Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment

Pediatrics. 2010 Jul;126(1):e215-21. doi: 10.1542/peds.2009-3353. Epub 2010 Jun 29.

Abstract

Objectives: The purposes of this study were to quantify the time and effort involved in obtaining prenatal consent for the Neonatal Research Network Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT) and to determine whether the enrolled infants were representative of the eligible population.

Methods: Eligible subjects were likely to deliver in the SUPPORT gestational age window (24-27(6/7)] weeks). Data included who approached the subjects for consent, how often they approached, the duration of each contact, whether consent was obtained, and whether subjects were enrolled in the trial. Eligible, nonenrolled infants entered into the Neonatal Research Network Generic Database throughout the period of SUPPORT enrollment were compared with enrolled infants.

Results: A total of 2826 women were identified at 18 sites, 2228 were approached for consent, and 1219 (54.7%) agreed. For 76.9% of those approached, <3 visits (mean: 2.0 +/- 1.2 visits) were required to complete the consent process. Of the 659 infants with consent who were delivered within the study window, 611 were enrolled. Mothers who received a neonatal consultation were more likely to give consent (P < .001). The proportion of infants not exposed to steroids was significantly greater in the nonapproached group than in the approached group (20.0% vs 3.4%; P < .0001).

Conclusion: In a trial that involved preterm infants and required prenatal consent, >5 women were identified as being likely to deliver in the SUPPORT gestational age window for each 1 who delivered an enrolled infant.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Cohort Studies
  • Cost-Benefit Analysis
  • Female
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Infant, Premature*
  • Infant, Premature, Diseases / diagnosis
  • Infant, Premature, Diseases / therapy
  • Informed Consent / statistics & numerical data*
  • Intention to Treat Analysis
  • Male
  • Oximetry / methods
  • Patient Compliance
  • Patient Selection
  • Positive-Pressure Respiration
  • Pregnancy
  • Prenatal Diagnosis / economics*
  • Prenatal Diagnosis / methods*
  • Probability
  • Prospective Studies
  • Pulmonary Surfactants / analysis
  • Randomized Controlled Trials as Topic

Substances

  • Pulmonary Surfactants

Grant support