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Haematocrit in <35 weeks preterm infants who received at least 60 seconds of delayed cord clamping: a retrospective observational study.

ABSTRACT: 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.

SUBMITTER: Nudelman MJ

PROVIDER: S-EPMC6782040 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Haematocrit in <35 weeks preterm infants who received at least 60 seconds of delayed cord clamping: a retrospective observational study.

Nudelman Matthew Jr MJ Goel Keshav K Jegatheesan Priya P Song Dongli D Huang Angela A Govindaswami Balaji B

BMJ paediatrics open 20190924 1

<h4>Objective</h4>To describe haematocrit at birth in preterm infants who received ≥60 s of delayed cord clamping (DCC).<h4>Design</h4>Retrospective observational study.<h4>Setting</h4>A California public hospital with an American Academy of Pediatrics level 4 neonatal intensive care unit, with 3500-4000 deliveries annually.<h4>Participants</h4>467 preterm infants born at <35 weeks' gestational age (GA) between January 2013 and December 2018.<h4>Primary and secondary outcome measures</h4>Haemato ...[more]

PMID: 31646196

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Project description:BackgroundGlobally, the majority of newborns requiring resuscitation at birth are full term or late-preterm infants. These infants typically have their umbilical cord clamped early (ECC) before moving to a resuscitation platform, losing the potential support of the placental circulation. Physiologically based cord clamping (PBCC) is clamping the umbilical cord after establishing lung aeration and holds promise as a readily available means of improving early newborn outcomes. In mechanically ventilated lambs, PBCC improved cardiovascular stability and reduced hypoxia. We hypothesised that PBCC compared to ECC would result in higher heart rate (HR) in infants needing resuscitation, without compromising safety.Methods and findingsBetween 4 July 2018 and 18 May 2021, infants born at ≥32+0 weeks' gestation with a paediatrician called to attend were enrolled in a parallel-arm randomised trial at 2 Australian perinatal centres. Following initial stimulation, infants requiring further resuscitation were randomised within 60 seconds of birth using a smartphone-accessible web link. The intervention (PBCC) was to establish lung aeration, either via positive pressure ventilation (PPV) or effective spontaneous breathing, prior to cord clamping. The comparator was early cord clamping (ECC) prior to resuscitation. The primary outcome was mean HR between 60 to 120 seconds after birth, measured using 3-lead electrocardiogram, extracted from video recordings blinded to group allocation. Nonrandomised infants had deferred cord clamping (DCC) ≥120 seconds in the observational study arm. Among 508 at-risk infants enrolled, 123 were randomised (n = 63 to PBCC, n = 60 to ECC). Median (interquartile range, IQR) for gestational age was 39.9 (38.3 to 40.7) weeks in PBCC infants and 39.6 (38.4 to 40.4) weeks in ECC infants. Approximately 49% and 50% of the PBCC and ECC infants were female, respectively. Five infants (PBCC = 2, ECC = 3, 4% total) had missing primary outcome data. Cord clamping occurred at a median (IQR) of 136 (126 to 150) seconds in the PBCC arm and 37 (27 to 51) seconds in the ECC arm. Mean HR between 60 to 120 seconds after birth was 154 bpm (beats per minute) for PBCC versus 158 bpm for ECC (adjusted mean difference -6 bpm, 95% confidence interval (CI) -17 to 5 bpm, P = 0.39). Among 31 secondary outcomes, postpartum haemorrhage ≥500 ml occurred in 34% and 32% of mothers in the PBCC and ECC arms, respectively. Two hundred ninety-five nonrandomised infants (55% female) with median (IQR) gestational age of 39.6 (38.6 to 40.6) weeks received DCC. Data from these infants was used to create percentile charts of expected HR and oxygen saturation in vigorous infants receiving DCC. The trial was limited by the small number of infants requiring prolonged or advanced resuscitation. PBCC may provide other important benefits we did not measure, including improved maternal-infant bonding and higher iron stores.ConclusionsIn this study, we observed that PBCC resulted in similar mean HR compared to infants receiving ECC. The findings suggest that for infants ≥32+0 weeks' gestation who receive brief, effective resuscitation at closely monitored births, PBCC does not provide additional benefit over ECC (performed after initial drying and stimulation) in terms of key physiological markers of transition. PBCC was feasible using a simple, low-cost strategy at both cesarean and vaginal births. The percentile charts of HR and oxygen saturation may guide clinicians monitoring the transition of at-risk infants who receive DCC.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000621213.

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.

Dataset Information

Haematocrit in <35 weeks preterm infants who received at least 60 seconds of delayed cord clamping: a retrospective observational study.

Publications

Haematocrit in <35 weeks preterm infants who received at least 60 seconds of delayed cord clamping: a retrospective observational study.

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