Premature Infants Receiving Cord Milking Or Delayed Cord Clamping
接受脐带挤奶或延迟断脐的早产儿
基本信息
- 批准号:9914830
- 负责人:
- 金额:$ 57.25万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-04-01 至 2022-03-31
- 项目状态:已结题
- 来源:
- 关键词:AgeAmerican College of Obstetricians and GynecologistsAreaAutologous Blood TransfusionBilirubinBirthBloodBlood TransfusionBlood VolumeBlood flowBrainBudgetsCardiacCesarean sectionCessation of lifeClosure by clampCritical IllnessDataGuidelinesHemorrhageHospitalizationHourHumanHypotensionIncidenceInfantInternationalInterventionLifeMeta-AnalysisMethodsMilkMorbidity - disease rateNeonatalNeurodevelopmental ImpairmentNewborn InfantOperative Surgical ProceduresOrganOutcomePerfusionPhasePhysiologicalPlacentaPolycythemiaPremature InfantPreterm brain injuryPublic HealthRandomizedReportingResearchResuscitationRiskSafetySample SizeSamplingSolidTechniquesTestingTimeTransfusionTranslatingUmbilical cord structureVaginal delivery procedureblood perfusioncerebral hemodynamicscerebral oxygenationcostdesignexpectationfollow-upgraspimprovedintraventricular hemorrhageneonatal outcomeoptimal treatmentspilot trialpreterm newbornside effecttrial comparingtrial design
项目摘要
BACKGROUND: Preterm brain injury from intraventricular hemorrhage (IVH) is a pressing worldwide public
health problem. Over 12,000 premature newborns develop IVH every year in the US alone. Delaying clamping
the umbilical cord at birth for 30-60 seconds provides the newborn with a significant autologous transfusion of
blood from the placenta and has been shown to reduce IVH. Delayed cord clamping (DCC) has been shown
to reduce overall IVH (mainly lower grades 1 and 2) by 50 percent, but has not reduced the incidence of severe
IVH or death. This may reflect inadequate placental transfusion for newborns delivered by Cesarean section
(C/S), the most common mode of delivery for very preterm infants. In 3 DCC trials an increased placental
transfusion was evident in infants born by vaginal delivery (V/D), but no or minimal transfusion in infants delivered
by C/S. We evaluated a technique – umbilical cord milking (UCM) – which provides a placental transfusion by
grasping the unclamped umbilical cord and pushing blood towards the newborn several times before the cord is
clamped. Our Phase 1 pilot trial (PREMOD) compared UCM to DCC in premature newborns delivered by C/S
and V/D. Results were equivalent for V/D. UCM improved blood flow and organ perfusion in C/S infants.
SPECIFIC AIMS: The specific aims of this trial are:
Aim 1. To compare the incidence of severe IVH and/or death in premature newborns <32 weeks GA delivered
by C/S receiving UCM to those receiving DCC.
Aim 2. To compare the safety and efficacy profiles of premature newborns <32 weeks GA delivered by C/S
receiving UCM vs. DCC during their hospitalization and at 24 months corrected age.
Aim 3. To compare the outcomes of premature newborns <32 weeks GA delivered by C/S (from Aims 1 and 2)
with those born by V/D receiving UCM or DCC.
DESIGN: This trial has a 2-tiered approach that will first demonstrate that the incidence of severe IVH and/or
death in premature newborns <32 weeks delivered by C/S with UCM is equivalent to DCC (non-inferiority), and
then test whether there is a decreased incidence of severe IVH and/or death with UCM (superiority). This
approach is being used in other neonatal trials, is endorsed by the FDA, and can be done within the scope and
sample of the proposed trial. DCC: The obstetrician will wait at least 60 seconds to clamp the cord. UCM: The
obstetrician will milk about 20 cm of umbilical cord four times over 2 seconds each. Brain oxygenation will be
recorded for the first 72 hours of life. Outcomes will include resuscitation interventions and neurodevelopmental
follow-up at 2 years. UCM is simple and allows resuscitation of the most critical infants without delay, which
justifies its use, even if UCM is equivalent to DCC. Optimal umbilical cord management in premature newborns
is an area that urgently needs scientific evidence to establish clear guidelines worldwide.
背景:脑室内出血(IVH)引起的早产儿脑损伤是一个紧迫的世界性问题
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('Anup C Katheria', 18)}}的其他基金
Sharp Neonatal Research Institute Clinical Center (Sharp NRI-CC)
夏普新生儿研究所临床中心 (Sharp NRI-CC)
- 批准号:
10683030 - 财政年份:2023
- 资助金额:
$ 57.25万 - 项目类别:
Delayed Cord Clamping with Oxygen In Extremely Low Gestational Age Infants (DOXIE)
极低胎龄婴儿延迟供氧断脐 (DOXIE)
- 批准号:
10549378 - 财政年份:2022
- 资助金额:
$ 57.25万 - 项目类别:
Delayed Cord Clamping with Oxygen In Extremely Low Gestational Age Infants (DOXIE)
极低胎龄婴儿延迟供氧断脐 (DOXIE)
- 批准号:
10373881 - 财政年份:2022
- 资助金额:
$ 57.25万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10213792 - 财政年份:2019
- 资助金额:
$ 57.25万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10677891 - 财政年份:2019
- 资助金额:
$ 57.25万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10457371 - 财政年份:2019
- 资助金额:
$ 57.25万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10018511 - 财政年份:2019
- 资助金额:
$ 57.25万 - 项目类别:
Umbilical Cord Milking in Non Vigorous Infants (the MINVI Trial)
非活力婴儿的脐带挤奶(MINVI 试验)
- 批准号:
10401868 - 财政年份:2018
- 资助金额:
$ 57.25万 - 项目类别:
Umbilical Cord Milking in Non Vigorous Infants (the MINVI Trial)
非活力婴儿的脐带挤奶(MINVI 试验)
- 批准号:
10188576 - 财政年份:2018
- 资助金额:
$ 57.25万 - 项目类别:
Premature Infants Receiving Cord Milking Or Delayed Cord Clamping
接受脐带挤奶或延迟断脐的早产儿
- 批准号:
9452999 - 财政年份:2017
- 资助金额:
$ 57.25万 - 项目类别:
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