Early blood pressure, antihypotensive therapy and outcomes at 18–22 months’ corrected age in extremely preterm infants

Investigate relationships between early blood pressure (BP) changes, receipt of anti-hypotensive therapy, and 18 – 22 month corrected age (CA) outcomes for extremely preterm infants

Feasibility Study of Early Blood Pressure Management in Extremely Preterm Infants

To assess the feasibility of a randomized placebo controlled trial (RCT) of blood pressure (BP) management for extremely preterm infants

Early blood pressure, antihypotensive therapy and outcomes at 18-22 months\u27 corrected age in extremely preterm infants.

OBJECTIVE: To investigate the relationships between early blood pressure (BP) changes, receipt of antihypotensive therapy and 18-22 months\u27 corrected age (CA) outcomes for extremely preterm infants. DESIGN: Prospective observational study of infants 23(0/7)-26(6/7) weeks\u27 gestational age (GA). Hourly BP values and antihypotensive therapy exposure in the first 24 h were recorded. Four groups were defined: infants who did or did not receive antihypotensive therapy in whom BP did or did not rise at the expected rate (defined as an increase in the mean arterial BP of ≥5 mm Hg/day). Random-intercept logistic modelling controlling for centre clustering, GA and illness severity was used to investigate the relationship between BP, antihypotensive therapies and infant outcomes. SETTING: Sixteen academic centres of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. MAIN OUTCOME MEASURES: Death or neurodevelopmental impairment/developmental delay (NIDD) at 18-22 months\u27 CA. RESULTS: Of 367 infants, 203 (55%) received an antihypotensive therapy, 272 (74%) survived to discharge and 331 (90%) had a known outcome at 18-22 months\u27 CA. With logistic regression, there was an increased risk of death/NIDD with antihypotensive therapy versus no treatment (OR 1.836, 95% CI 1.092 to 3.086), but not NIDD alone (OR 1.53, 95% CI 0.708 to 3.307). CONCLUSIONS: Independent of early BP changes, antihypotensive therapy exposure was associated with an increased risk of death/NIDD at 18-22 months\u27 CA when controlling for risk factors known to affect survival and neurodevelopment. CLINICAL TRIAL REGISTRATION NUMBER: clinicaltrials.gov #NCT00874393

Feasibility Study of Early Blood Pressure Management in Extremely Preterm Infants

OBJECTIVE: To assess the feasibility of a randomized placebo controlled trial (RCT) of blood pressure (BP) management for extremely preterm infants. STUDY DESIGN: This was a prospective pilot RCT of infants 23(0/7) – 26(6/7) weeks gestation who had protocol-defined low BP in the first 24 postnatal hours. Enrolled infants were administered a study infusion (dopamine or placebo) and a study syringe medication (hydrocortisone or placebo). RESULTS: Of the 366 infants screened, 119 (33%) had low BP, 58 (16%) met all entry criteria, and 10 (3%) were enrolled. 161 (44%) infants were ineligible because they received early indomethacin. Only 17% of eligible infants were enrolled. Problems with consent included insufficient time, parent unavailability, and physician unwillingness to enroll critically ill infants. Two infants were withdrawn from the study due to the potential risk of intestinal perforation with simultaneous administration of hydrocortisone and indomethacin. CONCLUSIONS: This pilot RCT was not feasible due to low eligibility and consent rates. An RCT of BP management for extremely preterm infants may require a waiver of consent for research in emergency care. The frequent use of early indomethacin and the associated risk of intestinal perforation when used with hydrocortisone may limit future investigations to only inotropic medications