Avoiding Hypotension in Preterm Neonates (AHIP)

Medical University of Graz

Status: Completed

Conditions: Hypotension

Treatments: Device: NIRS not visible and treatment as usual; Device: NIRS visible and predefined interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT01910467

15351

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: Under 6 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

NIRS visible and predefined interventions

Experimental group

Description:

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.

Treatment:

Device: NIRS visible and predefined interventions

NIRS not visible and treatment as usual

Other group

Description:

NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual')

Treatment:

Device: NIRS not visible and treatment as usual