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- Title
Two-Year Outcomes of Umbilical Cord Milking in Nonvigorous Infants: A Secondary Analysis of the MINVI Randomized Clinical Trial.
- Authors
Katheria, Anup C.; El Ghormli, Laure; Clark, Erin; Yoder, Bradley; Schmölzer, Georg M.; Law, Brenda H. Y.; El-Naggar, Walid; Rittenberg, David; Sheth, Sheetal; Martin, Courtney; Vora, Farha; Lakshminrusimha, Satyan; Underwood, Mark; Mazela, Jan; Kaempf, Joseph; Tomlinson, Mark; Gollin, Yvonne; Rich, Wade; Morales, Ana; Varner, Michael
- Abstract
Key Points: Question: Among nonvigorous term and near-term newborns, does umbilical cord milking compared with early cord clamping at birth result in improved neurodevelopmental outcomes? Findings: In this secondary analysis to evaluate longer-term outcomes of a randomized clinical trial in 971 infants, the differences in the Ages & Stages Questionnaire total scores between the early cord clamping vs the umbilical cord milking group were not statistically significant. Differences in the medium- to high-risk scores on the Modified Checklist for Autism in Toddlers, Revised/Follow-Up, between the 2 groups were also not statistically significant. Meaning: The findings of this trial suggest that, among nonvigorous term and near-term infants, umbilical cord milking does not result in a statistically significant difference in 2-year neurodevelopmental outcomes compared with early cord clamping. Importance: 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. Objective: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial. Design, Setting, and Participants: 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. Intervention: UCM and ECC. Main Outcomes and Measures: 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. Results: 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). Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT03631940 This secondary analysis of a randomized clinical trial compares neurodevelopmental outcomes after the use of umbilical cord milking or early cord clamping in near-term or term nonvigorous infants at age 2 years.
- Subjects
CANADA; POLAND; UNITED States; RISK assessment; SELF-evaluation; CHILD psychopathology; SECONDARY analysis; RESEARCH funding; PATIENTS; PATIENT safety; INFANT development; QUESTIONNAIRES; NEONATAL intensive care units; HOSPITAL admission &; discharge; NEURAL development; TREATMENT effectiveness; DESCRIPTIVE statistics; MANN Whitney U Test; CHI-squared test; NEONATAL intensive care; DURATION of pregnancy; CHILD development; DATA analysis software; COMPARATIVE studies; CONFIDENCE intervals; UMBILICAL cord clamping; CHILDREN
- Publication
JAMA Network Open, 2024, Vol 7, Issue 7, pe2416870
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.16870