ID

42329

Description

Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn; ODM derived from: https://clinicaltrials.gov/show/NCT01088997

Lien

https://clinicaltrials.gov/show/NCT01088997

Mots-clés

Versions (5)
  1. 2019-01-17 2019-01-17 -
  2. 2021-05-28 2021-05-28 -
  3. 2021-05-28 2021-05-28 -
  4. 2021-06-11 2021-06-11 -
  5. 2021-06-14 2021-06-14 - Sarah Riepenhausen
Détendeur de droits

Children's Hospital of Philadelphia

Téléchargé le

14 juni 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Persistent Pulmonary Hypertension of Newborn (PPHN) NCT01088997

Anglais

Eligibility Persistent Pulmonary Hypertension of Newborn (PPHN) NCT01088997

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
gestational age > 34 weeks
Description

Gestational age

Type de données

boolean

Alias
UMLS CUI [1]
C0017504
post-natal age < 10 days
Description

Post-natal age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
hypoxemia defined by: oxygenation index (oi) >15 (mean airway pressure x fraction of inspired oxygen x 100 /pao2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. or mechanically ventilated and with >75percent fio2 for >6 hours while on ino
Description

Hypoxemia | analysis of arterial blood gases and pH, oi measurement | mechanical ventilation fio2 administration of ino

Type de données

boolean

Alias
UMLS CUI [1]
C0700292
UMLS CUI [2,1]
C0150411
UMLS CUI [2,2]
C1278185
UMLS CUI [3,1]
C0199470
UMLS CUI [3,2]
C0428167
UMLS CUI [3,3]
C1135443
absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
Description

Congenital heart disease absent two-dimensional echocardiography | clinical assessment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0152021
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0013524
UMLS CUI [2,1]
C0152021
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C4534461
an in-dwelling arterial catheter to facilitate painless sampling
Description

Indwelling arterial catheter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0581447
UMLS CUI [1,2]
C0439848
currently on ino or plan to start ino before enrollment
Description

Administration of inhaled nitric oxide

Type de données

boolean

Alias
UMLS CUI [1]
C1135443
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
lethal non-cardiac congenital anomalies including diaphragmatic hernia
Description

Lethal non-cardiac congenital anomalies | diaphragmatic hernia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1302234
UMLS CUI [2,1]
C0152021
UMLS CUI [2,2]
C1705847
UMLS CUI [3]
C0019284
clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
Description

Hemorrhage | platelet count measurement | blood coagulation disorders evidence laboratory procedures

Type de données

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C0005779
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0022885
currently on ecmo or plan to initiate ecmo within 2 hours of enrollment
Description

ECMO current | ECMO planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015357
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C0015357
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Persistent Pulmonary Hypertension of Newborn (PPHN) NCT01088997

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gestational age
Item
gestational age > 34 weeks
boolean
C0017504 (UMLS CUI [1])
Post-natal age
Item
post-natal age < 10 days
boolean
C0001779 (UMLS CUI [1])
Hypoxemia | analysis of arterial blood gases and pH, oi measurement | mechanical ventilation fio2 administration of ino
Item
hypoxemia defined by: oxygenation index (oi) >15 (mean airway pressure x fraction of inspired oxygen x 100 /pao2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. or mechanically ventilated and with >75percent fio2 for >6 hours while on ino
boolean
C0700292 (UMLS CUI [1])
C0150411 (UMLS CUI [2,1])
C1278185 (UMLS CUI [2,2])
C0199470 (UMLS CUI [3,1])
C0428167 (UMLS CUI [3,2])
C1135443 (UMLS CUI [3,3])
Congenital heart disease absent two-dimensional echocardiography | clinical assessment
Item
absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
boolean
C0152021 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013524 (UMLS CUI [1,3])
C0152021 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C4534461 (UMLS CUI [2,3])
Indwelling arterial catheter
Item
an in-dwelling arterial catheter to facilitate painless sampling
boolean
C0581447 (UMLS CUI [1,1])
C0439848 (UMLS CUI [1,2])
Administration of inhaled nitric oxide
Item
currently on ino or plan to start ino before enrollment
boolean
C1135443 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lethal non-cardiac congenital anomalies | diaphragmatic hernia
Item
lethal non-cardiac congenital anomalies including diaphragmatic hernia
boolean
C0000768 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0152021 (UMLS CUI [2,1])
C1705847 (UMLS CUI [2,2])
C0019284 (UMLS CUI [3])
Hemorrhage | platelet count measurement | blood coagulation disorders evidence laboratory procedures
Item
clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
boolean
C0019080 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0005779 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0022885 (UMLS CUI [3,3])
ECMO current | ECMO planned
Item
currently on ecmo or plan to initiate ecmo within 2 hours of enrollment
boolean
C0015357 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0015357 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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