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Feasibility study of early blood pressure management in extremely preterm infants

Beau J Batton1, Lei Li, Nancy S Newman

  • 1Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA. bbatton@siumed.edu

The Journal of Pediatrics
|February 17, 2012
PubMed

Insights

This pilot study found that a randomized controlled trial for blood pressure management in extremely preterm infants was not feasible due to low enrollment and consent rates. Future trials may need waivers of consent and alternative medications.

Area of Science:

  • Neonatal medicine
  • Clinical trial methodology

Background:

  • Extremely preterm infants often experience low blood pressure (BP).
  • Effective BP management is crucial for neonatal outcomes.
  • Previous research on BP management in this population is limited.

Purpose of the Study:

  • To determine the feasibility of conducting a randomized placebo-controlled trial (RCT) for blood pressure management in extremely preterm infants.

Main Methods:

  • A prospective pilot randomized controlled trial (RCT) was conducted.
  • Infants born between 23-0/7 and 26-6/7 weeks gestation with low BP were enrolled.
  • Infants received either dopamine or placebo infusion, and hydrocortisone or placebo medication.

Main Results:

  • Only 3% of screened infants were enrolled, with 17% of eligible infants enrolled.
  • Low eligibility and consent rates were major barriers.
  • Early indomethacin use excluded many infants due to potential drug interactions.

Conclusions:

  • The pilot RCT was not feasible due to low enrollment and consent.
  • Future RCTs may require a waiver of consent for emergency care research.
  • The risk of intestinal perforation with combined hydrocortisone and indomethacin may necessitate using only inotropic agents.
Abstract

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