Avoiding Hypotension in Preterm Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Avoiding Hypotension in Preterm Neonates (AHIP) - A Randomised Controlled Study on Near Infrared Spectroscopy Monitoring of Peripheral-muscle and Cerebral Oxygenation With Defined Interventions Versus Routine Monitoring and Treatment in Preterm Neonates

Conditions
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Hypotension

Intervention / Treatment
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* Device: NIRS visible and predefined interventions
* Device: NIRS not visible and treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRS visible and predefined interventions<br>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. | Device: NIRS visible and predefined interventions<br>* 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.<br>|
| Other: NIRS not visible and treatment as usual<br>NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual') | Device: NIRS not visible and treatment as usual<br>* NIRS not visible and the patients will be treated according to routine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 16 weeks | 
| Mortality |  | up to 16 weeks |