Avoiding Hypotension in Preterm Neonates

NCT ID: NCT01910467

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NIRS visible and predefined interventions

Intervention Type: 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 not visible and treatment as usual

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

Group Type: OTHER

NIRS not visible and treatment as usual

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

NIRS not visible and treatment as usual

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

Intervention Type: DEVICE

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

• Maximum Eligible Age: 6 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Pichler Gerhard, MD.

Ass. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerhard Pichler, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Pediatrics, Medical University of Graz

Locations

Dep. of Pediatrics, Medical University of Graz

Graz, Styria, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 32692715 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29450194 (View on PubMed)

Other Identifiers

15351

Identifier Type: -

Identifier Source: org_study_id