Study completed and recruitment closed
What is HiP?
HiP (Management of Hypotension In the Preterm Infant) is an international, multi-centre, randomised control clinical trial involving dopamine versus placebo.
The HiP study recruits extremely preterm infants (born at less than 28 weeks). The study is an exploration of the management of hypotension in the preterm infant.
How does HiP work?
The primary objective of HiPis to determine whether an observational approach, rather than a standard dopamine approach to the management of hypotension in these infants within the first 72 hrs of life, improves the chances of:
- Survival which is free from neurodevelopmental disability at 2 years corrected GA.
- Survival without significant brain injury at 36 weeks corrected GA.
To this end, each infant involved in the trial will receive a structured neurological assessment, a developmental assessment using the Bayley Scales of Infant Development (BSID-III), functional measures of motor (GMFCS), sensory and communication impairments, and a standardised parent-report evaluation of social and adaptive functions. These tests will give an overview of the infant’s cognitive ability, motor status and behaviour.
Extremely preterm infants are frequently diagnosed with hypotension and treated with inotropic and pressor drugs in the immediate postnatal period. Dopamine is the most commonly used first-line drug. Babies who are treated for hypotension more frequently sustain brain injury, have longterm disability and a higher chance of mortality, compared to those who are not diagnosed with hyoptnsion. Despite the widespread use of drugs to treat hypotension in such infants, evidence of efficacy is lacking, and the effect of these agents on long-term health is unknown.