Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants (DOXIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413097
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : March 25, 2022
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sharp Mary Birch Hospital for Women & Newborns
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

Brief 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).

Condition or disease Intervention/treatment Phase
IVH- Intraventricular Hemorrhage Extreme Prematurity Hypoxia Neonatal Hyperoxia Respiratory Insufficiency Procedure: Delayed Cord Clamping with Low Oxygen concentration Procedure: Delayed Cord Clamping with High Oxygen concentration Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Once consent is obtained and the research staff is notified of a subject's impending birth, our research team member will open a randomization card and set the oxygen blender on the special bed to either an FiO2 of .30 or 1.0 and cover the blender. The research team member will not be involved in the clinical care for the infant and will blind the clinical care team from the randomized assignment.
Primary Purpose: Prevention
Official Title: Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : June 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: DCC and Low Oxygen Concentration
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.
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.
Other Names:
  • DCC with Low Oxygen concentration
  • DCC LO group

Experimental: DCC and High Oxygen Concentration
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.
Procedure: 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.
Other Names:
  • DCC with High Oxygen concentration
  • DCC HI group




Primary Outcome Measures :
  1. Incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life [ Time Frame: at 5 minutes of life ]
    To 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).


Secondary Outcome Measures :
  1. All Grade IVH [ Time Frame: Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA) ]
    Any Intraventricular Hemorrhage (grades 1-4)

  2. Frequency of Grade III and IV intraventricular hemorrhage [ Time Frame: Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA) ]
    Intraventricular hemorrhages (grades 3-4) (bleeding in the brain parenchyma and/or ventricular dilation

  3. Resuscitation interventions [ Time Frame: In the first 10 minutes of life ]
    Resuscitation interventions including intubation, chest compressions, medications

  4. Changes in heart rate (BPM) in the first 10 minutes of life [ Time Frame: In the first 10 minutes of life ]
    Changes in heart rate (BPM) in the first 10 minutes of life


Other Outcome Measures:
  1. Changes in Inspired fractional oxygen (FiO2) [ Time Frame: In the first 10 minutes of life ]
    Changes in Inspired fractional oxygen (FiO2)

  2. Duration of Hypoxia [ Time Frame: The first 10 minutes of life in the delivery room ]
    Duration of Hypoxia (defined as oxygen saturation<25th percentile of target ranges defined by Dawson et al.) in the first 10 minutes after birth

  3. Duration of Hyperoxia [ Time Frame: The first 10 minutes of life in the delivery room ]
    Duration of Hyperoxia (defined as oxygen saturation>95%) in the first 10 minutes after birth

  4. Changes in Mean airway pressure, MAP (cm H20) [ Time Frame: In the first 10 minutes of life ]
    Changes in Mean airway pressure, MAP (cm H20)

  5. Duration of Positive Pressure Ventilation [ Time Frame: The first 10 minutes of life in the delivery room ]
    Duration of positive pressure ventilation

  6. Blood pressures in the first 24 hours of life [ Time Frame: In the first 24 hours of life ]
    Blood pressures every hour in the first 24 hours of life

  7. Cerebral tissue oxygenation in the first 24 hours of life [ Time Frame: In the first 24 hours of life ]
    Cerebral tissue oxygenation in the first 24 hours of life

  8. Average oxygen saturation in the first 5 minutes after birth [ Time Frame: at 5 minutes of life ]
    Oxygen saturation in the first 5 minutes after birth

  9. Average Heart rate in the first 5 minutes after birth [ Time Frame: at 5 minutes of life ]
    Heart rate in the first 5 minutes after birth

  10. Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU) [ Time Frame: Birth through study completion at discharge, up to 6 months of corrected gestational age ]
    Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU)

  11. Lowest and Highest Hemoglobin and/or Hematocrit [ Time Frame: First 24 hours of life ]
    Hemoglobin and/or Hematocrit levels (before transfusion)

  12. Mean arterial blood pressure [ Time Frame: First 24 hours of life ]
    Mean arterial blood pressure (collected hourly)

  13. Medication for Low Blood Pressure [ Time Frame: First 24 hours of life ]
    Medication for Low Blood Pressure (e.g. hydrocortisone or pressors)

  14. CRIB-II (Clinical Risk Index for Babies) [ Time Frame: First 12 hours of life ]
    CRIB-II (Clinical Risk Index for Babies)

  15. Duration of mechanical ventilation and/or CPAP [ Time Frame: Through study completion at discharge, up to 6 months of corrected gestational age ]
    Number of days on mechanical ventilation and/or CPAP

  16. Surfactant administration [ Time Frame: First 10 days after birth ]
    Surfactant administration

  17. Number of RBC Transfusions since birth [ Time Frame: First 10 days after birth ]
    Number of RBC Transfusions since birth

  18. Patent Ductus Arteriosus requiring pharmacological or surgical treatment [ Time Frame: Through study completion at discharge, up to 6 months of corrected gestational age ]
    Patent Ductus Arteriosus requiring pharmacological or surgical treatment

  19. Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain [ Time Frame: Through study completion at discharge, up to 6 months of corrected gestational age ]
    Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain

  20. Necrotizing Enterocolitis (Modified Bell's stage 2-3) [ Time Frame: Through study completion at discharge, up to 6 months of corrected gestational age ]
    Necrotizing Enterocolitis (Modified Bell's stage 2-3)

  21. 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/ [ Time Frame: Hospital course until 36 weeks PMA ]
    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/

  22. Severe ROP (stage 3 or treated with laser or bevacizumab) prior to 36 weeks PMA [ Time Frame: Hospital course until 36 weeks PMA ]
    Severe ROP (stage 3 or treated with laser or bevacizumab) prior to 36 weeks PMA

  23. Combined outcome of severe IVH and/or death [ Time Frame: Through study completion at death or discharge, up to 6 months of corrected gestational age ]
    Combined outcome of severe IVH and/or death

  24. Death [ Time Frame: Through study completion at death or discharge, up to 6 months of corrected gestational age ]
    Death

  25. SVC Flow [ Time Frame: 6 hours of life ]
    Superior Vena Cava flow by echocardiography

  26. RVO [ Time Frame: 6 hours of life ]
    Right Ventricular output by echocardiography

  27. Left Ventricular Output [ Time Frame: 6 hours of life ]
    Left Ventricular output by echocardiography

  28. Cognitive Composite Score [ Time Frame: 24 months corrected age ]
    Composite Score (cognitive 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition

  29. Language Composite Score [ Time Frame: 24 months corrected age ]
    Composite Score (language 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition

  30. Motor Composite Score [ Time Frame: 24 months corrected age ]
    Composite Score (motor 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition

  31. Cerebral Palsy [ Time Frame: 24 months corrected age ]
    As assessed by Gross Motor Function Classification System (GMFCS) Levels 1-5

  32. Pulsatility Index [ Time Frame: 6 hours of life ]
    Pulsatility index calculated from Doppler of the Middle Cerebral Artery

  33. Resistive Index [ Time Frame: 6 hours of life ]
    Resistive index calculated from Doppler of the Middle Cerebral Artery

  34. Changes in cerebral oxygenation saturation, StO2 (%) [ Time Frame: In the first 10 minutes of life ]
    Changes in cerebral oxygenation saturation, StO2 (%)

  35. Changes in SpO2 (%) in the first 10 minutes of life [ Time Frame: In the first 10 minutes of life ]
    Changes in SpO2 (%) in the first 10 minutes of life

  36. Inhaled Nitric Oxide [ Time Frame: Hospital course until 36 weeks PMA ]
    Use of Inhaled Nitric Oxide for Respiratory failure or Pulmonary Hypertension



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413097


Contacts
Layout table for location contacts
Contact: Anup Katheria, MD 858-939-4170 anup.katheria@sharp.com
Contact: Felix Ines, RCP-RRT 858-939-4136 felix.ines@sharp.com

Locations
Layout table for location information
United States, California
University of California Davis Recruiting
Davis, California, United States, 95618
Contact: Payam Vali, MD    916-734-8672    pvali@ucdavis.edu   
Sharp Mary Birch Hospital for Women and Newborns Recruiting
San Diego, California, United States, 92123
Contact: Anup C Katheria, MD    858-939-4198    anup.katheria@sharp.com   
Contact: Felix Ines, RCP-RRT    858-939-4136    felix.ines@sharp.com   
Sponsors and Collaborators
Sharp HealthCare
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sharp Mary Birch Hospital for Women & Newborns
Investigators
Layout table for investigator information
Principal Investigator: Anup Katheria, MD Sharp HealthCare
Publications:
Rabe H, Wacker A, Hulskamp G, Homig-Franz I, Jorch G. Late cord clamping benefits extrauterine adaptation. Pediatric research. 1998;44:454.
Nelle, M., Fisher, S., Conze, S. et al. EFFECTS OF LATE CORD CLAMPING ON CIRCULATION IN PREMATURES (VLBWI). Pediatric Research. 1998;44;454
Narendra, A., Beckett, C., Aitchison, T. et al. Is it Possible to Promote Placental Transfusion (PTFx) at Preterm Delivery?. Pediatric Research. 1998;44;454

Layout table for additonal information
Responsible Party: Anup Katheria, M.D., Director of Neonatal Research Institute, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT04413097    
Other Study ID Numbers: DOXIE
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available per NICHD requirements (National Institute of Child Health and Human Development)
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 2 years after primary publication
Access Criteria: An archived dataset with documentation will be made available for additional users by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
Delayed Cord Clamping
IVH- Intraventricular Hemorrhage
Hyperoxia in Neonates
Hypoxia Neonatal
Continuous Positive Airway Pressure (CPAP)
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Hemorrhage
Hypoxia
Hyperoxia
Pathologic Processes
Signs and Symptoms, Respiratory
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases