Clinical trial NCT01910467: Avoiding Hypotension in Preterm Neonates
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 98
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Cerebral injury by cerebral ultrasound
timeFrame: up to 16 weeks
measure: Mortality
timeFrame: up to 16 weeks
Other outcomes:
measure: Neonatal morbidities
timeFrame: up to 16 weeks
measure: Heart rate
timeFrame: 48 hours
measure: Blood pressure
timeFrame: 48 hours
measure: Arterial oxygen saturation
timeFrame: 48 hours
Locations:
city: Graz
country: Austria
facility: Dep. of Pediatrics, Medical University of Graz
state: Styria
Study officials:
affiliation: Dep. of Pediatrics, Medical University of Graz
name: Gerhard Pichler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoeller N, Baik-Schneditz N, Schwaberger B, Mileder L, Urlesberger B, Pichler G. Cerebral and peripheral muscle oxygenation and perfusion: Course in moderate and late preterm neonates during the first day after birth. Physiol Int. 2020 Jul 17;107(2):267-279. doi: 10.1556/2060.2020.00028.
citation: Pichler G, Holler N, Baik-Schneditz N, Schwaberger B, Mileder L, Stadler J, Avian A, Pansy J, Urlesberger B. Avoiding Arterial Hypotension in Preterm Neonates (AHIP)-A Single Center Randomised Controlled Study Investigating Simultaneous Near Infrared Spectroscopy Measurements of Cerebral and Peripheral Regional Tissue Oxygenation and Dedicated Interventions. Front Pediatr. 2018 Feb 1;6:15. doi: 10.3389/fped.2018.00015. eCollection 2018.