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.

INTRODUCTION

Up to 50% of preterm infants admitted to intensive care units require cardiocirculatory support. The aim of the present study was to assess whether simultaneous monitoring of cerebral tissue oxygenation index (cTOI) and peripheral tissue oxygenation index (pTOI) using near-infrared spectroscopy (NIRS) in combination with dedicated intervention guidelines may help avoiding arterial hypotension and catecholamine administration in preterm neonates.

STUDY DESIGN

Preterm neonates <37 weeks of gestation were included in a single center randomized controlled study. Blood pressure was measured non-invasively or invasively. In the NIRS group, simultaneous cTOI and pTOI monitoring was used starting within 6 h after birth for 24 h to calculate changes in cTOI/pTOI ratio over time. Depending on these changes, interventions including echocardiography, administration of volume or patent ductus arteriosus treatment were performed. In the control group, only routine monitoring and treatment were performed and NIRS signals were not visible. The primary outcome was burden of hypotension within 48 h after initiation of NIRS monitoring.

RESULTS

49 preterm neonates were included in each group: NIRS group 33.1 (32.0-34.0) (median: 25-75 centile) weeks of gestation and control group 33.4 (32.3-34.3) weeks of gestation. In the NIRS group, echocardiography was performed in 17 preterm neonates due to NIRS measurements, whereby six neonates received further treatment. Percentage of neonates with any hypotensive episode during the 48-h observational period was 32.6% in the NIRS group and 44.9% in the control group ( = 0.214). Burden of hypotension (i.e., %mmHg of mean arterial pressure < gestational age) was 0.0 (0.0-2.1) mmHg h in the NIRS group and 0.4 (0.0-3.3) mmHg h in the control group ( = 0.313), with observed burden of hypotension being low in both groups. No severe adverse reactions were observed.

CONCLUSION

In preterm neonates using simultaneous peripheral and cerebral NIRS measurements for early detection of centralization followed by predefined interventions led to a non-significant reduction in burden of arterial hypotension.

CLINICAL TRIAL REGISTRATION

www.ClinicalTrials.gov, identifier: NCT01910467.