Barriers to deferred cord clamping in preterm infants.
Ontology highlight
ABSTRACT: Objectives
To describe the range of practices employed by units conducting deferred cord clamping at very preterm birth.Design
Qualitative study using semistructured interviews with neonatal doctors, nurses, midwives, obstetricians and managers in a sample of UK maternity units.Participants
33 neonatal doctors, neonatal nurses, midwives, obstetricians and managers.Setting
UK maternity units in 2012.Results
Four key themes emerged. The first concerns the variation in guideline content, the absence of a practice of stabilisation with cord intact, and issues with implementing and maintaining changes in practice. The second concerns the challenges in assessing eligibility. The third concerns the competing priorities of delivering the intervention and proceeding with other stabilisation manoeuvres and the associated anxiety experienced by professionals. The final theme relates to the issue of uncertainty as to optimal treatment choices.Conclusions
The evidence surrounding deferred cord clamping in very preterm infants is unclear. This study describes the reported practice of units deferring cord clamping in 2012 and will inform trial development.
SUBMITTER: Oddie S
PROVIDER: S-EPMC4145419 | biostudies-literature | 2014 Sep
REPOSITORIES: biostudies-literature
Publications
Barriers to deferred cord clamping in preterm infants.
Archives of disease in childhood. Fetal and neonatal edition 20140605 5
<h4>Objectives</h4>To describe the range of practices employed by units conducting deferred cord clamping at very preterm birth.<h4>Design</h4>Qualitative study using semistructured interviews with neonatal doctors, nurses, midwives, obstetricians and managers in a sample of UK maternity units.<h4>Participants</h4>33 neonatal doctors, neonatal nurses, midwives, obstetricians and managers.<h4>Setting</h4>UK maternity units in 2012.<h4>Results</h4>Four key themes emerged. The first concerns the va ...[more]
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Project description:BACKGROUND AND OBJECTIVE:Delayed 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. METHODS:This 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. RESULTS:A 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. CONCLUSIONS:This 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:ObjectiveTo evaluate changes in cerebral oxygenation, peripheral arterial oxygenation, respiratory status, and administered fraction of inspired oxygen during the first 10 minutes of life in premature infants receiving umbilical cord milking compared with delayed cord clamping (DCC).Study designPremature infants born at 230/7 to 276/7 weeks of gestation were randomized to umbilical cord milking or DCC. A near infrared spectroscopy sensor, pulse oximeter, and electrocardiogram electrodes were placed. Pulse rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and fraction of inspired oxygen were collected for 10 minutes in the delivery room. Longitudinal models were used to compare effects of umbilical cord milking and DCC.ResultsFifty-six infants had cerebral oximetry and advanced monitoring at birth. There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211). Longitudinal models suggested that peripheral oxygen saturation was higher in the umbilical cord milking group in the first 4 minutes (P = .0221) and that mean airway pressures were lower in the umbilical cord milking group after the first 7 minutes (P = .0072). No statistical differences were observed for fraction of inspired oxygen, cerebral tissue oxygenation, or heart rates.ConclusionsThe data suggest that the rapid transfer of blood during umbilical cord milking may facilitate lung expansion with improved pulmonary blood flow, but may also increase cerebral blood flow, resulting in severe intraventricular hemorrhage.Trial registrationClinicalTrials.gov: NCT03145142.
| S-EPMC7387184 | biostudies-literature
Project description:BackgroundPlacental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes.ObjectivesTo assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery.Search methodsWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.Selection criteriaRandomized, cluster randomized, or quasi-randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping.Data collection and analysisAll review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information.Main resultsOne study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs.Authors' conclusionsThe results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful.
| S-EPMC6494179 | 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:Deferred cord clamping (DCC) has been associated with reduced mortality in preterm infants, and a period of at least 30 s has been recommended before clamping. However, preterm infants assessed as being in need of resuscitation have often had earlier cord clamping. In this study, we aimed to compare neonatal outcomes for preterm infants undergoing DCC who established early breathing movements compared to those who were not breathing. After a 5 yr recruitment period, we recently completed the ABC study, in which preterm infants <31 weeks undergoing 50 s of DCC who were not breathing by 15 s of age were randomised into two groups: one received intermittent positive pressure ventilation (IPPV) and the other was a standard group, which received no breathing support. The outcomes in the two groups were similar, and for the present analysis, the groups were combined. Infants in the ABC study were compared with the cohort excluded from the original ABC study because they were breathing by 15 s (called the Breathing Before Clamping or BBC group). There were significant differences in demographics between the ABC and BBC groups. Spontaneous preterm labour was more common in the BBC group, and these infants were more likely to be delivered vaginally. Gestational age and birth weight were significantly higher in the BBC group (p < 0.01). Soon after birth, Apgar scores were significantly higher in the BBC group, with a lower base deficit on first obtained blood gas, and a smaller proportion were intubated in the delivery room. Fewer BBC infants were hypothermic (<36.5 °C) on admission. Multivariate regression analysis indicated whether infants were breathing or not at 15 s of age was linked predominantly to gestation. Important neonatal outcomes and a composite of these outcomes (mortality, severe intraventricular haemorrhage, bronchopulmonary dysplasia) were not significantly different between the ABC and BBC groups (odds ratio for the composite outcome was 1.77 CI 0.84-3.76 corrected for gestation). For very preterm infants undergoing DCC, important neonatal outcomes were related to gestational age and not independently associated with early breathing. There was a small group (7% of total) who were deemed compromised at birth and did not undergo DCC. These infants had significantly worse neonatal outcomes.
| S-EPMC10968951 | biostudies-literature
Project description:BackgroundOptimum timing of umbilical cord clamping has not been established in preterm infants.ObjectivesWe compared the short- and long-term effects of umbilical cord milking (UCM) versus delayed cord clamping (DCC) on infants born at less than 37 weeks of gestation.Search methodsA systematic review and meta-analysis was conducted according to the "Preferred Reporting Items for Systematic Reviews and Meta-Analyses" statement. We searched CINAHL, CENTRAL, EMBASE, MEDLINE, PubMed and ClinicalTrials.gov for relevant randomized controlled trials (RCTs).Selection criteriaWe included individual and clustered RCTs comparing UCM to DCC for infants born before 37 weeks of gestation.Data collection and analysisFour reviewers independently assessed trial quality and eligibility for inclusion.Main resultsTwo trials (255 preterm infants, 23 0/7 to 32 6/7 weeks of gestation) were included in the analysis. UCM was associated with fewer intraventricular hemorrhages (IVHs) (two trials, 255 infants; relative risk [RR] 0.45, 95% confidence interval [CI] 0.20 to 0.98, low quality of evidence) and UCM was an increased proportion of infants with a Bayley score at 2 years of age (two trials, 174 infants; Cognitive: RR 1.14, 95% CI 1.03 to 1.26, Language: RR 1.24, 95% CI 1.03 to 1.49, low quality of evidence) compared to DCC.ConclusionsUCM wasn't reduced in-hospital mortality and need for transfusion compared to DCC. But our study suggests that UCM may lower the risk of IVH and improve certain neurodevelopmental outcomes compared to DCC in preterm infants.
| S-EPMC6116944 | biostudies-literature
Project description:BackgroundMortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor for these complications is hemodynamic instability. Pre-clinical studies suggest that the timing of umbilical cord clamping affects hemodynamic stability during transition. Standard care is time-based cord clamping (TBCC), with clamping irrespective of lung aeration. It is unknown whether delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) is more beneficial. This document describes the statistical analyses for the ABC3 trial, which aims to assess the efficacy and safety of PBCC, compared to TBCC.MethodsThe ABC3 trial is a multicenter, randomized trial investigating PBCC (intervention) versus TBCC (control) in very preterm infants. The trial is ethically approved. Preterm infants born before 30 weeks of gestation are randomized after parental informed consent. The primary outcome is intact survival, defined as the composite of survival without major cerebral injury and/or NEC. Secondary short-term outcomes are co-morbidities and adverse events assessed during NICU admission, parental reported outcomes, and long-term neurodevelopmental outcomes assessed at a corrected age of 2 years. To test the hypothesis that PBCC increases intact survival, a logistic regression model will be estimated using generalized estimating equations (accounting for correlation between siblings and observations in the same center) with treatment and gestational age as predictors. This plan is written and submitted without knowledge of the data.DiscussionThe findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth.Trial registrationClinicalTrials.gov NCT03808051. Registered on 17 January 2019.
| S-EPMC10913647 | biostudies-literature
Project description:Delayed cord clamping (DCC) has been advocated during preterm delivery to improve hemodynamic stability during the early neonatal period. The hemodynamic effects of DCC in premature infants after birth have not been previously examined. Our objective was to compare the hemodynamic differences between premature infants randomized to either DCC or immediate cord clamping (ICC).This prospective study was conducted on a subset of infants who were enrolled in a randomized controlled trial to evaluate the effects of DCC versus ICC. Entry criteria included gestational ages of 24(0) to 31(6) weeks. Twins and infants of mothers with substance abuse were excluded. Serial Doppler studies were performed at 6 ± 2, 24 ± 4, 48 ± 6, and 108 ± 12 hours of life. Measurements included superior vena cava blood flow, right ventricle output, middle cerebral artery blood flow velocity (BFV), superior mesenteric artery BFV, left ventricle shortening fraction, and presence of a persistent ductus arteriosus.Twenty-five infants were enrolled in the DCC group and 26 in the ICC group. Gestational age, birth weight, and male gender were similar. Admission laboratory and clinical events were also similar. DCC resulted in significantly higher superior vena cava blood flow over the study period, as well as greater right ventricle output and right ventricular stroke volumes at 48 hours. No differences were noted in middle cerebral artery BFV, mean superior mesenteric artery BFV, shortening fraction, or the incidence of a persistent ductus arteriosus.DCC in premature infants is associated with potentially beneficial hemodynamic changes over the first days of life.
| S-EPMC3356138 | 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:Objective:To describe haematocrit at birth in preterm infants who received ?60?s of delayed cord clamping (DCC). Design:Retrospective observational study. Setting:A California public hospital with an American Academy of Pediatrics level 4 neonatal intensive care unit, with 3500-4000 deliveries annually. Participants:467 preterm infants born at <35 weeks' gestational age (GA) between January 2013 and December 2018. Primary and secondary outcome measures:Haematocrit reference ranges for 0-4?hours after birth and paired haematocrit differences between 0-4 and 4-24?hours. Methods:Haematocrits were obtained when clinically indicated and collected from arterial, venous and capillary sources. Haematocrits obtained after packed red blood cell transfusions were excluded. We summarised the first available haematocrit between 0 and 4?hours by GA strata. We used mixed-effects linear regression to describe the associations between haematocrit and predictor variables including GA, male sex and hours after an infant's birth. We also compared paired haematocrits at 0-4 and 4-24?hours after birth. Results:The median GA of the 467 included infants was 33.3 weeks, birth weight was 1910 g and DCC duration was 60?s. The mean (95% CI) first haematocrit at 0-4?hours was 46.6 (45.0% to 48.1%), 51.2 (49.6% to 52.8%), 50.6 (49.1% to 52.1%), 54.3 (52.8% to 55.8%) and 55.6 (54.6% to 56.6%) for infants 23-29, 30-31, 32, 33 and 34 weeks' GA strata, respectively. The subanalysis of 174 infants with paired haematocrits at 0-4 and 4-24?hours showed that for each additional hour after birth, the mean (95%?CI) haematocrit increased by 0.2 (0.1% to 0.3%), 0.2 (0.1% to 0.4%) and 0.1 (0.0% to 0.2%) for infants in 23-29, 30-31 and 32 weeks' GA strata, respectively. The subanalysis showed no change between the paired haematocrits in the 33 and 34?weeks' GA strata. Conclusions:Our study describes haematocrit in preterm infants who received ?60?s DCC as standard of care. Haematocrit during the first 0-4?hours in our study is higher than the previously described reference ranges prior to DCC becoming routine clinical practice. The paired second haematocrit at 4-24?hours is higher than haematocrit at 0-4?hours.
| S-EPMC6782040 | biostudies-literature