Abstract：
UNASSIGNED: Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known.
UNASSIGNED: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial.
UNASSIGNED: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks\' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years.
UNASSIGNED: UCM and ECC.
UNASSIGNED: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used.
UNASSIGNED: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86).
UNASSIGNED: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03631940.
UNASSIGNED: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial.
UNASSIGNED: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks\' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years.
UNASSIGNED: UCM and ECC.
UNASSIGNED: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used.
UNASSIGNED: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86).
UNASSIGNED: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03631940.
摘要：
■与早期夹线（ECC）相比，脐带挤奶（UCM）减少分娩室心肺支持，缺氧缺血性脑病,和治疗性低温在无活力的近月和足月婴儿。然而,UCM出院后结果未知。
■在无活力婴儿挤奶（MINVI）试验中，确定出生时随机接受UCM或ECC治疗的儿童的2年结局。
■从2021年1月9日至2023年9月25日进行了二次分析，以评估集群随机交叉试验的长期结果。初步试验在美国的10个医疗中心进行，加拿大,和波兰从2019年1月5日至2021年6月1日，并假设与ECC相比，UCM将减少新生儿重症监护病房的入院；随访于2023年9月26日结束。该人群包括出生时年龄在35至42周的近月和足月婴儿，他们没有活力；家庭同意完成2岁以下的发育筛查问卷。
■UCM和ECC。
■年龄和阶段问卷，第三版（ASQ-3）和改良的幼儿自闭症清单，修订/随访（M-CHAT-R/F）调查问卷，年龄在22至26个月。使用意向治疗分析和符合方案分析。
■在初审的1730名新生儿中，在2岁时可获得ASQ-3评分或2岁前死亡的971名儿童(81%)和M-CHAT-R/F评分或2岁前死亡的927名儿童(77%)中,我们评估了长期结局.治疗组产妇和新生儿特征相似，中位出生胎龄为39岁(IQR，两组均为38-40周；UCM组中有224名婴儿（45％），ECC组中有201名婴儿（43％）为女性。ASQ-3总分中位数相似(UCM：255[IQR，225-280]vsECC：255[IQR，230-280]；P=.87），在ASQ-3子域中没有显着差异。中高风险M-CHAT-R/F评分也相似(UCM，9%[486人中的45人]与ECC，8%[441个中的37个]；P=0.86）。
■在这项对出生时活力不足的近期晚期和足月婴儿的随机临床试验的二次分析中，2岁时的ASQ-3评分在UCM组和ECC组之间没有显着差异。结合先前报告的重要短期利益，这项后续研究表明UCM是可行的，无成本干预没有长期神经发育风险的非剧烈近期和足月新生儿脐带挤奶。
■ClinicalTrials.gov标识符：NCT03631940。
■在无活力婴儿挤奶（MINVI）试验中，确定出生时随机接受UCM或ECC治疗的儿童的2年结局。
■从2021年1月9日至2023年9月25日进行了二次分析，以评估集群随机交叉试验的长期结果。初步试验在美国的10个医疗中心进行，加拿大,和波兰从2019年1月5日至2021年6月1日，并假设与ECC相比，UCM将减少新生儿重症监护病房的入院；随访于2023年9月26日结束。该人群包括出生时年龄在35至42周的近月和足月婴儿，他们没有活力；家庭同意完成2岁以下的发育筛查问卷。
■UCM和ECC。
■年龄和阶段问卷，第三版（ASQ-3）和改良的幼儿自闭症清单，修订/随访（M-CHAT-R/F）调查问卷，年龄在22至26个月。使用意向治疗分析和符合方案分析。
■在初审的1730名新生儿中，在2岁时可获得ASQ-3评分或2岁前死亡的971名儿童(81%)和M-CHAT-R/F评分或2岁前死亡的927名儿童(77%)中,我们评估了长期结局.治疗组产妇和新生儿特征相似，中位出生胎龄为39岁(IQR，两组均为38-40周；UCM组中有224名婴儿（45％），ECC组中有201名婴儿（43％）为女性。ASQ-3总分中位数相似(UCM：255[IQR，225-280]vsECC：255[IQR，230-280]；P=.87），在ASQ-3子域中没有显着差异。中高风险M-CHAT-R/F评分也相似(UCM，9%[486人中的45人]与ECC，8%[441个中的37个]；P=0.86）。
■在这项对出生时活力不足的近期晚期和足月婴儿的随机临床试验的二次分析中，2岁时的ASQ-3评分在UCM组和ECC组之间没有显着差异。结合先前报告的重要短期利益，这项后续研究表明UCM是可行的，无成本干预没有长期神经发育风险的非剧烈近期和足月新生儿脐带挤奶。
■ClinicalTrials.gov标识符：NCT03631940。
