EARLY BLOOD PESSURE MANAGEMENT IN EXTREMELY PRETERM INFANTS FEASIBILITY

$2,078M01FY2010RRNIH

University Of New Mexico, Albuquerque NM

Investigators

Linked publications & trials

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Study Aim(s): Primary aim: Evaluate the feasibility of performing a randomized controlled trial (RCT) of BP management in this group of vulnerable patients in the immediate postnatal period. We define feasibility as the ability to safely identify and randomize a sufficient number of patients within a reasonable time period and to demonstrate that the study can by initiated as planned without specified protocol violations exceeding 20%. This includes the ability to safely identify patients, approach the parents of identified patients, and provide parents with information about a complex intervention at a stressful time. We will evaluate our ability to obtain informed consent in a timely manner, randomize a sufficient number of patients in a reasonable time frame, and demonstrate that the study can be conducted as designed. Secondary aims: 1. To investigate the safety of administering hydrocortisone, dopamine, or (only) placebo therapy to extremely preterm infants with low BP in the first 24 postnatal hours. This includes the ability to safely administer study drugs without significant drug toxicity or more frequent severe adverse events. Rates of in-hospital morbidity (grade III or IV IVH, cystic PVL, Necrotizing Enterocolitis (NEC) requiring surgical intervention, Retinopathy of Prematurity (ROP) requiring laser surgery, or Bronchopulmonary Dysplasia (BPD), one week survival, survival to hospital discharge, and use of open-label anti-hypotensive therapies will be monitored. An absolute difference of 20% in any of these events across subgroups will be considered acceptable.

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