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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HD072906-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.
Hypotheses:
The SAIL trial aims to provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns (ELGAN) <1000 g birthweight (BW), but especially for those born between 23-26 weeks' gestational age (GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and childhood.
The SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR) intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current standard accepted Newborn Resuscitation Program (NRP) Guidelines. This protocol proposes a fully informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for mechanical ventilation in the first week of life which would also impact mortality rates and the incidence and severity of BPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm-Standard of care | Active Comparator | Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention |
|
| Sustained Intervention | Experimental | Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained Inflation | Procedure | The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Outcome of Death or Bronchopulmonary Dysplasia | To determine in infants born at 23-26 weeks gestational age requiring respiratory support at birth, which of two treatment strategies when compared, results in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia. | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Profile Over First 24 Hours | Oxygen profile over first 24 hours post delivery room using hourly FiO2 records | First 24 hours post delivery |
| Oxygen Profile With Highest FiO2 Level up to 48 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haresh Kirpalani, BM, MSc | Children's Hospital of Philadelphia | Principal Investigator |
| Peter Davis, MD, FRAXP | Royal Women's Hospital, Melbourne, Australia | Principal Investigator |
| Helmut Hummler, MD | Children's Hospital, University of Ulm, Ulm Germany | Principal Investigator |
| Martin Keszler, MD | Women & Infants Hospital of Rhode Island, Providence, RI | Principal Investigator |
| GianLuca Lista, MD | Ospedale dei Bambini, Milan Italy | Principal Investigator |
| Arjan te_Pas, MD | Leiden University Medical Center, Leiden, Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States | ||
| University of California, Davis Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40816312 | Derived | Owen LS, Foglia EE, Ratcliffe SJ, Simma B, Katheria AC, Te Pas A, Onland W, van Kaam AH, Keszler M, Kirpalani H, Davis PG. Alternative consent processes in a neonatal resuscitation trial (SAIL): secondary analysis of an open-label, international, multicentre, randomised trial. Lancet Child Adolesc Health. 2025 Oct;9(10):698-706. doi: 10.1016/S2352-4642(25)00185-3. Epub 2025 Aug 12. | |
| 34453917 | Derived | Foglia EE, Kirpalani H, Ratcliffe SJ, Davis PG, Thio M, Hummler H, Lista G, Cavigioli F, Schmolzer GM, Keszler M, Te Pas AB. Sustained Inflation Versus Intermittent Positive Pressure Ventilation for Preterm Infants at Birth: Respiratory Function and Vital Sign Measurements. J Pediatr. 2021 Dec;239:150-154.e1. doi: 10.1016/j.jpeds.2021.08.038. Epub 2021 Aug 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm-Standard of Care | Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2017 | Dec 10, 2019 |
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| Standard of Care | Procedure | Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention |
|
Highest FiO2 level recorded during the first 48 hours post DR
| 48 hours of life |
| Heart Rate in the Delivery Room (DR) | Categorical variable with 3 levels: <60, 60-100, >100 | First 30 seconds of life in DR |
| Detailed Status on Departure From the Delivery Room (DR) | Type of respiratory support (CPAP, PPV) and Fraction of Inspired Oxygen (FiO2) on departure from DR | Resuscitation time will vary - 1 to 30 minutes |
| Use of Inotropes on Arrival in NICU | Circulatory support post-delivery room | First 48 hours of life |
| Need for Intubation in Delivery Room | Need for intubation in delivery room during the first 30 seconds to 24 hours of age | First 30 seconds to 24 hours of life |
| Pressure-volume Characteristics in the Delivery Room (DR) | Pressure-volume characteristics in the Delivery room (DR) expected within 30 minutes | Expected average 30 minutes |
| Pneumothorax or New Chest Drains in the First 48 Hours of Life | Chest x-ray reports showing pneumothorax or new chest drains in the first 48 hours of life | First 48 hours of life |
| Duration of Any Chest Drain In-situ Post-DR | Duration of any chest drain in-situ post-DR during hospitalization - up to 36 weeks Post Menstrual Age (PMA) | During hospitalization - up to 36 weeks Post Menstrual Age (PMA) |
| Intraventricular Hemorrhage by All Grades | Head ultrasound and/or MRI findings of intraventricular hemorrhage by all grades focusing on grades 3 and 4 by 48 hour and by day 10 | 48 hours to 10 days |
| Chest X-ray Between Days 7-10 | Chest x-ray between the first 7-10 days of life | First 7-10 days of life |
| Death or Need for Positive Pressure Ventilation | Death or need for positive pressure ventilation during the first 7 days of life | First 7 days of life |
| Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life | Highest FiO2 and Area under the FiO2 curve during the first 7 days of life | First 7 days of life |
| Pneumothorax and Pulmonary Interstitial Emphysema (PIE) | Pneumothorax and pulmonary interstitial emphysema (PIE) during the first 10 days of life | First 10 days of life |
| Survival to Discharge Home Without BPD, Retinopathy of Prematurity (Grades 3 & 4), or Significant Brain Abnormalities on Head Ultrasound | Survival to discharge home without BPD, retinopathy of prematurity (grades 3 & 4), or significant brain abnormalities on head ultrasound with an expected discharge between 36-40 weeks PMA | Expected discharge between 36 - 40 weeks PMA |
| Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen) | Duration of respiratory support (ventilation, CPAP, supplemental oxygen) during hospitalization upto 36 weeks Post Menstrual Age (PMA) | During hospitalization - up to 36 weeks Post Menstrual Age (PMA) |
| Death in Hospital | Death in hospital during expected hospitalization of 23-40 weeks PMA | During expected hospitalization 23 - 40 weeks PMA |
| Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment | Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment at 36 weeks | 36 weeks |
| Use of Postnatal Steroids for Treatment of BPD | Use of postnatal steroids for treatment of BPD during hospitalization up to 36 weeks Post Menstrual Age (PMA) | During hospitalization - up to 36 weeks Post Menstrual Age (PMA) |
| Length of Hospital Stay | Length of hospital stay with average discharge between 36-40 weeks PMA | Average discharge between 36 - 40 weeks PMA |
| Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age | Neurodevelopmental and respiratory outcome at 22-26 months corrected gestational age | 22-26 months corrected gestational age |
| Sacramento |
| California |
| 95817 |
| United States |
| Sharp Mary Birch Hospital for Women & Newborns | San Diego | California | 92123 | United States |
| Christiana Care | Newark | Delaware | 19713 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Wake Med Health | Raleigh | North Carolina | 27610 | United States |
| Hospital of the Univerity of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| Mater Mother's Hospital | Brisbane | Queensland | QLD 4101 | Australia |
| Royal Women's Hospital | Melbourne | Australia |
| Academic Teaching Hospital, Landeskrankenhaus Feldkirch | Feldkirch | Austria |
| Royal Alexandra Hospital, | Edmonton | Canada |
| University of Freiburg | Freiburg im Breisgau | Germany |
| Children's Hospital, University of Ulm | Ulm | Germany |
| Ospedale dei Bambini | Milan | Italy |
| Emma Children's Hospital, AMC | Amsterdam | Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| KK Women's and Children's Hospital | Singapore | 168753 | Singapore |
| Seoul National University Children's Hospit | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| 31828052 | Derived | Kirpalani H, Keszler M, Foglia EE, Davis P, Ratcliffe S. Considering the Validity of the SAIL Trial-A Navel Gazers Guide to the SAIL Trial. Front Pediatr. 2019 Nov 27;7:495. doi: 10.3389/fped.2019.00495. eCollection 2019. |
| 30912836 | Derived | Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, Te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmolzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V, Poulain FR, Donn SM, Kim HS, Park WS, Cadet C, Kong JY, Smith A, Guillen U, Liley HG, Hopper AO, Tamura M; SAIL Site Investigators. Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1165-1175. doi: 10.1001/jama.2019.1660. |
| 27837749 | Derived | Foglia EE, Te Pas AB. Sustained Lung Inflation: Physiology and Practice. Clin Perinatol. 2016 Dec;43(4):633-646. doi: 10.1016/j.clp.2016.07.002. |
| 25872563 | Derived | Foglia EE, Owen LS, Thio M, Ratcliffe SJ, Lista G, Te Pas A, Hummler H, Nadkarni V, Ades A, Posencheg M, Keszler M, Davis P, Kirpalani H. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:95. doi: 10.1186/s13063-015-0601-9. |
| FG001 | Sustained Intervention | Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds |
| COMPLETED | These infants have completed their 36 week PMA primary outcome |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm-Standard of Care | Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention |
| BG001 | Sustained Intervention | Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Infants were included in the study based on their gestational age. - include GA strata | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | The sex of the infants are included below. | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Maternal race/ethnicity is listed below | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||
| Consent Type | Number | participants |
| |||||||||||||||||||
| Maternal Age | Median | Inter-Quartile Range | years |
|
| 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 | Combined Outcome of Death or Bronchopulmonary Dysplasia | To determine in infants born at 23-26 weeks gestational age requiring respiratory support at birth, which of two treatment strategies when compared, results in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia. | Posted | Count of Participants | Participants | 36 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Oxygen Profile Over First 24 Hours | Oxygen profile over first 24 hours post delivery room using hourly FiO2 records | Not Posted | First 24 hours post delivery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Oxygen Profile With Highest FiO2 Level up to 48 Hours | Highest FiO2 level recorded during the first 48 hours post DR | Not Posted | 48 hours of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Heart Rate in the Delivery Room (DR) | Categorical variable with 3 levels: <60, 60-100, >100 | Not Posted | First 30 seconds of life in DR | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Detailed Status on Departure From the Delivery Room (DR) | Type of respiratory support (CPAP, PPV) and Fraction of Inspired Oxygen (FiO2) on departure from DR | Not Posted | Resuscitation time will vary - 1 to 30 minutes | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Use of Inotropes on Arrival in NICU | Circulatory support post-delivery room | Not Posted | First 48 hours of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Need for Intubation in Delivery Room | Need for intubation in delivery room during the first 30 seconds to 24 hours of age | Not Posted | First 30 seconds to 24 hours of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Pressure-volume Characteristics in the Delivery Room (DR) | Pressure-volume characteristics in the Delivery room (DR) expected within 30 minutes | Not Posted | Expected average 30 minutes | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Pneumothorax or New Chest Drains in the First 48 Hours of Life | Chest x-ray reports showing pneumothorax or new chest drains in the first 48 hours of life | Not Posted | First 48 hours of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Any Chest Drain In-situ Post-DR | Duration of any chest drain in-situ post-DR during hospitalization - up to 36 weeks Post Menstrual Age (PMA) | Not Posted | During hospitalization - up to 36 weeks Post Menstrual Age (PMA) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Intraventricular Hemorrhage by All Grades | Head ultrasound and/or MRI findings of intraventricular hemorrhage by all grades focusing on grades 3 and 4 by 48 hour and by day 10 | Not Posted | 48 hours to 10 days | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Chest X-ray Between Days 7-10 | Chest x-ray between the first 7-10 days of life | Not Posted | First 7-10 days of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Death or Need for Positive Pressure Ventilation | Death or need for positive pressure ventilation during the first 7 days of life | Not Posted | First 7 days of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life | Highest FiO2 and Area under the FiO2 curve during the first 7 days of life | Not Posted | First 7 days of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Pneumothorax and Pulmonary Interstitial Emphysema (PIE) | Pneumothorax and pulmonary interstitial emphysema (PIE) during the first 10 days of life | Not Posted | First 10 days of life | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Survival to Discharge Home Without BPD, Retinopathy of Prematurity (Grades 3 & 4), or Significant Brain Abnormalities on Head Ultrasound | Survival to discharge home without BPD, retinopathy of prematurity (grades 3 & 4), or significant brain abnormalities on head ultrasound with an expected discharge between 36-40 weeks PMA | Not Posted | Expected discharge between 36 - 40 weeks PMA | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen) | Duration of respiratory support (ventilation, CPAP, supplemental oxygen) during hospitalization upto 36 weeks Post Menstrual Age (PMA) | Not Posted | During hospitalization - up to 36 weeks Post Menstrual Age (PMA) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Death in Hospital | Death in hospital during expected hospitalization of 23-40 weeks PMA | Not Posted | During expected hospitalization 23 - 40 weeks PMA | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment | Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment at 36 weeks | Not Posted | 36 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Use of Postnatal Steroids for Treatment of BPD | Use of postnatal steroids for treatment of BPD during hospitalization up to 36 weeks Post Menstrual Age (PMA) | Not Posted | During hospitalization - up to 36 weeks Post Menstrual Age (PMA) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay | Length of hospital stay with average discharge between 36-40 weeks PMA | Not Posted | Average discharge between 36 - 40 weeks PMA | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age | Neurodevelopmental and respiratory outcome at 22-26 months corrected gestational age | Not Posted | 22-26 months corrected gestational age | Participants |
Adverse events were collected from birth to discharge, death or 44 weeks PMA whichever occurred first
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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 | Control Arm-Standard of Care | Control Arm-Respiratory support using Standard of Care positive-end expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O compared to Sustained Inflation intervention Standard of Care: Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention | 35 | 211 | 51 | 211 | 146 | 211 |
| EG001 | Sustained Intervention | Administer delivery room respiratory support using a Sustained Inflation (SI) intervention and expiratory pressure/continuous positive airway pressure (PEEP/CPAP) of 5-7 cm H2O Sustained Inflation: The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds | 48 | 215 | 45 | 215 | 157 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Within the first 48 hours post delivery |
| |
| Administration of epinephrine or chest compressions | Surgical and medical procedures | Non-systematic Assessment | Within the first 48 hours post delivery |
| |
| Pneumothorax | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Within the first 10 days of life |
| |
| Pulmonary Interstitial Emphysemia (PIE) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Within the first 10 days of life |
| |
| Grade 3 or 4 IVH | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Within the first 10 days of life |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FiO2>=0.4 for >=2 hrs in first 2 DOL | Surgical and medical procedures | Non-systematic Assessment |
| ||
| IVH Grade 1/2 within first 10 days of life | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| >30% oxygen at 28 days of life | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Mechanical support at 28 days of life | Surgical and medical procedures | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haresh Kirpalani | Children's Hospital of Philadelphia (CHOP) | 215-590-2455 | kirpalanih@email.chop.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2014 | May 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
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| Title | Measurements |
|---|---|
|
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| Netherlands |
|
| Austria |
|
| South Korea |
|
| Singapore |
|
| United States |
|
| Italy |
|
| Australia |
|
| Germany |
|
| Deferred |
|