Hypotension in Preterm Infants (HIP) randomised trial

Abstract

ObjectiveTo determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).ConclusionThough this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.Trial registration numberNCT01482559, EudraCT 2010-023988-17.

Blood Pressure Goals: Is Cerebral Saturation the New Mean Arterial Pressure?

“…Some reasons include direct effects of illness, medications, immaturity, and nonhomogeneity across premature infants within the same GA. 14 Recommendations (1992) from the Joint Working Party of British Association of Perinatal Medicine were to maintain MAP greater than the infants' GA in a millimeter of mercury. 15 The hypotension in preterm infants 16 study showed no outcome differences (while lacking power) between infants treated with dopamine or placebo with a blood pressure goal of over GA. 14 Other work showed GA as an adequate MAP threshold. 15,17 Original studies suggested that MAP goals under 30 mm Hg may lead to an increased risk of IVH.…”

“…The "Avoiding Hypotension in Preterm Neonates" trial published by Drs. Thewissen et al investigated cNIRS values in neonates and developed prescribed interventions based on recorded instabilities 22,23 . The study showed treatment of hypotension with dopamine in extremely preterm infants increases mean arterial blood pressure but does not improve cNIRS values.…”

Blood pressure changes during the first 24 hours of life and the association with the persistence of a patent ductus arteriosus and occurrence of intraventricular haemorrhage

“…Hypotension treatment is a clinical challenge in VLBW infants, and optimal blood pressure ranges are debated [ 39 ]. Considering that infants with normal blood pressure often receive inotropes [ 40 ], restricting inotropes when treating premature infants could be beneficial [ 41 ]. However, it is worth noting that infants with hypotension have worse outcomes than infants with normal blood pressure [ 42 ].…”

Cerebral Oximetry in Preterm Infants–To Use or Not to Use, That Is the Question

“…Ways to increase blood pressure have been widely studied in controlled trials. The clinical benefits, however, has mainly been studied using epidemiological methods, and only very recently a randomized, but unfortunately very underpowered, clinical trial was completed (23). As far as we know, little in this direction is underway for electric cadiometry.…”