Related Experiment Video
Updated: Apr 17, 2026
Transcutaneous Microcirculatory Imaging in Preterm Neonates
Published on: December 31, 2015
Advancing evidence in preterm neonatal medicine
Pamela K Donahue1, Karen A Robinson
1Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Maryland; Department of Population, Family, and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. pdonohu2@jhmi.edu.
Insights
Establishing evidence-based care for premature infants is challenging due to numerous barriers in randomized controlled trials (RCTs). Addressing these obstacles is crucial for improving treatment outcomes for preterm infants.
Area of Science:
- Neonatal research
- Evidence-based medicine
- Clinical trial methodology
Background:
- Randomized controlled trials (RCTs) are essential for evidence-based healthcare but are underutilized in premature infant care.
- Significant barriers hinder the establishment of a robust evidence base for preterm infant interventions.
Purpose of the Study:
- To examine the barriers to conducting high-quality randomized controlled trials (RCTs) for premature infants.
- To highlight delays in translating research evidence into clinical practice for neonatal care.
- To propose the development of guidance for good clinical research practice in preterm infants.
Main Methods:
- Review of existing literature and landmark trials in neonatal care.
- Analysis of systematic exclusion of children from drug trials.
- Examination of infant vulnerability and family burden in consent processes.
- Assessment of challenges in standardizing measurements and subgroup definitions for systematic reviews.
Main Results:
- Barriers include child exclusion from drug trials, infant vulnerability, consent burdens, and lack of standardized measurements.
- Delays in evidence implementation are linked to clinician knowledge, attitudes, and behaviors.
- Landmark trials serve as examples illustrating these challenges.
Conclusions:
- A concerted effort is needed to overcome barriers in neonatal RCTs.
- Developing specific guidance for good clinical research practice is essential for preterm infants.
- Synthesizing the totality of evidence requires improved research methodologies and implementation strategies.
Abstract:
Few interventions and treatments for premature infants have undergone the rigors of a randomized controlled trial (RCT), the cornerstone of evidence-based healthcare. Multiple barriers in establishing a quality evidence base for the care of preterm infants are examined including the systematic exclusion of children from drug trials, vulnerability of the infants, burden to families of the consent process for RCTs, and the lack of standard measurements and subgroup definitions that impede systematic reviews. Delays in getting evidence into practice are highlighted, including clinician knowledge of existing evidence, attitudes about the evidence, and behavior. Landmark trials are used as examples. Finally, a call for the research community to develop guidance on good clinical research practice for preterm infants is offered that will allow the synthesis of the totality of evidence.
