Cord pilot trial: update to randomised trial protocol.

Area of Science:

• Neonatal medicine
• Clinical trial methodology
• Perinatal care

Background:

• The Cord Pilot Trial investigates umbilical cord clamping timing (immediate vs. deferred) for very preterm infants (<32 weeks gestation).
• This paper presents protocol updates and changes for phase 2 of the pilot trial, following initial recruitment from March 2013 to February 2014.
• The trial is registered under ISRCTN21456601.

Purpose of the Study:

• To assess the feasibility of a large-scale UK randomized trial comparing immediate versus deferred umbilical cord clamping.
• To update the pilot trial protocol and introduce changes for phase 2 recruitment and follow-up procedures.
• To refine methods for data collection and outcome assessment in very preterm infants.

Main Methods:

• Phase 2 introduced an electronic randomization system at three pilot sites.
• Child follow-up at 2 years will primarily use the Ages and Stages Questionnaire (ASQ), with potential for Bayley Scales of Infant Development III (Bayley-III) if funding allows.
• Accuracy of intraventricular hemorrhage diagnosis via cranial ultrasound will be assessed through scan quality evaluation and independent adjudication.

Main Results:

• The study focuses on protocol updates and feasibility assessments for a larger trial.
• Data on compliance and outcomes will be analyzed by allocated group for all recruited participants.
• Methodological refinements aim to improve the reliability and efficiency of data collection for future trials.

Conclusions:

• The updated protocol and methods aim to enhance the feasibility of conducting a definitive large-scale randomized trial.
• Refinements in randomization and follow-up procedures are crucial for gathering reliable data on cord clamping timing.
• The pilot trial's ongoing development supports the eventual establishment of evidence-based guidelines for preterm infant care.