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Hypotension in Preterm Infants (HIP) randomised trial
Eugene M Dempsey1, Keith J Barrington2, Neil Marlow3
1Department of Paediatric and Child Health and INFANT Research Centre, University College Cork, Cork, Ireland g.dempsey@ucc.ie.
Insights
Restricting inotrope use in premature infants with low blood pressure (BP) did not significantly affect survival without brain injury. This study suggests similar outcomes between standard and restrictive BP management strategies in neonates.
Area of Science:
- Neonatalogy
- Pediatric Cardiology
- Clinical Trials
Background:
- Low blood pressure (BP) is common in preterm infants.
- Inotropes are frequently used to manage hypotension in neonates.
- Evidence is limited on optimal BP management strategies.
Purpose of the Study:
- To investigate if restricting inotrope use impacts survival without significant brain injury in preterm infants.
- To compare standard versus restrictive management of low BP in infants born before 28 weeks of gestation.
Main Methods:
- A double-blind, placebo-controlled randomized trial was conducted across 10 European and Canadian sites.
- Infants born before 28 weeks of gestation with persistent low BP and no severe intraventricular hemorrhage were enrolled.
- Participants received either standard dopamine infusion or a restrictive placebo (5% dextrose) infusion for low BP management.
Main Results:
- The trial was terminated early due to low recruitment.
- No significant difference in survival without severe brain injury was observed between the standard (62%) and restrictive (69%) groups (p=0.58).
- The standard group required fewer additional treatments for low BP (38% vs 66%, p=0.038).
Conclusions:
- Despite limitations in statistical power, no major differences in clinical outcomes were found between standard and restrictive BP management.
- The findings provide preliminary data to inform future research on managing hypotension in extremely preterm infants.
- Further powered studies are needed to definitively assess the impact of different BP management strategies.
Objective:
To 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.
Design:
Double-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.
Setting:
10 sites across Europe and Canada.
Participants:
Infants 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.
Intervention:
Participants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).
Primary Outcome:
Survival to 36 weeks of PMA without severe brain injury.
Results:
The 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).
Conclusion:
Though 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 Number:
NCT01482559, EudraCT 2010-023988-17.
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