Avoiding Hypotension in Preterm Neonates

Hypotension Clinical Trial

— AHIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910467
• Other study ID #: 15351
• Status: Completed
• Phase: N/A
• First received: July 19, 2013
• Last updated: January 16, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

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.
• NIRS not visible and treatment as usual
NIRS not visible and the patients will be treated according to routine

Locations

Country	Name	City	State
Austria	Dep. of Pediatrics, Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal morbidities	From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.	up to 16 weeks
Other	Heart rate		48 hours
Other	Blood pressure		48 hours
Other	Arterial oxygen saturation		48 hours
Primary	Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours		48 hours
Secondary	Cerebral injury by cerebral ultrasound	From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.	up to 16 weeks
Secondary	Mortality		up to 16 weeks