Avoiding Hypotension in Preterm Neonates

NCT01910467 | Completed

• 1 other identifier: 15351
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

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

  48 hours

Secondary Outcomes (2)

• Cerebral injury by cerebral ultrasound

  up to 16 weeks

• Mortality

  up to 16 weeks

Other Outcomes (4)

• Neonatal morbidities

  up to 16 weeks

• Heart rate

  48 hours

• Blood pressure

  48 hours

Study Arms (2)

NIRS visible and predefined interventions

EXPERIMENTAL

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

NIRS not visible and treatment as usual

OTHER

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

Interventions

NIRS visible and predefined interventions DEVICE

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.

NIRS visible and predefined interventions

NIRS not visible and treatment as usual DEVICE

NIRS not visible and the patients will be treated according to routine

NIRS not visible and treatment as usual

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm neonates
• decision to conduct full life support
• written informed consent
• age \<6 hours
• no use of catecholamines before start of NIRS measurements

You may not qualify if:

• no decision to conduct full life support
• no written informed consent
• age \>6 hours
• use of catecholamines before start of NIRS measurements
• congenital malformation

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Dep. of Pediatrics, Medical University of Graz

Graz, Styria, 8036, Austria

Location

Related Publications (2)

• 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.

  PMID: 32692715 DERIVED

• 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.

  PMID: 29450194 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gerhard Pichler, MD

  Dep. of Pediatrics, Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dr.

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 29, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

AU (1)