Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Katheria AC
PROVIDER: S-EPMC9877105 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Publications
Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial.
Katheria Anup C AC Clark Erin E Yoder Bradley B Schmölzer Georg M GM Yan Law Brenda Hiu BH El-Naggar Walid W Rittenberg David D Sheth Sheetal S Mohamed Mohamed A MA Martin Courtney C Vora Farha F Lakshminrusimha Satyan S Underwood Mark M Mazela Jan J Kaempf Joseph J Tomlinson Mark M Gollin Yvonne Y Fulford Kevin K Goff Yvonne Y Wozniak Paul P Baker Katherine K Rich Wade W Morales Ana A Varner Michael M Poeltler Debra D Vaucher Yvonne Y Mercer Judith J Finer Neil N El Ghormli Laure L Rice Madeline Murguia MM
American journal of obstetrics and gynecology 20220813 2
<h4>Background</h4>Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits.<h4>Objective</h4>We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit c ...[more]
Similar Datasets
Project description:ObjectiveA large, randomized cluster cross-over trial (N = 1730) comparing intact umbilical cord milking (UCM) to early cord clamping (ECC) in non-vigorous near-term/term newborns demonstrated a reduction in cardiorespiratory interventions at birth and less moderate to severe hypoxic ischemic encephalopathy. We evaluated changes in cerebral tissue oxygenation (StO2), pulse oximetry (SpO2), pulse rate and fraction of inspired oxygen (FiO2) during the first 10 min of life in a subset of infants enrolled in the parent trial.Study designInfants enrolled in the Milking in Non-Vigorous Infants trial that had StO2 monitoring at birth were included in the sub-study conducted at 3 hospitals the US and Canada. A near-infrared spectroscopy sensor, pulse oximeter and electrocardiogram electrodes were placed. Pulse rate, StO2, SpO2, and FiO2 were collected for the first 10 min after birth. Longitudinal models were used to compare effects of UCM and ECC.ResultsThirty-four infants had StO2 data. Fifteen of these infants received UCM and 19 had ECC. Infants receiving UCM had similar heart rates, SpO2, and StO2 values, but were exposed to less FiO2 over the first 10 min of life than infants with ECC (0.26 ± 0.12 vs. 0.81 ± 0.05 at 10 min).ConclusionNon-vigorous term/near term infants who received UCM at birth required lower FiO2 after delivery when compared to infants who umbilical cords were clamped soon after birth while achieving similar peripheral and cerebral oxygenation. Cord milking may be a potential option for placental transfusion in non-vigorous near term/term infants when delayed cord clamping cannot be performed.
| S-EPMC10034920 | biostudies-literature
Project description:Delayed cord clamping has been shown to decrease the need for transfusion in preterm neonates, but may delay resuscitation. The aim of this study was to determine whether umbilical cord milking compared with immediate cord clamping in extremely preterm deliveries reduces the need for neonatal red blood cell transfusion.Women admitted to a tertiary care center and expected to deliver between 24 to 28 completed weeks of gestation were randomized to cord milking before clamping or immediate cord clamping. The primary outcome was the risk of neonatal transfusion, reported as risk ratio (RR) and 95% confidence interval (CI).Of 113 women who were enrolled and randomized, 56 were assigned to cord milking with 36 remaining eligible and completing the study and 57 were assigned to the control group with 39 remaining eligible and completing the study. Albeit not statistically significant, neonates in the cord milking group were less likely to require transfusion compared with those in the control group (RR: 0.86; 95% CI: 0.73 to 1.0). Neonates whose cords were milked had higher hematocrits at birth (P=0.004) and were less likely to develop an intraventricular hemorrhage (P=0.0195).Milking the umbilical cord of a preterm neonate is an easy intervention with the potential to improve perinatal outcomes. Our results suggest that milking of the cord increases the neonate's initial hematocrit and may lessen the need for transfusion in the neonatal period. The observed reduction in the incidence of intraventricular hemorrhage may have important long-term implications that warrant further study.
| S-EPMC3916936 | biostudies-literature
Project description:Background and objectiveDelayed cord clamping (DCC) is recommended for premature infants to improve blood volume. Most preterm infants are born by cesarean delivery (CD), and placental transfusion may be less effective than in vaginal delivery (VD). We sought to determine whether infants <32 weeks born by CD who undergo umbilical cord milking (UCM) have higher measures of systemic blood flow than infants who undergo DCC.MethodsThis was a 2-center trial. Infants delivered by CD were randomly assigned to undergo UCM or DCC. Infants delivered by VD were also randomly assigned separately. UCM (4 strippings) or DCC (45-60 seconds) were performed. Continuous hemodynamic measurements and echocardiography were done at site 1.ResultsA total of 197 infants were enrolled (mean gestational age 28 ± 2 weeks). Of the 154 infants delivered by CD, 75 were assigned to UCM and 79 to DCC. Of the infants delivered by CD, neonates randomly assigned to UCM had higher superior vena cava flow and right ventricular output in the first 12 hours of life. Neonates undergoing UCM also had higher hemoglobin, delivery room temperature, blood pressure over the first 15 hours, and urine output in the first 24 hours of life. There were no differences for the 43 infants delivered by VD.ConclusionsThis is the first randomized controlled trial demonstrating higher systemic blood flow with UCM in preterm neonates compared with DCC. UCM may be a more efficient technique to improve blood volume in premature infants delivered by CD.
| S-EPMC4485011 | biostudies-literature
Project description:BackgroundUmbilical cord milking (UCM) improves blood pressure and urine output, and decreases the need for transfusions in comparison to immediate cord clamping (ICC). The immediate effect of UCM in the first few minutes of life and the impact on neonatal resuscitation has not been described.MethodsWomen admitted to a tertiary care center and delivering before 32 weeks gestation were randomized to receive UCM or ICC. A blinded analysis of physiologic data collected on the newborns in the delivery room was performed using a data acquisition system. Heart rate (HR), SpO2, mean airway pressure (MAP), and FiO2 in the delivery room were compared between infants receiving UCM and infants with ICC.Results41 of 60 neonates who were enrolled and randomized had data from analog tracings at birth. 20 of these infants received UCM and 21 had ICC. Infants receiving UCM had higher heart rates and higher SpO2 over the first 5 minutes of life, were exposed to less FiO2 over the first 10 minutes of life than infants with ICC.ConclusionsUCM when compared to ICC had decreased need for support immediately following delivery, and in situations where resuscitation interventions were needed immediately, UCM has the advantage of being completed in a very short time to improve stability following delivery.Trial registrationClinicalTrials.gov NCT01434732.
| S-EPMC3978008 | biostudies-literature
Project description:ImportanceCompared 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.ObjectiveTo 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 participantsA 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.InterventionUCM and ECC.Main outcomes and measuresAges 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.ResultsAmong 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 relevanceIn 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 registrationClinicalTrials.gov Identifier: NCT03631940.
| S-EPMC11217871 | biostudies-literature
Project description:This is a review of umbilical cord milking, a controversial technique where the umbilical cord is squeezed several times before it is clamped an cut. While not physiological or natural for newborns, the question lies as to whether it is useful in certain circumstances, namely the depressed newborn. Here we review the literature and discuss why it could be considered as an alternative for the current practice of delayed cord clamping.
| S-EPMC6249997 | biostudies-literature
Project description:ObjectiveTo compare the effect of umbilical cord milking vs delayed cord clamping (DCC) on neurodevelopmental and health outcomes in very preterm infants at 22-26 months of corrected age.Study designNeurodevelopmental outcomes at 2 years of age were assessed using the Bayley Scales of Infant Development, third edition, and a standardized neurologic examination. Data regarding pulmonary morbidities, neurosensory impairments, and hospitalizations were obtained by parental interview. Intention-to-treat was used for primary analyses.ResultsOf the 197 infants enrolled in the original study there were 15 deaths, 5 in the umbilical cord milking group and 10 in DCC group. Of the remaining infants, 135 (74%) were assessed at 22-26 months of corrected age. Demographics in umbilical cord milking (n = 70) and DCC (n = 65) groups were similar. Infants randomized to umbilical cord milking at birth had significantly higher cognitive and language composite scores, and were less likely to have a cognitive composite score of <85 (4% vs 15%; P = .04). Motor function was similar in both groups. There were no differences in the incidences of mild or moderate to severe neurodevelopmental impairment, hearing or visual impairments, pulmonary morbidities, or rehospitalizations between the 2 groups.ConclusionsInfants randomized to umbilical cord milking had higher language and cognitive scores compared with those randomized to DCC. There was no difference in rates of mild or moderate to severe neurodevelopmental impairment.Trial registrationclinicaltrials.gov: NCT01434732.
| S-EPMC9442450 | biostudies-literature
Project description:ImportanceUmbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation.ObjectiveTo determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping.Design, setting, and participantsNoninferiority randomized clinical trial of preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018.InterventionsParticipants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238).Main outcomes and measuresThe primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin.ResultsAmong 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, -2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks' gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002).Conclusions and relevanceIn this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks' gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulting post hoc nature of the analyses preclude definitive conclusions.Trial registrationClinicalTrials.gov Identifier: NCT03019367.
| S-EPMC6865839 | biostudies-literature
Project description:BackgroundDelayed cord clamping (DCC) is a placental to new-born transfusion strategy recommended by obstetric and gynaecological societies. Though not widely adopted, umbilical cord milking (UCM) may achieve faster transfusion when DCC cannot be performed such as when a neonate requires resuscitation.MethodsPragmatic, two-arm, randomized clinical trial in which consenting women in spontaneous labour or provider-initiated delivery at 28 to less than 37 weeks at Kenyatta National Hospital in Nairobi, Kenya, were enrolled. At delivery, stable preterm infants were randomized to UCM (4 times) or DCC (60 seconds). Neonatal samples were collected for analysis at 24 hours after delivery. Maternal primary PPH (within 24 hours) and neonatal jaundice (within 1 week) were evaluated clinically. The primary outcome was the mean neonatal haemoglobin level at 24 hours after birth. Modified Intention to treat analysis was used for all outcomes. P-value was significant at p<0.05.ResultsBetween March 2018 to March 2019, 344 pregnant women underwent screening, and 280 eligible participants were randomized when delivery was imminent. The intervention was not performed on 19 ineligible neonates. Of the remaining 260 neonates, 133 underwent UCM while 128 underwent DCC. Maternal and neonatal baseline characteristics were similar. The mean neonatal haemoglobin (17.1 vs 17.5 grams per decilitre, p = 0.191), haematocrit (49.6% vs 50.3%, p = 0.362), anaemia (9.8% vs 11.7%, p = 0.627), maternal PPH (2.3% vs 3.1%, p = 0.719) were similar between UCM and DCC respectfully. However, neonatal polycythaemia (2.3% vs 8.6%, p = 0.024) and neonatal jaundice (6.8% vs 15.6%, p = 0.024) were statistically significantly lower in UCM compared to DCC.ConclusionUCM compared to DCC for preterm neonates resulted in similar outcomes for neonatal haemoglobin, haematocrit, anaemia and maternal primary PPH and a lower proportion of neonatal polycythaemia and clinical jaundice. UCM offers a comparable method of placental transfusion compared to DCC and may be considered as an alternative to DCC in preterm neonates at 28 to <37 weeks' gestation.
| S-EPMC7837492 | biostudies-literature
Project description:BackgroundThe hematological impact of umbilical cord milking (UCM) was compared to that of delayed cord clamping (DCC) as a faster placental transfusion technique for preterm neonates (between 24 and 34 + 6 weeks gestation). A comparison of important neonatal morbidities was also made.MethodsThis was an open-label randomized trial conducted from June 8, 2017, to April 22, 2019. Two hundred patients with preterm deliveries (24 and 34 + 6 weeks gestation) were assigned to the DCC or UCM group at random at a ratio of 1:1. The study power was 80% for a difference in the hematocrit value of 3% and Hb value of one gram, and an alpha error of 0.05.ResultsThe following variables were analyzed in the comparison of UCM vs. DCC: first draw hemoglobin: 17.0 ± 1.9 vs. 16.8 ± 1.8 gm/dl (95% CI -0.75-0.29, P 0.383); first draw hematocrit: 55.6 ± 6.4 vs. 55.2 ± 6.4% (95% CI -2.18-1.38, P 0.659); peak hematocrit: 56.9 ± 6.4 vs. 56.3 ± 6.7% (95% CI -2.41-1.26, P 0.537); the need for respiratory assistance (47% vs. 30%, P 0.020), inotropes (16% vs. 6%, P 0.040), and blood transfusion (26% vs. 12%, P 0.018); and the occurrence of intraventricular hemorrhage (9% vs. 5%, P 0.407), necrotizing enterocolitis (6% vs. 2%, P 0.279), sepsis (25% vs. 15%, P 0.111), and neonatal death (13% vs. 4%, P 0.40).ConclusionUCM facilitated a rapid transfer of placental blood equivalent to that of DCC for premature neonates. However, it resulted in increased rates of interventions and morbidities, especially in extremely preterm neonates.Trial registrationThe clinical trial was registered on May 10, 2017, with registration number (NCT03147846).
| S-EPMC9484179 | biostudies-literature