Avoiding Hypotension in Preterm Neonates

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01910467

Acronym

AHIP

Enrollment

Registered

2013-07-29

Start date

2013-11-30

Completion date

2016-12-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

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.

Interventions

DEVICENIRS 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.

DEVICENIRS not visible and treatment as usual

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Hours

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Cerebral injury by cerebral ultrasound	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.
Mortality	up to 16 weeks	—

Other

Measure	Time frame	Description
Neonatal morbidities	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.
Arterial oxygen saturation	48 hours	—
Heart rate	48 hours	—
Blood pressure	48 hours	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026