ID

40358

Beschreibung

Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00922532

Link

https://clinicaltrials.gov/show/NCT00922532

Stichworte

Versionen (1)
  1. 12.04.20 12.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. April 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hypoxic Respiratory Failure With Pulmonary Hypertension NCT00922532

Englisch

Eligibility Hypoxic Respiratory Failure With Pulmonary Hypertension NCT00922532

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
preterm infants who:
Beschreibung

Preterm Infant | Inclusion criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1]
C4048294
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C1550543
are in-born at < 30 weeks gestational age
Beschreibung

Gestational Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0017504
weigh 500-1250 grams
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
have hypoxic respiratory failure requiring mechanical ventilation with fio2 > 0.8 to maintain sao2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
Beschreibung

Hypoxic respiratory failure | Mechanical ventilation Required | Inspired fraction of oxygen | Oxygen saturation measurement | Status post Surfactant Exogenous

Datentyp

boolean

Alias
UMLS CUI [1]
C3805211
UMLS CUI [2,1]
C0199470
UMLS CUI [2,2]
C1514873
UMLS CUI [3]
C0428167
UMLS CUI [4]
C0523807
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C2825078
UMLS CUI [5,3]
C0205228
have minimal parenchymal lung disease by chest x ray
Beschreibung

Lung disease Parenchymal Minimal | Chest X-ray

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C4277702
UMLS CUI [1,3]
C0547040
UMLS CUI [2]
C0039985
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
preterm infants who:
Beschreibung

Preterm Infant | Exclusion Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1]
C4048294
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1550543
have ten minute apgar score < 5
Beschreibung

Apgar Score

Datentyp

boolean

Alias
UMLS CUI [1]
C0003533
have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
Beschreibung

Abnormality Life Threatening | Abnormality cardiac | Abnormality thoracic | Chromosomal anomalies | Lung hypoplasia in those with diaphragmatic hernia | Child Without Intensive care

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0018787
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0817096
UMLS CUI [4]
C0008626
UMLS CUI [5]
C3278237
UMLS CUI [6,1]
C0008059
UMLS CUI [6,2]
C0332288
UMLS CUI [6,3]
C0085559
have bilateral grade iv intraventricular hemorrhage (ivh)
Beschreibung

Ventricular hemorrhage Bilateral Grade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240059
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0441800
are dependent on right to left shunting to maintain the systemic circulation
Beschreibung

Patient need for Right to left cardiac shunt | Maintenance Systemic blood circulation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C2711956
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0678860
have received prior ino therapy
Beschreibung

Administration of inhaled nitric oxide

Datentyp

boolean

Alias
UMLS CUI [1]
C1135443
have had treatment with investigational medications
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Hypoxic Respiratory Failure With Pulmonary Hypertension NCT00922532

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Preterm Infant | Inclusion criteria Fulfill
Item
preterm infants who:
boolean
C4048294 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Gestational Age
Item
are in-born at < 30 weeks gestational age
boolean
C0017504 (UMLS CUI [1])
Body Weight
Item
weigh 500-1250 grams
boolean
C0005910 (UMLS CUI [1])
Hypoxic respiratory failure | Mechanical ventilation Required | Inspired fraction of oxygen | Oxygen saturation measurement | Status post Surfactant Exogenous
Item
have hypoxic respiratory failure requiring mechanical ventilation with fio2 > 0.8 to maintain sao2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
boolean
C3805211 (UMLS CUI [1])
C0199470 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0428167 (UMLS CUI [3])
C0523807 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C2825078 (UMLS CUI [5,2])
C0205228 (UMLS CUI [5,3])
Lung disease Parenchymal Minimal | Chest X-ray
Item
have minimal parenchymal lung disease by chest x ray
boolean
C0024115 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C0039985 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Preterm Infant | Exclusion Criteria Fulfill
Item
preterm infants who:
boolean
C4048294 (UMLS CUI [1])
C0680251 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Apgar Score
Item
have ten minute apgar score < 5
boolean
C0003533 (UMLS CUI [1])
Abnormality Life Threatening | Abnormality cardiac | Abnormality thoracic | Chromosomal anomalies | Lung hypoplasia in those with diaphragmatic hernia | Child Without Intensive care
Item
have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
boolean
C1704258 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C1704258 (UMLS CUI [3,1])
C0817096 (UMLS CUI [3,2])
C0008626 (UMLS CUI [4])
C3278237 (UMLS CUI [5])
C0008059 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0085559 (UMLS CUI [6,3])
Ventricular hemorrhage Bilateral Grade
Item
have bilateral grade iv intraventricular hemorrhage (ivh)
boolean
C0240059 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Patient need for Right to left cardiac shunt | Maintenance Systemic blood circulation
Item
are dependent on right to left shunting to maintain the systemic circulation
boolean
C0686904 (UMLS CUI [1,1])
C2711956 (UMLS CUI [1,2])
C0024501 (UMLS CUI [2,1])
C0678860 (UMLS CUI [2,2])
Administration of inhaled nitric oxide
Item
have received prior ino therapy
boolean
C1135443 (UMLS CUI [1])
Investigational New Drugs
Item
have had treatment with investigational medications
boolean
C0013230 (UMLS CUI [1])
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