HHS; R01 HL098354 United States HL NHLBI NIH HHS |
| المشرفين على المادة: | 9842X06Q6M (Betamethasone) 0 (Glucocorticoids) |
| تواريخ الأحداث: | Date Created: 20240424 Date Completed: 20240521 Latest Revision: 20240603 |
| رمز التحديث: | 20240603 |
| مُعرف محوري في PubMed: | PMC11044009 |
| DOI: | 10.1001/jama.2024.4303 |
| PMID: | 38656759 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2024.4303 |