NCT01910467

Avoiding Hypotension in Preterm Neonates

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 6 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	NIRS not visible and treatment as usual	NIRS not visible and the patients will be treated according to routine

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-07-29
• Last updated: 2017-01-18

Locations

1 site across 1 country: Austria