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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04413097
Other study ID # DOXIE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 17, 2021
Est. completion date June 1, 2026

Study information

Verified date January 2024
Source Sharp HealthCare
Contact Anup Katheria, MD
Phone 858-939-4170
Email anup.katheria@sharp.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).


Description:

Prenatal consent will be obtained on infant's with estimated gestational age up to 28+6 weeks. Shortly before delivery, infant's will be randomly assigned to receive either Low oxygen concentration (FiO2 .30) OR High oxygen concentration (FiO2 1.0) during 90 seconds of delayed cord clamping. Randomization and intervention will remain blinded to the clinical care team during the entire study period. The research team member will open a randomization card when notified of a subject's impending birth, review the protocol with the obstetric provider performing the procedure, set-up the sterile stabilization bed, and note the time it takes from delivery until the clamping and cutting of the umbilical cord in both groups. The research team member will set the oxygen blender as indicated by the randomization card and cover the blender to blind the FiO2 setting. The research team member will not be involved in the clinical care of the infant. The oxygen blender will be concealed from the clinical care team to ensure resuscitation maneuvers will not be biased. Data will be submitted to the statistician, who will remain blinded to the intervention for the duration of the study. At delivery, the infant will be placed on a platform that allows the infant to be close to the mother and the umbilical cord to remain intact for DCC. These beds are equipped with an oxygen blender, humidifier, t-piece resuscitator with mask, necessary to provide CPAP/PPV. At some centers the bed will be equipped with a radian warmer (Ceramotherm, Wyer GmbH, Germany) to maintain thermoregulation on the infant during delayed cord clamping. If an infant is randomized to the DCC and Low Oxygen concentration (DCC LO group), the following procedure will ensue: During delayed cord clamping, the infant will be gently stimulated by drying the infant with a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping, breathing assistance with CPAP of 5 cm H20 and a FiO2 0.3 will be provided. If an infant is randomized to the DCC and High Oxygen concentration (DCC HI group), the following procedure will ensue: During delayed cord clamping, the infant will be gently stimulated by drying the infant with a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping, breathing assistance with CPAP of 5 cm H20 and a FiO2 1.0 will be provided. Patency of the airway in both groups will be assessed by a Colorimetric CO2 detector. Lack of color change will indicate that the airway is not patent (obstructed), the pressure is not sufficient to expand the lungs, there was excessive air leak, or there was no or inadequate pulmonary blood flow. If there is no color change, the neonatal provider will reposition and reattempt to open the airway, if no improvement they will initiate PPV (starting PIP of 20 cm H20) by 60 seconds of life. Cord clamping will occur at 90 seconds or greater and the infant will be transferred to a standard neonatal warmer and resuscitated per NRP guidelines. Additionally, when available heart rate data will be collected using a non-invasive dry-electrode monitor, (NeoBeat, Laerdal Medical, Stavanger, Norway) and applied over the infant's chest or abdomen to provide continuous display of heart rate during 90 seconds of DCC. Pulse oximetry, ECG sensors and Near-Infrared Spectroscopy (NIRS) sensors will be applied after cord clamping. The NIRS sensor will be placed on the infant's forehead. Cerebral StO2, SpO2, blood pressure (once in the NICU) and Heart rate will be recorded every two seconds and linked with other variables. These variables will continue to be recorded for the first 24 hours of life. Blood sample will be collected at two different time points: Cord blood sample (T1: Cord blood collected after the cord is cut) and at 2 hours of life or NICU admission (T2). This is extra few drops of blood that is drawn from the baby for medical purposes (cord blood from cord gases and admission blood work up). Samples will be tested for oxidized and reduced glutathione which are the most reliable and comprehensive biomarkers of oxidative stress.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date June 1, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Weeks to 28 Weeks
Eligibility Inclusion Criteria: - up to 28+6 weeks Gestational age - Single and Multiple pregnancy - All modes of delivery (vaginally or caesarean section) Exclusion Criteria: - Parents decline consent - Congenital anomalies of the newborn - Bleeding Accreta - Monochorionic multiples with evidence of TTTS - Fetal or maternal risk (i.e. compromise) - Preterm Premature Rupture of Membranes prior to 20 weeks gestation - Parents request no resuscitation

Study Design


Intervention

Procedure:
Delayed Cord Clamping with Low Oxygen concentration
During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and low oxygen concentration (FiO2 0.30) will be provided.
Delayed Cord Clamping with High Oxygen concentration
During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and high oxygen concentration (FiO2 1.0) will be provided.

Locations

Country Name City State
United States University of California Davis Davis California
United States Sharp Mary Birch Hospital for Women and Newborns San Diego California

Sponsors (3)

Lead Sponsor Collaborator
Sharp HealthCare Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sharp Mary Birch Hospital for Women & Newborns

Country where clinical trial is conducted

United States, 

References & Publications (59)

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Hooper SB, Te Pas AB, Lang J, van Vonderen JJ, Roehr CC, Kluckow M, Gill AW, Wallace EM, Polglase GR. Cardiovascular transition at birth: a physiological sequence. Pediatr Res. 2015 May;77(5):608-14. doi: 10.1038/pr.2015.21. Epub 2015 Feb 4. — View Citation

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Katheria A, Poeltler D, Durham J, Steen J, Rich W, Arnell K, Maldonado M, Cousins L, Finer N. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial. J Pediatr. 2016 Nov;178:75-80.e3. doi: 10.1016/j.jpeds.2016.07.053. Epub 2016 Aug 26. — View Citation

Katheria A, Reister F, Essers J, Mendler M, Hummler H, Subramaniam A, Carlo W, Tita A, Truong G, Davis-Nelson S, Schmolzer G, Chari R, Kaempf J, Tomlinson M, Yanowitz T, Beck S, Simhan H, Dempsey E, O'Donoghue K, Bhat S, Hoffman M, Faksh A, Arnell K, Rich W, Finer N, Vaucher Y, Khanna P, Meyers M, Varner M, Allman P, Szychowski J, Cutter G. Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants. JAMA. 2019 Nov 19;322(19):1877-1886. doi: 10.1001/jama.2019.16004. — View Citation

Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16. — View Citation

Katheria AC, Harbert MJ, Nagaraj SB, Arnell K, Poeltler DM, Brown MK, Rich W, Hassen KO, Finer N. The Neu-Prem Trial: Neuromonitoring of Brains of Infants Born Preterm During Resuscitation-A Prospective Observational Cohort Study. J Pediatr. 2018 Jul;198:209-213.e3. doi: 10.1016/j.jpeds.2018.02.065. Epub 2018 Apr 18. — View Citation

Katheria AC, Hassen K, Rich W, Poeltler D, Finer N. Resuscitation outcomes of infants that do not achieve a 5 min target SpO2 saturation. J Perinatol. 2019 Dec;39(12):1635-1639. doi: 10.1038/s41372-019-0491-x. Epub 2019 Sep 5. — View Citation

Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20. — View Citation

Katheria AC, Sorkhi SR, Hassen K, Faksh A, Ghorishi Z, Poeltler D. Acceptability of Bedside Resuscitation With Intact Umbilical Cord to Clinicians and Patients' Families in the United States. Front Pediatr. 2018 Apr 26;6:100. doi: 10.3389/fped.2018.00100. eCollection 2018. — View Citation

Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368. — View Citation

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Leone TA, Lange A, Rich W, Finer NN. Disposable colorimetric carbon dioxide detector use as an indicator of a patent airway during noninvasive mask ventilation. Pediatrics. 2006 Jul;118(1):e202-4. doi: 10.1542/peds.2005-2493. Epub 2006 Jun 26. — View Citation

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SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16. Erratum In: N Engl J Med. 2010 Jun 10;362(23):2235. — View Citation

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* Note: There are 59 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Changes in Inspired fractional oxygen (FiO2) Changes in Inspired fractional oxygen (FiO2) In the first 10 minutes of life
Other Duration of Hypoxia Duration of Hypoxia (defined as oxygen saturation<25th percentile of target ranges defined by Dawson et al.) in the first 10 minutes after birth The first 10 minutes of life in the delivery room
Other Duration of Hyperoxia Duration of Hyperoxia (defined as oxygen saturation>95%) in the first 10 minutes after birth The first 10 minutes of life in the delivery room
Other Changes in Mean airway pressure, MAP (cm H20) Changes in Mean airway pressure, MAP (cm H20) In the first 10 minutes of life
Other Duration of Positive Pressure Ventilation Duration of positive pressure ventilation The first 10 minutes of life in the delivery room
Other Blood pressures in the first 24 hours of life Blood pressures every hour in the first 24 hours of life In the first 24 hours of life
Other Cerebral tissue oxygenation in the first 24 hours of life Cerebral tissue oxygenation in the first 24 hours of life In the first 24 hours of life
Other Average oxygen saturation in the first 5 minutes after birth Oxygen saturation in the first 5 minutes after birth by 5 minutes of life
Other Average Heart rate in the first 5 minutes after birth Heart rate in the first 5 minutes after birth by 5 minutes of life
Other Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU) Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU) Birth through study completion at discharge, up to 6 months of corrected gestational age
Other Lowest and Highest Hemoglobin and/or Hematocrit Hemoglobin and/or Hematocrit levels (before transfusion) First 24 hours of life
Other Mean arterial blood pressure Mean arterial blood pressure (collected hourly) First 24 hours of life
Other Medication for Low Blood Pressure Medication for Low Blood Pressure (e.g. hydrocortisone or pressors) First 24 hours of life
Other CRIB-II (Clinical Risk Index for Babies) CRIB-II (Clinical Risk Index for Babies) First 12 hours of life
Other Duration of mechanical ventilation and/or CPAP Number of days on mechanical ventilation and/or CPAP Birth through study completion at discharge, up to 6 months of corrected gestational age
Other Surfactant administration Surfactant administration Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
Other Number of RBC Transfusions since birth Number of RBC Transfusions since birth First 10 days after birth
Other Patent Ductus Arteriosus requiring pharmacological or surgical treatment Patent Ductus Arteriosus requiring pharmacological or surgical treatment Through study completion at discharge, up to 6 months of corrected gestational age
Other Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain Through study completion at discharge, up to 6 months of corrected gestational age
Other Necrotizing Enterocolitis (Modified Bell's stage 2-3) Necrotizing Enterocolitis (Modified Bell's stage 2-3) Through study completion at discharge, up to 6 months of corrected gestational age
Other Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/ Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/ Hospital course until 36 weeks PMA
Other Severe ROP (stage 3 or treated with laser or bevacizumab) Severe ROP (stage 3 or treated with laser or bevacizumab) After the intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
Other Combined outcome of severe IVH and/or death Combined outcome of severe IVH and/or death Through study completion at death or discharge, up to 6 months of corrected gestational age
Other Death Death Through study completion at death or discharge, up to 6 months of corrected gestational age
Other SVC Flow Superior Vena Cava flow by echocardiography 6 hours of life
Other RVO Right Ventricular output by echocardiography 6 hours of life
Other Left Ventricular Output Left Ventricular output by echocardiography 6 hours of life
Other Cognitive Composite Score Composite Score (cognitive 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition 24 months corrected age
Other Language Composite Score Composite Score (language 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition 24 months corrected age
Other Motor Composite Score Composite Score (motor 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition 24 months corrected age
Other Cerebral Palsy As assessed by Gross Motor Function Classification System (GMFCS) Levels 1-5 24 months corrected age
Other Neurodevelopmental Outcome at 2 Years of Age Overall and Domain Scores- Ages and Stages, 3rd ed. Questionnaire 22-26 months corrected age
Other Pulsatility Index Pulsatility index calculated from Doppler of the Middle Cerebral Artery 6 hours of life
Other Resistive Index Resistive index calculated from Doppler of the Middle Cerebral Artery 6 hours of life
Other Changes in cerebral oxygenation saturation, StO2 (%) Changes in cerebral oxygenation saturation, StO2 (%) In the first 10 minutes of life
Other Changes in SpO2 (%) in the first 10 minutes of life Changes in SpO2 (%) in the first 10 minutes of life In the first 10 minutes of life
Other Inhaled Nitric Oxide Use of Inhaled Nitric Oxide for Respiratory failure or Pulmonary Hypertension Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
Other Glutathione (GSH/GSSG ratio) Assessment of oxidative biomarkers from birth up to 2 hours of life from birth up to NICU admission or in the first 2 hours of life
Other Thermoregulation Assessment of thermoregulation (axillary temperatures measured in degrees Celsius) during delayed cord clamping on extremely low gestational infants from 5 minutes of life up to NICU admission in the first 2 hours of life
Other Rate of Early Onset Sepsis assessment of early onset sepsis with a positive blood or CSF culture at From birth up to 72 hours of life
Other Rate of Late Onset Sepsis assessment of late onset sepsis with a positive blood or CSF culture at > 72 HOL From > 72 hours of life through study completion at death or discharge, up to 6 months of corrected gestational age
Primary Feasibility of administration of oxygen during delayed cord clamping and it's impact on the incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life To assess the feasibility and compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 MOL given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group). by 5 minutes of life
Secondary All Grade IVH Any Intraventricular Hemorrhage (grades 1-4) Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)
Secondary Frequency of Grade III and IV intraventricular hemorrhage Intraventricular hemorrhages (grades 3-4) (bleeding in the brain parenchyma and/or ventricular dilation Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)
Secondary Resuscitation interventions Resuscitation interventions including intubation, chest compressions, medications In the first 10 minutes of life
Secondary Changes in heart rate (BPM) in the first 10 minutes of life Changes in heart rate (BPM) in the first 10 minutes of life In the first 10 minutes of life
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