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 earlyindomethacin. 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 Two infants were withdrawn from the study because of the potential risk of intestinal perforation with simultaneous administration of hydrocortisone and indomethacin.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.
RCT Entities:
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 Two infants were withdrawn from the study because of the potential risk of intestinal perforation with simultaneous administration of hydrocortisone and indomethacin.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.
Authors: Anne Greenough; Paul Cheeseman; Vasiliki Kavvadia; Gabriel Dimitriou; Margaret Morton Journal: Eur J Pediatr Date: 2002-04-16 Impact factor: 3.183
Authors: Andrew K Ewer; Wendy Tyler; Andre Francis; Donna Drinkall; Jason O Gardosi Journal: Paediatr Perinat Epidemiol Date: 2003-04 Impact factor: 3.980
Authors: S E Martens; M Rijken; G M S J Stoelhorst; P H T van Zwieten; A H Zwinderman; J M Wit; M Hadders-Algra; S Veen Journal: Early Hum Dev Date: 2003-12 Impact factor: 2.079
Authors: Beau Batton; Lei Li; Nancy S Newman; Abhik Das; Kristi L Watterberg; Bradley A Yoder; Roger G Faix; Matthew M Laughon; Barbara J Stoll; Krisa P Van Meurs; Waldemar A Carlo; Brenda B Poindexter; Edward F Bell; Pablo J Sánchez; Richard A Ehrenkranz; Ronald N Goldberg; Abbot R Laptook; Kathleen A Kennedy; Ivan D Frantz; Seetha Shankaran; Kurt Schibler; Rosemary D Higgins; Michele C Walsh Journal: Pediatrics Date: 2013-05-06 Impact factor: 7.124
Authors: Beau Batton; Lei Li; Nancy S Newman; Abhik Das; Kristi L Watterberg; Bradley A Yoder; Roger G Faix; Matthew M Laughon; Barbara J Stoll; Rosemary D Higgins; Michele C Walsh Journal: Arch Dis Child Fetal Neonatal Ed Date: 2015-11-13 Impact factor: 5.747
Authors: Ningxin Luo; Siyuan Jiang; Patrick J McNamara; Xiaoying Li; Yan Guo; Yang Wang; Junyan Han; Yingping Deng; Yi Yang; Shoo K Lee; Yun Cao Journal: Front Pediatr Date: 2021-04-22 Impact factor: 3.418
Authors: Leeann R Pavlek; Brian K Rivera; Charles V Smith; Joanie Randle; Cory Hanlon; Kristi Small; Edward F Bell; Matthew A Rysavy; Sara Conroy; Carl H Backes Journal: J Pediatr Date: 2021-04-21 Impact factor: 6.314
Authors: Laura E Miller; Matthew M Laughon; Reese H Clark; Kanecia O Zimmerman; Christoph P Hornik; Samia Aleem; P Brian Smith; Rachel G Greenberg Journal: J Perinatol Date: 2021-03-23 Impact factor: 3.225