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The purpose of this study is to compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask to subjects receiving room air in those presenting for scheduled cesarean sections.
Objective:
To compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask to subjects receiving room air in those presenting for scheduled cesarean sections. The investigators hypothesize that umbilical artery pH levels will not be significantly lowered in the oxygenated group.
Primary outcome: umbilical artery pH levels in the oxygenated versus room air group
Secondary outcomes: Apgars, respiratory distress syndrome, necrotizing enterocolitis, interventricular hemorrhage, intubation, number of NICU days and neonatal mortality.
Methods:
Only term elective c-sections will be approached for study consent. Once enrolled subjects will be randomized either receive 10L/min via simple facemask or to room air. Once regional anesthesia is completed, then the facemask with oxygen will be placed. The time from oxygen administration to uterine incision will be at least 10 min. At the time of delivery umbilical cord gases will be collected by and will be processed within one hour of delivery.
Inclusion criteria:
Exclusion criteria:
Statistical analysis:
Subjects will be randomized via block randomization. The estimated umbilical arterial pH in the scheduled cesarean section room air group is 7.31. To identify a 0.05 or greater difference between the control and treatment group, a power of 0.8, alpha of 0.05 the investigators would need 64 subjects total. To account for drop out the investigators intend to enroll a total of 70 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental oxygen | Experimental | Subjects in this arm will receive 10L/min via simple facemask |
|
| Room air | No Intervention | This control arm will receive no supplemental oxygen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: simple facemask to administer supplemental oxygen | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical Cord pH Levels | marker for metabolic acidosis | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical Cord Base Excess | marker for metabolic acidosis | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
| Umbilical Cord Partial Pressure Carbon Dioxide (pCO2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Nageotte, MD | MemorialCare Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital | Long Beach | California | 90806 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supplemental Oxygen | Subjects in this arm will receive 10L/min via simple facemask Device: simple facemask to administer supplemental oxygen |
| FG001 | Room Air | This control arm will receive no supplemental oxygen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
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| ID | Title | Description |
|---|---|---|
| BG000 | Supplemental Oxygen | Subjects in this arm will receive 10L/min via simple facemask Device: simple facemask to administer supplemental oxygen |
| BG001 | Room Air | This control arm will receive no supplemental oxygen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Umbilical Cord pH Levels | marker for metabolic acidosis | Posted | Median | Inter-Quartile Range | pH | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supplemental Oxygen | Subjects in this arm will receive 10L/min via simple facemask Device: simple facemask to administer supplemental oxygen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Nageotte, MD | Memorial Health Systems | 562-933-2748 | mnageotte@memorialcare.org |
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marker for metabolic acidosis
| collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
| Umbilical Cord Bicarbonate (HCO3) | marker for metabolic acidosis | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
| Number of Newborns With an Apgar Score <7 | quick test performed on all babies once born that access how babies transition after birth. The following signs are given values of 0, 1, or 2 and added to compute the Apgar score. The higher the points the better. maximum points is 10. minimum score is 0. Signs: Color (0=blue/pale, 1=acrocyanotic, 2=completely pink), Heart rate (0=absent, 1=<100 minute, 2=>100 minute), Reflex irritability(0=no response, 1=grimace, 2=cry), muscle tone (0=limp, 1=some flexion, 2=active motion), Respiration (0=absent, 1=weak cry; hypoventilation, 2=good, crying) | completed at 5 minutes of life, Apgar <7 |
| Number of Newborns With Respiratory Distress Syndrome | syndrome typically affecting premature babies due to immature lung maturation or development | completed once infant is discharged home; anticipate 1-4 days |
| Number of Newborns With Necrotizing Enterocolitis | condition that affects newborn bowels where the tissue undergoes necrosis | completed once infant is discharged home; anticipate 1-4 days |
| Number of Newborns With Intraventricular Hemorrhage | condition that causes bleeding within the brain typically affecting premature babies | completed once infant is discharged home; anticipate 1-4 days |
| Number of Newborns Requiring Intubation | needing supplemental oxygen for the newborn through breathing device | completed once infant is discharged home; anticipate 1-4 days |
| Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit) | if newborns need higher intensity of care they are transferred to the Neonatal Intensive Care Unit. | completed once infant is discharged home; anticipate 1-4 days |
| Neonatal Mortality | completed once infant is discharged home; anticipate 1-4 days |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex/Gender, Customized | Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Umbilical Cord Base Excess | marker for metabolic acidosis | Posted | Median | Inter-Quartile Range | mEq/L | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
|
|
|
| Secondary | Umbilical Cord Partial Pressure Carbon Dioxide (pCO2) | marker for metabolic acidosis | Posted | Median | Inter-Quartile Range | mmHg | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
|
|
|
| Secondary | Umbilical Cord Bicarbonate (HCO3) | marker for metabolic acidosis | Posted | Median | Inter-Quartile Range | mEq/L | collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection |
|
|
|
| Secondary | Number of Newborns With an Apgar Score <7 | quick test performed on all babies once born that access how babies transition after birth. The following signs are given values of 0, 1, or 2 and added to compute the Apgar score. The higher the points the better. maximum points is 10. minimum score is 0. Signs: Color (0=blue/pale, 1=acrocyanotic, 2=completely pink), Heart rate (0=absent, 1=<100 minute, 2=>100 minute), Reflex irritability(0=no response, 1=grimace, 2=cry), muscle tone (0=limp, 1=some flexion, 2=active motion), Respiration (0=absent, 1=weak cry; hypoventilation, 2=good, crying) | Posted | Number | newborns | completed at 5 minutes of life, Apgar <7 |
|
|
|
| Secondary | Number of Newborns With Respiratory Distress Syndrome | syndrome typically affecting premature babies due to immature lung maturation or development | Posted | Count of Participants | Participants | completed once infant is discharged home; anticipate 1-4 days |
|
|
|
| Secondary | Number of Newborns With Necrotizing Enterocolitis | condition that affects newborn bowels where the tissue undergoes necrosis | Posted | Count of Participants | Participants | completed once infant is discharged home; anticipate 1-4 days |
|
|
|
| Secondary | Number of Newborns With Intraventricular Hemorrhage | condition that causes bleeding within the brain typically affecting premature babies | Posted | Count of Participants | Participants | completed once infant is discharged home; anticipate 1-4 days |
|
|
|
| Secondary | Number of Newborns Requiring Intubation | needing supplemental oxygen for the newborn through breathing device | Posted | Count of Participants | Participants | completed once infant is discharged home; anticipate 1-4 days |
|
|
|
| Secondary | Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit) | if newborns need higher intensity of care they are transferred to the Neonatal Intensive Care Unit. | Posted | Count of Participants | Participants | completed once infant is discharged home; anticipate 1-4 days |
|
|
|
| Secondary | Neonatal Mortality | Posted | Count of Participants | Participants | completed once infant is discharged home; anticipate 1-4 days |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Room Air | This control arm will receive no supplemental oxygen | 0 | 35 | 0 | 35 |
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