orepinephrine for the management of hypotension in premature and full-term neonates

Withdrawn

• Conditions: hypotension; low blood pressure; 10011954

• Registration Number: NL-OMON42050
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

1) A gestational age between 24+0 and 42+0 weeks
2) <1 month old
3) Hypotension* as indication for treatment with norepinephrine
* Hypotension is defined as: mean arterial blood pressure < total number of completed weeks of gestational age

Exclusion Criteria

1) Chromosomal defects
2) Major congenital malformations that increase the risk of death or adverse neurodevelopmental outcome
3) Infants with hypotension during treatment with extracorporeal membrane oxygenation

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is change in blood pressure and systemic blood flow.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are effects on the cardiac function, effects on the<br /><br>pulmonary condition, effects on tissue perfusion and adverse effects during<br /><br>hospitalization. </p><br>