Protocol for the implementation of intact cord management during neonatal resuscitation in the delivery room: a multicenter randomized clinical trial

Abstract

Background: Intact cord management has proven benefits for heathy preterm and term newborns. An increased blood transfer reduces the incidence of neonatal complications and the need for transfusions or surfactant, but also increases the haematocrit, haemoglobin and iron stores at birth. Current guidelines only recommend this intervention during cardiopulmonary resuscitation when considered feasible during the “golden minute” assessment. The main objective of this clinical trial is to expand evidence on intact cord management during cardiopulmonary resuscitation, aiming to develop a standardised protocol for its implementation in the delivery room practice. Design and participants: Multicentre, prospective, randomized, open-label, parallel-group clinical trial. Data managers and the statistician will be blinded to the group assignment and independent of the intervention. All pregnant patients without any exclusion criteria admitted for labour to any of the hospitals included will be approached for consent. Before randomization, those newborns not requiring resuscitation will be excluded. Setting: Seven hospitals from the “Servei Catalá de la Salut” will be involved in the study, which is expected to last five years, from sample recruitment to follow-up. Intervention: 158 patients will be randomly assigned following a stratified randomization in a 1:1 ratio between intervention group (intact cord management) and control group (immediate cord clamping). Outcome measures: The main outcome will be the Apgar score at 1, 5 and 10 minutes. Other shot-term outcomes include umbilical cord pH, blood pressure, septic and blood count parameters, complications and survival rates. For the longterm, neurodevelopmental outcomes will be evaluated using the Ages and Stages Questionnaires (3rd edition) during a period of 4 years