ID

34463

Description

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

Link

https://clinicaltrials.gov/show/NCT01088997

Keywords

  1. 1/17/19 1/17/19 -
  2. 5/28/21 5/28/21 -
  3. 5/28/21 5/28/21 -
  4. 6/11/21 6/11/21 -
  5. 6/14/21 6/14/21 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Persistent Pulmonary Hypertension of Newborn (PPHN) NCT01088997

Eligibility Persistent Pulmonary Hypertension of Newborn (PPHN) NCT01088997

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
gestational age > 34 weeks
Description

ID.1

Data type

boolean

post-natal age < 10 days
Description

ID.2

Data type

boolean

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 >75% fio2 for >6 hours while on ino
Description

ID.3

Data type

boolean

absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
Description

ID.4

Data type

boolean

an in-dwelling arterial catheter to facilitate painless sampling
Description

ID.5

Data type

boolean

currently on ino or plan to start ino before enrollment
Description

ID.6

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

ID.7

Data type

boolean

clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
Description

ID.8

Data type

boolean

currently on ecmo or plan to initiate ecmo within 2 hours of enrollment
Description

ID.9

Data type

boolean

Similar models

Eligibility Persistent Pulmonary Hypertension of Newborn (PPHN) NCT01088997

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
gestational age > 34 weeks
boolean
ID.2
Item
post-natal age < 10 days
boolean
ID.3
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 >75% fio2 for >6 hours while on ino
boolean
ID.4
Item
absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
boolean
ID.5
Item
an in-dwelling arterial catheter to facilitate painless sampling
boolean
ID.6
Item
currently on ino or plan to start ino before enrollment
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
lethal non-cardiac congenital anomalies including diaphragmatic hernia
boolean
ID.8
Item
clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
boolean
ID.9
Item
currently on ecmo or plan to initiate ecmo within 2 hours of enrollment
boolean

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