Avoiding Hypotension in Preterm Neonates

N/ACompletedNCT01910467

Medical University of Graz98 enrolled

Overview

Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number of hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared spectroscopy in combination with predefined interventions and secondly to explore the potential impact on cerebral injury and mortality. Hypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation ratio investigators will reduce hypotensive episodes and use of catecholamines which will reduce cerebral injury and mortality. Methods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300) will be measured for 24h starting \<6 hours postpartum. When cTOI/pTOI ratio increases \>5% within a 6h period, predefined interventions will be performed. Primary outcome parameter will be duration of hypotensive episodes and use of catecholamines during the first 48h after birth. Secondary outcome parameters will be cerebral injury and mortality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hypotension

Interventions

NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases \>5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.

Eligibility

Sex: ALLMax age: 6 Hours

Medical Language ↔ Plain English

Inclusion Criteria: * preterm neonates * decision to conduct full life support * written informed consent * age \<6 hours * no use of catecholamines before start of NIRS measurements Exclusion Criteria: * no decision to conduct full life support * no written informed consent * age \>6 hours * use of catecholamines before start of NIRS measurements * congenital malformation

Outcomes

Primary Outcomes

Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours

Time frame: 48 hours

Secondary Outcomes

Cerebral injury by cerebral ultrasound

From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.

Time frame: up to 16 weeks

Mortality