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Completed

NCT Number: NCT01910467

Avoiding Hypotension in Preterm Neonates

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Pediatrics, Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 not visible and treatment as usual

Device

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

Primary outcomes

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

    Time frame: 48 hours

Secondary outcomes

  1. Cerebral injury by cerebral ultrasound

    Time frame: up to 16 weeks

    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.

  2. Mortality

    Time frame: up to 16 weeks

Other outcomes

  1. Neonatal morbidities

    Time frame: up to 16 weeks

    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.

  2. Heart rate

    Time frame: 48 hours

  3. Blood pressure

    Time frame: 48 hours

  4. Arterial oxygen saturation

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Acronym: AHIP

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2013
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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