title: Management of hypotension in preterm infants (The HIP Trial): a randomised controlled trial of hypotension management in extremely low gestational age newborns.
abstract: BACKGROUND
  Extremely preterm babies (delivered at <28 completed weeks of gestation) 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 long-term disability or die compared to those who are not. Despite the widespread use of drugs to treat hypotension in such infants, evidence for efficacy is lacking, and the effect of these agents on long-term outcomes is unknown.
  
  
  OBJECTIVE
  In extremely preterm babies, restricting the use of dopamine when mean blood pressure (BP) values fall below a nominal threshold and using clinical criteria to determine escalation of support ('restricted' approach) will result in improved neonatal and longer-term developmental outcomes. RESEARCH PLAN: In an international multi-centre randomised trial, 830 infants born at <28 weeks of gestation, and within 72 h of birth, will be allocated to 1 of 2 alternative treatment options (dopamine vs. restricted approach) to determine the better strategy for the management of BP, using a conventional threshold to commence treatment. The first co-primary outcome of survival without brain injury will be determined at 36 weeks' postmenstrual age and the second co-primary outcome (survival without neurodevelopmental disability) will be assessed at 2 years of age, corrected for prematurity.
  
  
  CONCLUSIONS
  It is essential that appropriately designed trials be performed to define the most appropriate management strategies for managing low BP in extremely preterm babies.
authors.affiliation: Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, University College Cork, Wilton, Cork, Ireland.
authors.forename: E M
authors.initials: EM
authors.lastname: Dempsey
authors.forename: K J
authors.initials: KJ
authors.lastname: Barrington
authors.forename: N
authors.initials: N
authors.lastname: Marlow
authors.forename: C P
authors.initials: CP
authors.lastname: O'Donnell
authors.forename: J
authors.initials: J
authors.lastname: Miletin
authors.forename: G
authors.initials: G
authors.lastname: Naulaers
authors.forename: P-Y
authors.initials: PY
authors.lastname: Cheung
authors.forename: D
authors.initials: D
authors.lastname: Corcoran
authors.forename: G
authors.initials: G
authors.lastname: Pons
authors.forename: Z
authors.initials: Z
authors.lastname: Stranak
authors.forename: D
authors.initials: D
authors.lastname: Van Laere
mesh_terms: D062186:Arterial Pressure / Q000187:drug effects*; D001930:Brain Injuries / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D002657:Child Development; D002675:Child, Preschool; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004298:Dopamine / Q000009:adverse effects / Q000627:therapeutic use*; D005060:Europe; D005440:Fluid Therapy / Q000009:adverse effects; D005865:Gestational Age; D006801:Humans; D007022:Hypotension / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014662:Vasoconstrictor Agents; D004298:Dopamine