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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD096023-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Sharp Mary Birch Hospital for Women & Newborns | OTHER |
| Sharp Grossmont Hospital | OTHER |
| University of Utah | OTHER |
| University of Alberta |
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The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.
At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems.
The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Milking | Experimental | The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials. |
|
| Early Cord Clamping | Active Comparator | This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Milking | Procedure | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission. | Birth to first 48 hours of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care. | 12-48 hours of life |
| Number of Neonates Treated With Therapeutic Hypothermia ("Cooling") |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy | Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission. | Birth to discharge, up to 120 days of life. |
| Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup Katheria, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States | ||
| Loma Linda Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38949814 | Derived | Katheria AC, El Ghormli L, Clark E, Yoder B, Schmolzer GM, Law BHY, El-Naggar W, Rittenberg D, Sheth S, Martin C, Vora F, Lakshminrusimha S, Underwood M, Mazela J, Kaempf J, Tomlinson M, Gollin Y, Rich W, Morales A, Varner M, Poeltler D, Vaucher Y, Mercer J, Finer N, Rice MM. Two-Year Outcomes of Umbilical Cord Milking in Nonvigorous Infants: A Secondary Analysis of the MINVI Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2416870. doi: 10.1001/jamanetworkopen.2024.16870. |
| Label | URL |
|---|---|
| MINVI NIRS Substudy | View source |
Not provided
Prior to the initiation of recruitment each participating hospital was assigned to perform umbilical cord milking or early cord clamping on non-vigorous neonates-mother dyads delivered during the recruitment period.
Prior to the start of recruitment in the crossover study period (Study Period 2) a 1-2-month washout period was specified by the protocol for the purpose of site hospital staff retraining and to assess adherence to the new assigned intervention.
10 sites were randomized to perform umbilical cord milking or early cord clamping for eligible neonate-mother dyads. Research staff at each sites approached eligible neonate-mother dyads after delivery for written informed consent for additional data collection. Hospital recruited neonate-mother dyads in the initial period from January 2019 to January 2020 and from February 2020 and May 2021 for the crossover period. Neonate-mother dyads participated in a single period of the study.
| ID | Title | Description |
|---|---|---|
| FG000 | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | Umbilical Cord Milking performed in the initial phase and Early Cord Clamping performed in the crossover phase. |
| FG001 | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad | Early Cord Clamping was performed in the initial phase and Umbilical Cord Milking in the crossover phase |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Randomized Intervention Period 1 |
| |||||||||||||
| Crossover Intervention Period 2 |
|
Baseline data was collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. Maternal sex and region of enrollment were not collected.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Umbilical Cord Milking - Neonate | All neonates who received umbilical cord milking intervention at the time of birth. Umbilical Cord Milking: At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. |
| BG001 | Early Cord Clamping - Neonate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Infant gestational age at birth reported in weeks. |
| 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 | Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission. | Neonates with admission disposition status | Posted | Count of Participants | Participants | Birth to first 48 hours of life. |
|
Neonate's birth to discharge home up to 180 days
Adverse events were assessed for neonates only and were collected from delivery to discharge home.
Adverse events occurring after discharge were collected as part of follow-up sub-study and will be reported with developmental outcome results is separate publication.
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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 | Umbilical Cord Milking-Neonates | All neonates who received umbilical cord milking intervention at the time of birth. Umbilical Cord Milking: At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonates with intraventricular hemorrhage grade 3 or 4 as assessed by head ultrasound or MRI | Nervous system disorders | Systematic Assessment | Evaluated in neonates admitted to the neonatal intensive care unit and assessed from birth to discharge home, up to 120 days of life. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonates with intraventricular hemorrhage grade 1 | Nervous system disorders | Systematic Assessment | Number of neonates diagnosed with intraventricular hemorrhage grade 1. Assessed from birth to discharge home, up to 120 days of life. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anup Katheria | Sharp Healthcare | 8589394170 | Anup.Katheria@sharp.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 | May 30, 2024 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| OTHER |
| Poznan University of Medical Sciences | OTHER |
| IWK Health Centre | OTHER |
| University of California, Davis | OTHER |
| Loma Linda University | OTHER |
| George Washington University | OTHER |
| Providence Hospital | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Cluster Randomized Crossover
Not provided
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Not provided
| Early Cord Clamping | Procedure | The umbilical cord is clamped within 60 seconds of delivery. |
|
Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life. |
| Birth to 78 hours of life. |
| Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life | Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure. | Birth through 24 hours of life |
| Median Peak Total Serum Bilirubin in Neonates | Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate. | First week of life |
| Median Transcutaneous Bilirubin in Neonates | Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate. | birth to 7 days of life |
| Number of Neonatal Deaths | Number of neonatal deaths prior to discharge | Birth to discharge, assessed up to 180 days of life. |
Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home. |
| birth to discharge, up to 120 days of life. |
| Median Neonatal Admission Blood Pressure | First single neonatal blood pressure measurement by cuff or arterial line obtained on admission to the neonatal intensive care unit and by 48 hours of life. | Birth to 48 hours of life. |
| Number of Neonates With Any Cardiorespiratory Support Intervention at Birth | Neonates were assessed for poor tone, poor color (pale, dusky, cyanotic) and poor breathing effort by obstetric provider as part of standard care. Resuscitation assessment and interventions were conducted by neonatal intensive care clinical team. Recorded resuscitation interventions included: use of supplemental oxygen, continuous positive airway pressure respiratory support, positive pressure ventilation respiratory support, endotracheal intubation, chest compressions, epinephrine, normal saline bolus and other cardiorespiratory support medications. Resuscitation interventions including cardiorespiratory support were determined by individual site's clinical standards. | Birth to first hour of life. |
| Loma Linda |
| California |
| 92350 |
| United States |
| Sharp Grossmont Hospital | San Diego | California | 91942 | United States |
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225-6603 | United States |
| University of Utah/IMH | Salt Lake City | Utah | 84113 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada |
| Dalhousie University | Dalhousie | New Brunswick | E8C 2R6 | Canada |
| Poznan University of Medical Science | Poznan | Poland |
| MINVI Follow-up study | View source |
| MINVI Echocardiogram Substudy | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
All neonates who received early cord clamping at the time of birth. Early Cord Clamping: The umbilical cord is clamped as soon as possible and within 60 seconds of delivery. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| weeks |
|
| Age, Continuous | Maternal age at the time of delivery reported in years | Baseline data including maternal age was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Infant sex: Female, Males | Baseline data including neonatal sex was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. Maternal sex was not collected. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Neonatal ethnicity as reported by birth parent. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Neonatal race as reported by birth parent. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Self-reported maternal race and ethnicity. | Count of Participants | Participants |
|
| Region of Enrollment | Region of enrollment determined based on neonate's birth hospital location. | Number | neonate participants |
|
| Maternal age | Median | Inter-Quartile Range | years |
|
| Maternal level of education: some college education | Self-reported maternal level of education of at least some college education or higher degree. | Baseline data including level of education was only collected from participants who provided written consent for additional data collection. Disclosure of level of education was voluntary and not disclosed by all participants. | Count of Participants | Participants |
|
| Maternal hypertension | Number of neonates delivered by a mother who experienced hypertension during pregnancy. | Baseline data including maternal hypertension status was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Count of Participants | Participants |
|
| Maternal diabetes | Number of neonates delivered by a mother with diabetes during pregnancy. | Baseline data including maternal diabetes status was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Count of Participants | Participants |
|
| Maternal intrauterine inflammation or infection | Number of neonates delivered by a mother diagnosed with intrauterine inflammation or intrauterine infection. | Baseline data including maternal intrauterine inflammation or infection status was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Count of Participants | Participants |
|
| Maternal group B streptococcus infection | Number of neonates delivered by a mother with a positive group B streptococcus culture. | Baseline data including maternal group B streptococcus infection status was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Count of Participants | Participants |
|
| Number of hours membranes were ruptured before delivery of neonate | Baseline data including length of rupture of membranes was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Median | Inter-Quartile Range | hours |
|
| Maternal general anesthesia | Number of neonates delivered by a mother who was administered general anesthesia at the time of delivery. | Baseline data including general anesthesia was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Count of Participants | Participants |
|
| Multiple gestation birth | Number of neonates delivered by a mother with a multiple gestation pregnancy | Baseline data including multiple gestation status was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Count of Participants | Participants |
|
| Maternal narcotic or central nervous system depressant medication ≤ 2 hours before delivery | Number of neonates delivered by a mother who was administered an intravenous/oral narcotic or central nervous system depressant medication within 2 hours before delivery. | Count of Participants | Participants |
|
| Mode of delivery | Method used to deliver neonate. | Count of Participants | Participants |
|
| Neonatal birth weight | Baseline data including neonatal birthweight was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval. | Median | Inter-Quartile Range | grams |
|
| OG001 |
| Early Cord Clamping - Neonate |
Early Cord Clamping: The umbilical cord is clamped as soon as possible and within 60 seconds of delivery. |
|
|
|
| Secondary | Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care. | Neonates with a hemoglobin measurement obtained between 12 to 48 hours of life either by standard or care of with parental consent. | Posted | Median | Inter-Quartile Range | g/dL | 12-48 hours of life |
|
|
|
| Secondary | Number of Neonates Treated With Therapeutic Hypothermia ("Cooling") | Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life. | Neonates with admission disposition status | Posted | Count of Participants | Participants | Birth to 78 hours of life. |
|
|
|
| Secondary | Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life | Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure. | Neonates with admission disposition status | Posted | Count of Participants | Participants | Birth through 24 hours of life |
|
|
|
| Secondary | Median Peak Total Serum Bilirubin in Neonates | Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate. | All neonates with a total serum bilirubin result from a blood test obtained as part of standard care. | Posted | Median | Inter-Quartile Range | mg/dL | First week of life |
|
|
|
| Secondary | Median Transcutaneous Bilirubin in Neonates | Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate. | All neonates with a transcutaneous bilirubin measurement in the first week of life as part of standard care. | Posted | Median | Inter-Quartile Range | mg/dL | birth to 7 days of life |
|
|
|
| Secondary | Number of Neonatal Deaths | Number of neonatal deaths prior to discharge | Neonates with discharge status available | Posted | Count of Participants | Participants | Birth to discharge, assessed up to 180 days of life. |
|
|
|
| Other Pre-specified | Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy | Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission. | Neonates with admission disposition status | Posted | Count of Participants | Participants | Birth to discharge, up to 120 days of life. |
|
|
|
| Other Pre-specified | Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive | Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home. | Neonates with discharge status | Posted | Median | Inter-Quartile Range | days | birth to discharge, up to 120 days of life. |
|
|
|
| Other Pre-specified | Median Neonatal Admission Blood Pressure | First single neonatal blood pressure measurement by cuff or arterial line obtained on admission to the neonatal intensive care unit and by 48 hours of life. | Neonates admitted to the neonatal intensive care unit with a blood pressure measurement in the first 48 hours of life. | Posted | Median | Inter-Quartile Range | mm Hg | Birth to 48 hours of life. |
|
|
|
| Other Pre-specified | Number of Neonates With Any Cardiorespiratory Support Intervention at Birth | Neonates were assessed for poor tone, poor color (pale, dusky, cyanotic) and poor breathing effort by obstetric provider as part of standard care. Resuscitation assessment and interventions were conducted by neonatal intensive care clinical team. Recorded resuscitation interventions included: use of supplemental oxygen, continuous positive airway pressure respiratory support, positive pressure ventilation respiratory support, endotracheal intubation, chest compressions, epinephrine, normal saline bolus and other cardiorespiratory support medications. Resuscitation interventions including cardiorespiratory support were determined by individual site's clinical standards. | Neonates with resuscitation intervention data collected at the time of birth. | Posted | Count of Participants | Participants | Birth to first hour of life. |
|
|
|
| 0 |
| 872 |
| 1 |
| 872 |
| 4 |
| 872 |
| EG001 | Early Cord Clamping-Neonates | All neonates who received early cord clamping at the time of birth. Early Cord Clamping: The umbilical cord is clamped as soon as possible and within 60 seconds of delivery. | 4 | 858 | 2 | 858 | 2 | 858 |
|
| Neonates with polycythemia | Blood and lymphatic system disorders | Systematic Assessment | Single hematocrit measurement greater than 65% in the neonate's first week of life and assessed from birth to discharge home, up to 120 days of life. |
|
| Neonates with pulmonary hemorrhage | Vascular disorders | Systematic Assessment | Evaluated in neonates admitted to the neonatal intensive care unit and assessed from birth to discharge home, up to 120 days of life. |
|
| Neonates with hyperbilirubinemia requiring an exchange transfusion | Blood and lymphatic system disorders | Systematic Assessment | Evaluated in neonates admitted to the neonatal intensive care unit and assessed from birth to discharge home, up to 120 days of life. |
|
|
| Neonates with intraventricular hemorrhage grade 2 | Nervous system disorders | Systematic Assessment | Number of neonates diagnosed with intraventricular hemorrhage grade 2. Assessed from birth to discharge home, up to 120 days of life. |
|
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown |
|
| Neonates with a diagnosis of severe hypoxic ischemic encephalopathy |
|
| Neonates with no hypoxic ischemic encephalopathy diagnosis |
|
| Number of neonates who received positive pressure ventilation support in the delivery room |
|
| Number of neonates who received endotracheal intubation in the delivery room |
|
| Number of neonates who received chest compressions in the delivery room |
|
| Number of neonates administered epinephrine, fluid bolus or other medication in the delivery room |
|
| Number of neonates with no cardiorespiratory support in the delivery room |
|