Feasibility Study of Early Blood Pressure Management in Extremely Preterm Infants - 23/06/12
, Lei Li, PhD 2, Nancy S. Newman, RN 1, Abhik Das, PhD 3, Kristi L. Watterberg, MD 4, Bradley A. Yoder, MD 5, Roger G. Faix, MD 5, Matthew M. Laughon, MD, MPH 6, Krisa P. Van Meurs, MD 7, Waldemar A. Carlo, MD 8, Rosemary D. Higgins, MD 9, Michele C. Walsh, MD, MS 1Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
Reprint requests: Beau J. Batton, MD, Southern Illinois University School of Medicine, Department of Pediatrics, Division of Neonatology, PO Box 19676, Springfield, IL 62794.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 Two infants were withdrawn from the study because of the potential risk of intestinal perforation with simultaneous administration of hydrocortisone and indomethacin.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.
Le texte complet de cet article est disponible en PDF.Mots-clés : BP, GA, NRN, RCT, UAC
Plan
| The National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development provided grant support, including funding from the Best Pharmaceuticals for Children Act, for the Neonatal Research Network’s Early Blood Pressure Pilot Study. Data collected at participating sites of the National Institute of Child Health and Human Development Neonatal Research Network were transmitted to RTI International, the data coordinating center for the network, which stored, managed, and analyzed the data for this study. The authors declare no conflicts of interest. |
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| Registered with ClinicalTrials.gov: NCT00874393. |
Vol 161 - N° 1
P. 65 - juillet 2012 Retour au numéro
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