Status:
TERMINATED
Treatment of Hypotension of Prematurity (TOHOP)
Lead Sponsor:
UMC Utrecht
Conditions:
Hypotension
Eligibility:
All Genders
24-30 years
Phase:
NA
Brief Summary
Hypotension in the very preterm infant (gestational age \[GA\] \<32 wks) is a frequently occurring clinical problem. Although no real consensus has been reached on the definition of hypotension in the...
Detailed Description
Rationale: Hypotension in the very preterm infant (gestational age \[GA\] \<32wks) is a frequently occurring clinical problem. Although no real consensus has been reached on the definition of hypotens...
Eligibility Criteria
Inclusion
- Idiopathic arterial hypotension as defined by a mean BP in mmHg less than the GA in weeks at birth.
- Written parental consent
Exclusion
- Prior inclusion indirect clinical or direct laboratory evidence of poor organ/tissue perfusion (plasma lactate \>6 mmol/L on two consecutive measurements and/or urine production \<0.6 mL/kg/h for a 6-hour period
- Clinically and/or microbiologically proven sepsis
- Major congenital abnormalities
- Postnatal age at the time of the development of systemic hypotension \>72 hours
- No arterial line for continuously monitoring of blood pressure
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01434251
Start Date
September 1 2011
End Date
February 1 2021
Last Update
December 16 2024
Active Locations (1)
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1
Wilhemlina Childrens Hostpital/University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 EA