Respiratory Insufficiency Clinical Trial
— DOXIEOfficial title:
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
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 |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Sharp HealthCare | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sharp Mary Birch Hospital for Women & Newborns |
United States,
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* Note: There are 59 references in all — Click here to view all references
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 = 72 HOL | 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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