Early and continuously raising of blood pressure may prevent fluctuations of cerebral blood flow in very low birth weight infants (VLBW) especially in VLBW infants without cerebral autoregulation!

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013094

Enrollment

Registered

2017-10-05

Start date

2017-10-16

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

P07 I95

Interventions

Group 1: During the first 72 hours of life the cerebral saturation, MAP and remaining vital signs are recorded. Arterial hypotension is defined at the University Hospital of Heidelberg as a MAP of les

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: preterm infant with a gestational age less than 30 weeks

Exclusion criteria

Exclusion criteria: heart failure

Design outcomes

Primary

Measure	Time frame
Mean arterial blood pressure is observed in premature infants during the first 72 hours of life without and with hypotension therapy. If a central arterial catheter is indwelled, the arterial blood pressure is monitored continuously. Otherwise, non-invasive measurements are obtained using the oscillometric technique with an appropriate-sized cuff.	—

Secondary

Measure	Time frame
During the first 72 hours of life the cerebral saturation is measured using near infrared spectroscopy, a non-invasive, continuous bedside measurement technique. The cerebral fractional tissue oxygen extraction can be calculated from this, which is an indirect measure of cerebral blood flow. In addition, the vital signs including blood pressure are recorded during routine monitoring. If a central arterial catheter is indwelled, the arterial blood pressure is monitored continuously. Otherwise, non-invasive measurements are obtained using the oscillometric technique. The mean arterial pressure and cerebral fractional tissue oxygen extraction are correlated. If there is cerebral autoregulation in premature infants, fluctuations of the MAP have no influence on the cerebral blood flow, i. e. there is no correlation.	—

Measure

Time frame

During the first 72 hours of life the cerebral saturation is measured using near infrared spectroscopy, a non-invasive, continuous bedside measurement technique. The cerebral fractional tissue oxygen extraction can be calculated from this, which is an indirect measure of cerebral blood flow. In addition, the vital signs including blood pressure are recorded during routine monitoring. If a central arterial catheter is indwelled, the arterial blood pressure is monitored continuously. Otherwise, non-invasive measurements are obtained using the oscillometric technique. The mean arterial pressure and cerebral fractional tissue oxygen extraction are correlated. If there is cerebral autoregulation in premature infants, fluctuations of the MAP have no influence on the cerebral blood flow, i. e. there is no correlation.

—

Countries

Germany

Contacts

Public ContactTina Heinzmann

Kinderklinik Heidelberg, Abteilung Neonatologie

tina.heinzmann@med.uni-heidelberg.de062215632366

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026