Neonatal hypotension
Conditions
Interventions
Product Name: Sterile Dopamine concentrate BP
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Dopamine hydrochloride BP
Sponsors
Liverpool Women's NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants born at less than 28 weeks gestation who require dopamine to treat systemic hypotension. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are: 1) Known structural cardiac defects 2) Structural cardiac defects that become apparent during the study (not Patent foramen ovale) 3) Absence of arterial access as BP is not measured reliably in these infants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the variation in response to Dopamine is related to varaition in the circulating levels of Dopamine in infants born less than 28 weeks.;Secondary Objective: To determine how much of this variation is due to myocardial damage, patent ductus arteriosus and single neucleotide polymorphisms.; Primary end point(s): Whether systemic hypotension responds to a moderate dose of dopamine, according to the following definitions: Systemic hypotension: Mean BP less than 10th centile for gestational age based on data in Cunningham et al., (Early Human Development 1999, 56:151-6) for more than 1 hour. Dopamine infusion: starting at 2.5 micrograms / kg / min and increasing in steps of 2.5 micrograms / kg / min if infant has systemic hypotension for more than 30 minutes at a single step. Lack of response to a moderate dose of dopamine: continuation of systemic hypotension despite infusion of dopamine at a dose of 10 micrograms / kg / min for 30 minutes. | — |
Countries
United Kingdom
Outcome results
None listed