Delayed Cord Clamping with Oxygen for Premature Birth (DOXIE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen ByAnup Katheria, MD
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sharp HealthCare
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests whether giving preterm babies different oxygen levels while delaying umbilical cord clamping helps them breathe better. It focuses on very early preterm infants who often have trouble breathing. The goal is to see which method helps these babies get enough oxygen in their blood more quickly.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Delayed Cord Clamping with Oxygen for Premature Birth?
Research suggests that physiological-based cord clamping (PBCC), which is part of the treatment, helps stabilize blood flow and improve outcomes in very preterm infants by allowing better lung and heart function. Additionally, delayed umbilical cord clamping is known to increase blood volume in newborns, which can be beneficial for premature babies.
12345Is delayed cord clamping safe for premature infants?
The research on delayed cord clamping (DCC) in preterm infants suggests it is generally safe, as it does not increase the need for inotropic support (medications that help the heart pump blood) or affect mean arterial blood pressure (average blood pressure in the arteries).
678910How is the treatment of delayed cord clamping with oxygen for premature birth different from other treatments?
Delayed cord clamping with oxygen for premature birth is unique because it involves waiting to clamp the umbilical cord until the baby's lungs are working properly, which helps stabilize blood flow and reduce potential brain injury. This approach, known as physiological-based cord clamping (PBCC), contrasts with immediate cord clamping and aims to improve the baby's transition to life outside the womb.
1251112Eligibility Criteria
This trial is for preterm infants born up to 28+6 weeks gestational age, from any type of delivery and pregnancy. It's not for those with early membrane rupture before 20 weeks, congenital anomalies, fetal/maternal compromise, or if parents decline consent or resuscitation.Inclusion Criteria
I am currently 28 weeks and 6 days pregnant or less.
Exclusion Criteria
My twins share a placenta and have twin-to-twin transfusion syndrome.
I have been diagnosed with bleeding accreta.
Participant Groups
The study compares two groups of extremely premature babies during delayed cord clamping: one receives high oxygen concentration (100%) and the other low oxygen concentration (30%), to see which helps achieve better oxygen levels by 5 minutes after birth.
2Treatment groups
Experimental Treatment
Active Control
Group I: DCC and High Oxygen ConcentrationExperimental Treatment1 Intervention
During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 1.0, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.
Group II: DCC and Low Oxygen ConcentrationActive Control1 Intervention
During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 .30, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.
Delayed Cord Clamping with High Oxygen concentration is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Delayed Umbilical Cord Clamping for:
- Preterm infants for improved transitional circulation, better establishment of red blood cell volume, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage
🇺🇸 Approved in United States as Delayed Umbilical Cord Clamping for:
- Term and preterm infants for improved hemoglobin levels, iron stores, and developmental outcomes, and reduced risk of intraventricular hemorrhage and necrotizing enterocolitis
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of California San Diego Jacobs Medical CenterSan Diego, CA
University of California DavisDavis, CA
Sharp Mary Birch Hospital for Women and NewbornsSan Diego, CA
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Who is running the clinical trial?
Sharp HealthCareLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
Sharp Mary Birch Hospital for Women & NewbornsCollaborator
References
Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-study protocol for a multicentre randomised controlled trial. [2022]International guidelines recommend delayed umbilical cord clamping (DCC) up to 1 min in preterm infants, unless the condition of the infant requires immediate resuscitation. However, clamping the cord prior to lung aeration may severely limit circulatory adaptation resulting in a reduction in cardiac output and hypoxia. Delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) allows for an adequately established pulmonary circulation and results in a more stable circulatory transition. The decline in cardiac output following time-based delayed cord clamping (TBCC) may thus be avoided. We hypothesise that PBCC, compared to TBCC, results in a more stable transition in very preterm infants, leading to improved clinical outcomes. The primary objective is to compare the effect of PBCC on intact survival with TBCC.
Physiologically based cord clamping stabilises cardiac output and reduces cerebrovascular injury in asphyxiated near-term lambs. [2018]Physiologically based cord clamping (PBCC) has advantages over immediate cord clamping (ICC) during preterm delivery, but its efficacy in asphyxiated infants is not known. We investigated the physiology of PBCC following perinatal asphyxia in near-term lambs.
Physiological-based cord clamping in very preterm infants - Randomised controlled trial on effectiveness of stabilisation. [2021]To test whether stabilising very preterm infants while performing physiological-based cord clamping (PBCC) is at least as effective as the standard approach of time-based delayed cord clamping (DCC).
Extrauterine Placental Perfusion and Oxygenation in Infants With Very Low Birth Weight: A Randomized Clinical Trial. [2023]An extrauterine placental perfusion (EPP) approach for physiological-based cord clamping (PBCC) may support infants with very low birth weight (VLBW) during transition without delaying measures of support.
Delayed umbilical cord clamping in premature neonates. [2022]Delayed umbilical cord clamping is reported to increase neonatal blood volume. We estimated the clinical outcomes in premature neonates who had delayed umbilical cord clamping compared with a similar group who had early umbilical cord clamping.
Delayed cord clamping and inotrope use in preterm infants. [2019]To evaluate the impact of delayed cord clamping (DCC) on need for inotropic support and mean arterial blood pressure (MABP).
Cochrane Update: Effect of timing of umbilical cord clamping at birth of term infants on mother and baby outcomes. [2022]Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds after birth, whereas later cord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased.
Safety of Normothermic Cardiopulmonary Bypass in Pediatric Cardiac Surgery: A System Review and Meta-Analysis. [2022]Objectives: Hypothermic cardiopulmonary bypass (HCPB) has been used successfully in cardiac surgery for more than half a century, although adverse effects have been reported with its use. Many studies on temperature management during CPB published to date have shown that normothermic CPB (NCPB) provides more benefits to children undergoing cardiac surgery. The present meta-analysis investigated the effect of NCPB on clinical outcomes based on results of randomized controlled trials and observational studies on pediatric cardiac surgery. Methods: Databases such as PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Clinical Trials.gov were searched from inception to May 2021 to identify relevant studies published in English. Results: The present meta-analysis included 13 studies characterizing a total of 837 pediatric patients. The random effects model exhibited that the NCPB group had reduced revision for postoperative bleeding [odds ratio (OR): 0.11; 95% confidence interval (CI): 0.01-0.89; I 2 = 0%, P = 0.04], serum lactate 2-4 h after CPB (mean difference: -0.60; 95% CI: -1.09 to -0.11; I 2 = 82%, P = 0.02), serum creatinemia 24 h after CPB (mean difference: -2.73; 95% CI: -5.06 to -0.39; I 2 = 83%, P = 0.02), serum creatinemia 48 h after CPB (mean difference: -2.08; 95% CI: -2.78 to -1.39; I 2 = 0%, P < 0.05), CPB time (mean difference: -19.10, 95% CI: -32.03 to -6.18; I 2 = 96%, P = 0.04), and major adverse events (OR: 0.37; 95% CI: 0.15-0.93; Z = 2.12, P = 0.03) after simple congenital surgery compared with the HCPB group. Conclusion: NCPB is as safe as HCPB in pediatric congenital heart surgery. Moreover, NCPB provides more advantages than HCPB in simple congenital heart surgery.
Intrauterine pregnancy and aortic valve replacement. [2019]Cardiopulmonary bypass (CPB) does not appear to cause excessive maternal risk, but the potential for fetal complications is of great concern. In general, operative intervention should be delayed until at least the second trimester. When this is not possible, ethical issues arise and a clash of maternal autonomy versus "fetal rights" ensues. This conflict is further complicated by maternal status changes that may accompany valvular disease or develop after CPB. The case described herein summarizes and discusses these conflicts.
Active internal re-warming using a centrifugal pump and heat exchanger following haemorrhagic shock, surgical trauma and hypothermia in a porcine model. [2008]The centrifugal vortex blood pump (CVBP) using heparin-bonded circuitry allows re-warming of hypothermic trauma patients without anticoagulation. Study objectives were to confirm efficacy, and to characterise the physiology of CVBP re-warming in a porcine model.
Delayed cord clamping does not affect umbilical cord blood gas analysis. [2020]Although delayed umbilical cord clamping has been shown to have significant benefits for both term and preterm infants, currently, data on its impact on blood gas analysis have been scant and conflicting.
Effects of delayed compared with early umbilical cord clamping on maternal postpartum hemorrhage and cord blood gas sampling: a randomized trial. [2013]To investigate the effect of delayed cord clamping (DCC) compared with early cord clamping (ECC) on maternal postpartum hemorrhage (PPH) and umbilical cord blood gas sampling.