Inhaled Nitric Oxide (INO) for the Prevention of Bronchop... | NCT00931632

NCT00931632

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Inhaled Nitric Oxide	Experimental	Inhaled Nitric Oxide	Drug: Inhaled Nitric Oxide
Placebo	Placebo Comparator	Nitrogen Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhaled Nitric Oxide	Drug	Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.

Outcomes Module

Measure	Description	Time Frame
Survival Without BPD at 36 Weeks		Baseline, 36 weeks PMA

Secondary Outcomes

Measure	Description	Time Frame
Days of Airway Pressure Support - Intent-to-treat Population	Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.	Through hospital discharge, an average of 105 days for placebo and 108 days for INO

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
James Baldassarre, MD	Mallinckrodt	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Children's Hospital		Phoenix	Arizona	85006	United States
St. Joseph's Hospital and Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28973344	Result	Hasan SU, Potenziano J, Konduri GG, Perez JA, Van Meurs KP, Walker MW, Yoder BA; Newborns Treated With Nitric Oxide (NEWNO) Trial Group. Effect of Inhaled Nitric Oxide on Survival Without Bronchopulmonary Dysplasia in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Nov 1;171(11):1081-1089. doi: 10.1001/jamapediatrics.2017.2618.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Inhaled Nitric Oxide

FG000229 subjectsRandomized

FG001222 subjectsRandomized

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
BG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Preterm infants < 30 weeks Gestational Age (GA)

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG000229 BG001222 BG002451

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000114 BG001106 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG000120 BG00185 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000209 BG001203 BG002

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

Survival Without BPD at 36 Weeks

Subjects with missing primary outcome or who crossed over to open-label iNO during the blinded treatment period were considered as failures

Posted

Number

participants

Baseline, 36 weeks PMA

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000229 OG001222

Title

Denominators

Categories

Alive without BPD at 36 weeks GA

Title	Measurements
	OG00080 OG00170

Death or had BPD at 36 weeks GA

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mantel Haenszel		0.427						2-Sided								Superiority or Other

Secondary

Days of Airway Pressure Support - Intent-to-treat Population

Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.

Posted

Mean

Standard Deviation

Days

Through hospital discharge, an average of 105 days for placebo and 108 days for INO

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000

Secondary

Length of Birth Hospitalization

Number of subjects within the Intent-to-treat population with available data

Posted

Mean

Standard Deviation

Days

Through hospital discharge, an average of 105 days for placebo and 108 days for INO

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000

Secondary

Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia

Intent-to-treat population

Posted

Count of Participants

Participants

Through hospital discharge, an average of 105 days for placebo and 108 days for INO

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000

Secondary

Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason

Intent-to-treat population

Posted

Count of Participants

Participants

Through hospital discharge, an average of 105 days for placebo and 108 days for INO

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000

Secondary

Systemic Use of Postnatal Corticosteroids for Any Medical Reason

Intent-to-treat population

Posted

Count of Participants

Participants

Through hospital discharge, an average of 105 days for placebo and 108 days for INO

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000

Secondary

Number of Days of Oxygen Use

Number of subjects within the Intent-to-treat population with available data

Posted

Mean

Standard Deviation

Days

Through hospital discharge, an average of 105 days for placebo and 108 days for INO

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000

Secondary

Severity of Bronchopulmonary Dysplasia

Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.

Number of subjects within the Intent-to-treat population with available data

Posted

Count of Participants

Participants

36 weeks

ID	Title	Description
OG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
OG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Inhaled Nitric Oxide	Inhaled Nitric Oxide Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.	12	229	105	229	169	229
EG001	Placebo	Nitrogen Placebo Placebo: Nitrogen gas will be administered in the same manner as the experimental drug.	8	220	100	220	143	220

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA (15.1)	Non-systematic Assessment	EG00034 affected229 at risk EG00134 affected220 at risk
Necrotising enterocolitis neonatal	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG00011 affected229 at risk EG00115 affected220 at risk
Sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG00025 affected229 at risk EG00127 affected220 at risk
Anemia neonatal	Blood and lymphatic system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0004 affected229 at risk EG0016 affected220 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0002 affected229 at risk EG0014 affected220 at risk
Hemolytic anemia	Blood and lymphatic system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Bradycardia	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0011 affected220 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Pneumopericardium	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Cardiac arrest	Cardiac disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Persistent fetal circulation	Congenital, familial and genetic disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0012 affected220 at risk
Adrenogenital syndrome	Congenital, familial and genetic disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Hereditary spherocytosis	Congenital, familial and genetic disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0008 affected229 at risk EG0014 affected220 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0002 affected229 at risk EG0011 affected220 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0011 affected220 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Esophageal perforation	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Hyperbilirubinemia	Hepatobiliary disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0007 affected229 at risk EG0014 affected220 at risk
Group B streptococcus neonatal sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0003 affected229 at risk EG0010 affected220 at risk
Pneumonia	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0003 affected229 at risk EG0017 affected220 at risk
Septic shock	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0003 affected229 at risk EG0011 affected220 at risk
Fungal sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0002 affected229 at risk EG0010 affected220 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0002 affected229 at risk EG0012 affected220 at risk
Urinary tract infection	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0002 affected229 at risk EG0012 affected220 at risk
Bacterial sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0012 affected220 at risk
Beta hemolytic streptococcal infection	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Enterococcal sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0012 affected220 at risk
Staphylococcal bacteremia	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Staphylococcal infection	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Abdominal abscess	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Enterobacter sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0012 affected220 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Lung abscess	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Meningitis candida	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Tracheitis	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Bacterial test positive	Investigations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
CST culture positive	Investigations	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0011 affected220 at risk
Candida test positive	Investigations	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0013 affected220 at risk
Hydrocephalus	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0003 affected229 at risk EG0012 affected220 at risk
Intraventricular hemorrhage neonatal	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0003 affected229 at risk EG0013 affected220 at risk
Cerebral ventricle dilatation	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Encephalomalacia	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Hemorrhage intracranial	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Periventricular leukomalacia	Nervous system disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0011 affected220 at risk
Renal failure	Renal and urinary disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0011 affected220 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0012 affected220 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0004 affected229 at risk EG0015 affected220 at risk
Infantile apnoeic attack	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0002 affected229 at risk EG0010 affected220 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0013 affected220 at risk
Pulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Thoracotomy	Surgical and medical procedures	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Hypotension	Vascular disorders	MedDRA (15.1)	Non-systematic Assessment	EG0007 affected229 at risk EG0012 affected220 at risk
Aortic thrombosis	Vascular disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Arterial spasm	Vascular disorders	MedDRA (15.1)	Non-systematic Assessment	EG0001 affected229 at risk EG0010 affected220 at risk
Hypoperfusion	Vascular disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk
Thrombosis	Vascular disorders	MedDRA (15.1)	Non-systematic Assessment	EG0000 affected229 at risk EG0011 affected220 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG00066 affected229 at risk EG00150 affected220 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG00029 affected229 at risk EG00129 affected220 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG00013 affected229 at risk EG0018 affected220 at risk
Feeding disorder neonatal	Metabolism and nutrition disorders	MedDRA (15.1)	Non-systematic Assessment	EG00010 affected229 at risk EG00112 affected220 at risk
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG00029 affected229 at risk EG00121 affected220 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG00012 affected229 at risk EG00112 affected220 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Non-systematic Assessment	EG00010 affected229 at risk EG00111 affected220 at risk

ID	Term
D001997	Bronchopulmonary Dysplasia

Ancestor Terms

ID	Term
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D045462	Endothelium-Dependent Relaxing Factors
D009584	Nitrogen

Ancestor Terms

ID	Term
D014665	Vasodilator Agents
D002317	Cardiovascular Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases