Avoiding Hypotension in Preterm Neonates

Not Applicable

Completed

• Conditions: Hypotension
• Interventions: Device: NIRS not visible and treatment as usual; Device: NIRS visible and predefined interventions

• Registration Number: NCT01910467
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Study Start: 2013-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIRS not visible and treatment as usual	NIRS not visible and treatment as usual	NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual')
NIRS visible and predefined interventions	NIRS visible and predefined 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cerebral injury by cerebral ultrasound	up to 16 weeks	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.
Mortality	up to 16 weeks

Trial Locations

Locations (1)

Dep. of Pediatrics, Medical University of Graz; 🇦🇹 Graz, Styria, Austria