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Hypotension | Management of Hypotension In the Preterm Infant

Hypotension research study

What is the primary objective of this study?

The HIP trial is a large pragmatic, multinational, randomised trial of two different strategies for the management of hypotension in extremely low gestational age newborns (Standard with dopamine versus a restricted with placebo approach). HYPOTHESIS: A restricted approach to the management of hypotension in extremely low gestational age newborns will result in improved neonatal and long-term developmental outcomes. PRIMARY OBJECTIVE: To determine whether a restricted approach to the management of hypotension compared to using dopamine as first line pressor agent in infants born less than 28 weeks of gestation within the first 72 hrs after birth (transitional period), improves survival without significant brain injury at 36 weeks postmenstrual age (PMA) and improves survival without moderate or severe neurodevelopmental disability at 2 years corrected age.

Who is eligible to participate?

Inclusion Criteria: 1. Gestational age at birth less than 28 completed weeks, i.e. up to and including 27 weeks and 6 days. 2. Within 72 hours of birth 3. An indwelling arterial line, either umbilical or peripheral (e.g. radial, posterior tibial), suitably calibrated and zeroed, to monitor BP with the measuring dome at the level of the infant's mid-axillary line when supine 4. A pre-trial cerebral ultrasound scan demonstrating no evidence of grade 3 or 4 haemorrhage intraventricular haemorrhage (IVH)(i.e. intraparenchymal echodensity or echolucency, with or without acquired cerebral ventriculomegaly) 5. A mean blood pressure 1 mmHg or more below a mean BP value equivalent to the gestational age in completed weeks, which persists over a 15 minute period (mean BP < gestational age) Exclusion Criteria: 1. Considered non-viable by attending clinicians. 2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus, small atrial and/or ventricular septal defect). Infants known to require surgical treatment e.g. congenital diaphragmatic hernia, trache-oesophageal fistula, omphalocele, gastroschisis. Neuromuscular disorders. Frank hypovolaemia. Hydrops Fetalis. 3. Cranial ultrasound abnormality grade 3 IVH or more prior to enrolment

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypotension

Low Blood Pressure

Intraventricular Hemorrhage of Prematurity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Dopamine hydrochlorideActive drug substance 1.5 mg in 1 mL IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min

Drug:Dextrose 5%IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

dextrose 5%IV Infusion

Dopamine HydrochlorideIV Infusion

Study Status

Recruiting

Start Date: January 2015

Completed Date: January 2018

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: First Co-Primary Outcome Measure: Survival to 36 weeks postmenstrual age free of severe brain injury

Secondary Outcome: All cause mortality at 36 weeks gestational age

Study sponsors, principal investigator, and references

Principal Investigator: Eugene Dempsey

Lead Sponsor: University College Cork

Collaborator: Cork University Hospital

More information:https://clinicaltrials.gov/show/NCT01482559

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