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Randomized Controlled Trial
. 2012 Jul;161(1):65-9.e1.
doi: 10.1016/j.jpeds.2012.01.014. Epub 2012 Feb 14.

Feasibility study of early blood pressure management in extremely preterm infants

Beau J Batton  1 , Lei Li, Nancy S Newman, Abhik Das, Kristi L Watterberg, Bradley A Yoder, Roger G Faix, Matthew M Laughon, Krisa P Van Meurs, Waldemar A Carlo, Rosemary D Higgins, Michele C Walsh; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
Collaborators, Affiliations
Randomized Controlled Trial

Feasibility study of early blood pressure management in extremely preterm infants

Beau J Batton et al. J Pediatr. 2012 Jul.

Abstract

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 to 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. A total of 161 infants (44%) 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 Two infants were withdrawn from the study because of the potential risk of intestinal perforation with simultaneous administration of hydrocortisone and indomethacin.

Conclusions: This pilot RCT was not feasible because of 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.

Trial registration: ClinicalTrials.gov NCT00874393.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure
Figure
Flow diagram of infants. GA = gestational age; BP = blood pressure
See this image and copyright information in PMC

Comment in

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