Trial · NCT03631940
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Birth to first 48 hours of life. | 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. |
| Secondary | Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | 12-48 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. |
| Secondary | Number of Neonates Treated With Therapeutic Hypothermia ("Cooling") | Birth to 78 hours of life. | 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. |
| Secondary | Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life | Birth through 24 hours of life | Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure. |
| Secondary | Median Peak Total Serum Bilirubin in Neonates | First week of life | Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate. |
| Secondary | Median Transcutaneous Bilirubin in Neonates | birth to 7 days of life | Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate. |
| Secondary | Number of Neonatal Deaths | Birth to discharge, assessed up to 180 days of life. | Number of neonatal deaths prior to discharge |
| Other | Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy | Birth to discharge, up to 120 days of life. | Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission. |
| Other | Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive | birth to discharge, up to 120 days of life. | Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home. |
| Other | Median Neonatal Admission Blood Pressure | Birth to 48 hours of life. | 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. |
| Other | Number of Neonates With Any Cardiorespiratory Support Intervention at Birth | Birth to first hour of life. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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