Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial.

BACKGROUND: 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. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.

Curriculum and assessment tool for less invasive surfactant administration: an international Delphi consensus study.

BACKGROUND: Training and assessment of operator competence for the less invasive surfactant administration (LISA) procedure vary. This study aimed to obtain international expert consensus on LISA training (LISA curriculum (LISA-CUR)) and assessment (LISA assessment tool (LISA-AT)). METHODS: From February to July 2022, an international three-round Delphi process gathered opinions from LISA experts (researchers, curriculum developers, and clinical educators) on a list of items to be included in a LISA-CUR and LISA-AT (Round 1). The experts rated the importance of each item (Round 2). Items supported by more than 80% consensus were included. All experts were asked to approve or reject the final LISA-CUR and LISA-AT (Round 3). RESULTS: A total of 153 experts from 14 countries participated in Round 1, and the response rate for Rounds 2 and 3 was >80%. Round 1 identified 44 items for LISA-CUR and 22 for LISA-AT. Round 2 excluded 15 items for the LISA-CUR and 7 items for the LISA-AT. Round 3 resulted in a strong consensus (99-100%) for the final 29 items for the LISA-CUR and 15 items for the LISA-AT. CONCLUSIONS: This Delphi process established an international consensus on a training curriculum and content evidence for the assessment of LISA competence. IMPACT: This international consensus-based expert statement provides content on a curriculum for the less invasive surfactant administration procedure (LISA-CUR) that may be partnered with existing evidence-based strategies to optimize and standardize LISA training in the future. This international consensus-based expert statement also provides content on an assessment tool for the LISA procedure (LISA-AT) that can help to evaluate competence in LISA operators. The proposed LISA-AT enables standardized, continuous feedback and assessment until achieving proficiency.

A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth.

Current guidelines support the use of a cardiac monitor during neonatal resuscitation. Infants born preterm randomized to a novel electrocardiogram algorithm displayed a heart rate sooner than the conventional electrocardiogram algorithm. Although resuscitation outcomes were not different, the availability of an earlier heart rate may benefit neonatal providers during high-risk resuscitations. TRIAL REGISTRATION: ClinicalTrials.govNCT04587934.

Use of Pulse Oximetry Pulsatility Index Screening for Critical Congenital Heart Disease.

OBJECTIVE: This study aimed to compare oximetry data (pre- and postductal oxygen saturation [SpO2], pre- and postductal pulsatility index [PI]) in healthy newborns (≥35 weeks' gestational age) to infants who have critical congenital heart disease (CCHD). STUDY DESIGN: This is a retrospective analysis of data obtained from electronic medical records, recorded as part of routine pulse oximetry screening (POS) for CCHD in infants born between the years 2013 and 2020. Testing was performed at 24 ± 2 hours of life. Data were analyzed to detect differences in pre- and postductal SpO2 and pre- and postductal PI in healthy newborns compared with infants who have CCHD. Newborns were excluded from analysis if they: (1) had a prenatal diagnosis of CCHD in the medical record, (2) had previously been admitted to the neonatal intensive care unit, or (3) had failed POS but were found no CCHD by diagnostic echocardiography. RESULTS: A total of 88,754 healthy newborns had received POS between the years 2013 and 2020. Of the 88,736 newborn records available for analysis,18 newborns were diagnosed with CCHD. Eight were identified by POS before discharge and 10 were diagnosed after discharge. Infants diagnosed with CCHD by POS had lower pre- and postductal SpO2 compared with normal infants. Their postductal PI was significantly lower. Infants who had CCHD that was not identified by POS had similar pre- and postductal SpO2 values, but their postductal PI was lower. Using a postductal PI cutoff of 1.21 had a receiver operating curve of area under the curve 0.77 (95% confidence interval: 0.672, 0.869) with 74% sensitivity and 61% specificity. CONCLUSION: In our large cohort of infants born in San Diego County, the postductal PI is lower in infants with CCHD. Given that PI is routinely displayed on every pulse oximeter and the high morbidity of missed CCHD, PI should be incorporated into routine CCHD screening. KEY POINTS: · Postductal PI is lower in newborn who presented later with congenital heart disease.. · Postductal PI cut-off of 1.21 may help practitioners determine if a newborn is at risk for CCHD.. · This large cohort study demonstrates that a low PI can detect additional CCHD cases..

Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent.

OBJECTIVE: This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences. STUDY DESIGN: The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent. RESULTS: Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15-74% across six sites) of the time. CONCLUSION: PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03019367. KEY POINTS: · Waiver of consent is when informed consent cannot be obtained prior to delivery.. · Cord milking is a procedure in which blood is pushed (stripped) two to four times towards the newborn.. · Delayed clamping means the umbilical cord is not clamped immediately after birth..

Stem Cell Composition of Umbilical Cord Blood Following Milking Compared with Delayed Clamping of the Cord Appears Better Suited for Promoting Hematopoiesis.

In comparing placental transfusion strategies, blood obtained from an umbilical cord that has been "milked" vs one in which clamping was simply delayed contains mesenchymal stromal cells in addition to solely hematopoietic stem cells, a composition more favorable for hematopoiesis, as suggested by its superior rescue of lethally irradiated bone marrow-depleted mice.

Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm.

OBJECTIVE: To 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 DESIGN: Premature 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. RESULTS: Fifty-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. CONCLUSIONS: The 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 REGISTRATION: ClinicalTrials.gov: NCT03145142.

Early experience with the Micro Plug Set for preterm patent ductus arteriosus closure.

OBJECTIVES: We intend to describe early experience using a new, commercially available Micro Plug Set for preterm neonate and infant transcatheter patent ductus arteriosus (PDA) occlusion. BACKGROUND: Transcatheter PDA occlusion in premature neonates and small infants is safe and effective. The procedure is early in its evolution. METHODS: Procedural and short-term outcomes of preterm neonates and infants undergoing transcatheter PDA occlusion with a new, commercially available device were reviewed. RESULTS: Eight preterm neonates and infants born at median 27 weeks gestation (23-36 weeks) underwent transcatheter PDA device closure with the Micro Plug Set. The device is short (2.5 mm) with a range of diameters (3, 4, 5, 6 mm) and delivered through a microcatheter. Procedures were performed at median 41 days of age (12-88 days) and at 1690 g (760-3,310 g). Transvenous PDA device occlusion was performed with fluoroscopic and echocardiography guidance. All procedures were successful with complete PDA occlusion. There were no procedural or short-term adverse events. CONCLUSIONS: Preterm neonate and infant transcatheter PDA device closure with a new, commercially available short and microcatheter delivered device (Micro Plug Set) was safe and effective in a small, early series of patients.

Unintentional Manganese Delivery in Neonatal Parenteral Nutrition.

Iatrogenic manganese (Mn) neurotoxicity is a safety concern in neonates receiving parenteral nutrition (PN). Prior studies suggest Mn contamination of PN ingredients represents an unintended source of Mn delivery. In order to determine the relative contribution of unsourced Mn to total Mn exposure in neonatal PN, this study measured Mn concentrations in neonatal PN solutions using inductively coupled plasma mass spectrometry. Solutions prepared using a standard fixed dose neonatal multiple trace element product were compared with test solutions prepared using individual trace element ingredients not including Mn. The standard solutions (n = 6) contained a mean (SD) Mn concentration of 56.63 µg/L (0.94), compared with 6.04 µg/L (0.39) in the test solutions without added Mn (n = 6). This study suggests that neonatal PN contains significant quantities of Mn not intentionally added during PN preparation. Further studies are needed to identify individual ingredient sources of unintentional Mn, and the feasibility of Mn omission strategies.

The Neu-Prem Trial: Neuromonitoring of Brains of Infants Born Preterm During Resuscitation-A Prospective Observational Cohort Study.

OBJECTIVE: To determine whether monitoring cerebral oxygen tissue saturation (StO2) with near-infrared spectroscopy (NIRS) and brain activity with amplitude-integrated electroencephalography (aEEG) can predict infants at risk for intraventricular hemorrhage (IVH) and death in the first 72 hours of life. STUDY DESIGN: A NIRS sensor and electroencephalography leads were placed on 127 newborns <32 weeks of gestational age at birth. Ten minutes of continuous NIRS and aEEG along with heart rate, peripheral arterial oxygen saturation, fraction of inspired oxygen, and mean airway pressure measurements were obtained in the delivery room. Once the infant was transferred to the neonatal intensive care unit, NIRS, aEEG, and vital signs were recorded until 72 hours of life. An ultrasound scan of the head was performed within the first 12 hours of life and again at 72 hours of life. RESULTS: Thirteen of the infants developed any IVH or died; of these, 4 developed severe IVH (grade 3-4) within 72 hours. There were no differences in either cerebral StO2 or aEEG in the infants with low-grade IVH. Infants who developed severe IVH or death had significantly lower cerebral StO2 from 8 to 10 minutes of life. CONCLUSIONS: aEEG was not predictive of IVH or death in the delivery room or in the neonatal intensive care unit. It may be possible to use NIRS in the delivery room to predict severe IVH and early death. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02605733.

Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial.

Infants may benefit if resuscitation could be provided with an intact umbilical cord. Infants identified at risk for resuscitation were randomized to 1- or 5-minute cord clamping. The 5-minute group had greater cerebral oxygenation and blood pressure. Studies are needed to determine whether this translates into improved outcomes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02827409.

Relationship Between Near-Infrared Spectroscopy and Transabdominal Ultrasonography: Noninvasive Monitoring of Intestinal Function in Neonates.

BACKGROUND: Near-infrared spectroscopy (NIRS) has the potential to continuously and noninvasively monitor intestinal function. This technology may be valuable because among neonates, intestinal maturity is highly variable and difficult to assess based solely on clinical signs. The aim of this study was to determine if there is an association between NIRS-based StO2 measurements and peristaltic activity assessed by transabdominal ultrasonography (US). MATERIAL/METHODS: Nineteen neonates of gestational age >32 weeks were categorized according to "no/low" versus "normal/hyperactive" motility levels, based on blinded US scan results. StO2 was recorded every 2 s for 24 h, following the ultrasound recording. Differences between the resulting estimates of average StO2 (bias of fits) and goodness-of-fit (residuals) were evaluated. RESULTS: Newborns with normal/hyperactive motility had higher mean StO2 than newborns with no/low motility (72.3±4.4 vs. 65.5±7.9, p<0.05, F=5.65). Residual errors were not significantly different between the 2 groups (p=0.213, F=0.213). A multivariate linear regression model using the means, residuals, and pairwise products of both, demonstrated more significant separation (0.47±0.26 vs. -0.24±0.33, p<0.01, F=27.4). A non-linear variant of the multivariate linear regression model demonstrated greatest separation (0.68±0.24 vs. -0.49±0.53, p<0.01, F=41.9). CONCLUSIONS: This is the first study to demonstrate an association between NIRS-based StO2 measurements and peristaltic activity visualized by ultrasound imaging. NIRS may offer a continuous, noninvasive method to assess motility. This may have significant implications in premature infants at risk for feeding intolerance or necrotizing enterocolitis.

A Pilot Randomized Controlled Trial of Early versus Routine Caffeine in Extremely Premature Infants.

OBJECTIVE: This study aims to compare the effects of early and late (routine) initiation of caffeine in nonintubated preterm neonates. STUDY DESIGN: A total of 21 neonates < 29 weeks gestational age were randomized to receive intravenous caffeine citrate (20 mg/kg) or placebo either before 2 hours of age (early) or at 12 hours of age (routine). This was an observational trial to determine the power needed to reduce the need for endotracheal intubation by 12 hours of age. Other outcomes included comparisons of cerebral oxygenation, systemic and pulmonary blood flow, hemodynamics, hypotension treatment, oxygen requirement, and head ultrasound findings. RESULTS: There was no difference in the need for intubation (p = 0.08), or vasopressors (p = 0.21) by 12 hours of age. Early caffeine was associated with improved blood pressure (p = 0.03) and systemic blood flow (superior vena cava flow, p = 0.04 and right ventricular output, p = 0.03). Heart rate, left ventricular output, and stroke volume were not significantly affected. Cerebral oxygenation transiently decreased 1 hour after caffeine administration. There were no differences in other outcomes. CONCLUSION: This pilot study demonstrated the feasibility of conducting such a trial in extremely preterm neonates. We found that early caffeine administration was associated with improved hemodynamics. Larger studies are needed to determine whether early caffeine reduces intubation, intraventricular hemorrhage, and related long-term outcomes.

The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates.

OBJECTIVE: To determine whether umbilical cord milking (UCM) improves systemic blood flow and reduces neonatal morbidities compared with immediate cord clamping (ICC). STUDY DESIGN: Women admitted to a tertiary care center and delivering before 32 weeks' gestation were randomized to receive UCM or ICC. Three blinded serial echocardiograms were performed in the first 2 days of the infant's life. The primary outcome was measured systemic blood flow (superior vena cava flow) at each time point. RESULTS: Of the 60 neonates who were enrolled and randomized, 30 were assigned to cord milking and 30 to ICC. Neonates randomized to cord milking had greater measures of superior vena cava flow and right ventricular output in the first 6 hours and 30 hours of life. Neonates receiving UCM also had greater serum hemoglobin, received fewer blood transfusions, fewer days on oxygen therapy, and less frequent use of oxygen at 36 weeks' corrected postmenstrual age. CONCLUSIONS: We demonstrate greater systemic blood flow with UCM in preterm neonates compared with ICC. Future large prospective trials are needed to determine whether UCM reduces intraventricular hemorrhage and other long-term morbidities.

Chest compressions superimposed with sustained inflation during neonatal cardiopulmonary resuscitation: are we ready for a clinical trial?

Neonates requiring cardiopulmonary resuscitation (CPR) are at risk of mortality and neurodevelopmental injury. Poor outcomes following the need for chest compressions (CCs) in the delivery room prompt the critical need for improvements in resuscitation strategies. This article explores a technique of CPR which involves CCs with sustained inflation (CC+SI). Unique features of CC+SI include (1) improved tidal volume delivery, (2) passive ventilation during compressions, (3) uninterrupted compressions and (4) improved stability of cerebral blood flow during resuscitation. CC+SI has been shown in animal studies to have improved time to return of spontaneous circulation and reduced mortality without significant increase in markers of inflammation and injury in the lung and brain, compared with standard CPR. The mechanics of CCs, rate of compressions, ventilation strategies and compression-to-ventilation ratios are detailed here. A large randomised controlled trial comparing CC+SI versus the current 3:1 compression-to-ventilation ratio is needed, given the growing evidence of its potential benefits.

Application of desirability of outcome ranking to the milking in non-vigorous infants trial.

OBJECTIVES: Neonatal trials have traditionally used binary composite short-term (such as death or bronchopulmonary dysplasia) or longer-term (such as death or severe neurodevelopmental impairment) outcomes. We applied the Desirability Of Outcome Ranking (DOOR) method to rank the overall patient outcome by best (no morbidities) to worst (death). STUDY DESIGN: Using a completed large multicenter trial (Milking In Non-Vigorous Infants [MINVI]) of umbilical cord milking (UCM) vs. early cord clamping (ECC), we applied the DOOR methodology to neonatal outcomes. Six outcomes were chosen and ranked: no interventions or NICU admission (most desirable); received initial cardiorespiratory support at birth; neonatal intensive care unit (NICU) admission for predefined criteria; mild hypoxic-ischemic encephalopathy (HIE); moderate to severe HIE; and death (least desirable). RESULTS: 1524 non-vigorous newborns born between 35 and 42 weeks' gestation had data for analysis. The DOOR distribution was different between the UCM and ECC arms, with a significantly greater probability (55.8 % [95 % CI 53.1-58.5 %; p < 0.0001]) of a randomly selected neonate having a more desirable outcome if they were in the UCM arm. DOOR probabilities of averting individual adverse outcomes such as NICU admission for predefined criteria (52.8 %; 95%CI 50.5-55.1 %) and cardiorespiratory support (54.0 %; 95%CI 51.6-56.4 %) were significantly higher among those in the UCM group. CONCLUSION: DOOR provides an overall assessment of the benefits and harms with greater insight than typical binary composite measures to clinicians and parents when evaluating an intervention. Future neonatal trials should consider the a priori use of the DOOR methodology to evaluate trial outcomes.

Parental perspectives on a trial using waived informed consent at birth.

OBJECTIVES: To determine parental perspectives in a trial with waived consent. STUDY DESIGN: Anonymous survey of birth parents with term infants who were randomized using a waiver of consent, administered after infant discharge. RESULTS: 121 (11%) survey responses were collected. Of the 121 responding parents 111 (92%) reported that this form of consent was acceptable and 116 (96%) reported feeling comfortable having another child participate in a similar study. 110 (91%) respondents reported that they both understood the information provided in the consent process and had enough time to consider participation. Four percent had a negative opinion on the study's effect on their child's health. CONCLUSIONS: Most responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child's health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.

Optimizing transition: Providing oxygen during intact cord resuscitation.

Delayed clamping and cutting of the umbilical cord at birth is standard practice for management for all newborns. Preterm infants may additionally benefit from a combination of ventilation and oxygen provision during intact cord resuscitation. This review highlights both the potential benefits of such a combined approach and the need for further rigorous studies, including randomized controlled trials, of delivery room management in this population.

Maternal bleeding complications and neonatal outcomes following early versus delayed umbilical cord clamping in cesarean deliveries for very low birthweight infants.

OBJECTIVE: Determine effect of at least 60 s delayed cord clamping (DCC) on postpartum hemorrhage and maternal estimated blood loss (EBL) in very low birth weight (VLBW) cesarean deliveries when compared to early cord clamping (ECC). STUDY DESIGN: Retrospective study of VLBW infants at birth. Maternal pre- and post-operative hemoglobin, EBL, and neonatal outcomes were collected. RESULTS: In total, 620 VLBW infants (DCC = 166, ECC = 454) born to 545 mothers (DCC = 155, ECC = 390) were included. Maternal PPH between DCC was 8% versus ECC was 10% p = 0.52. There were no differences in estimated blood loss or rate of maternal blood transfusion between groups. The post-operative hemoglobin was lower in infants receiving ECC compared to DCC (10.4 [9.4-11.5] versus 10.8 [10.1-11.9] g/dl, p = 0.01). In comparing pre-operative to post-operative hemoglobin there was no difference between DCC and ECC (-1.2 [-2.0 to -0.3] versus -1.2 [-2.1 to -0.6] g/dl, p = 0.46). CONCLUSION: DCC of at least 60 s did not increase maternal bleeding complications during VLBW cesarean delivery. To our knowledge, this retrospective study is the largest sample size to date of preterm cesarean deliveries to support maternal safety regarding bleeding complications after delayed cord clamping.