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Clinical Trial ARTICLE Provisionally accepted The full-text will be published soon. Notify me

Front. Pediatr. | doi: 10.3389/fped.2018.00364

Placental circulation intact trial (PCI-T) - resuscitation with the placental circulation intact versus cord milking for very preterm infants: a feasibility study.

 Simone Pratesi1*, Simona Montano1,  Stefano Ghirardello2,  Fabio Mosca2, Luca Boni3, Lorenzo Tofani3 and  Carlo Dani4
  • 1Division of Neonatology, Azienda Ospedaliero-Universitaria Careggi, Italy
  • 2Neonatal Intensive Care Unit, Department of Mother and Infant Science, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Italy
  • 3Clinical Trials Coordinating Center, Department of Human Pathology and Oncology, Tumour Institute of Tuscany, Italy
  • 4Department of Neuroscience, Psychology, Drug Research and Child Health, University of Florence, Università degli Studi di Firenze, Italy

Background
Preterm newborns receiving briefly delayed cord clamping or cord milking at birth have better neonatal outcomes. However, the time frame in which both these procedures are performed (<60 s of life) is too short to explore the possible beneficial effects on early infant postnatal adaptation and outcomes of a prolonged transfusion strategy associated with neonatal respiration.

Methods/Design
We have designed a randomized, multicenter, controlled two-phase study: phase 1 to assess the feasibility of carrying out the protocol in a large randomized trial, and phase 2 to assess the efficacy of bedside assistance with intact placental circulation for 3 min in comparison to cord milking to improve outcome in the neonatal period; we present here the feasibility and safety phase of the study. Outcomes included feasibility (recruitment rate of two patients per month, compliance with the trial interventions, completeness of data collection, >90% of infants receiving echographic assessments in the first 24 h) and safety variables (5 min Apgar score, delivery room intubation rate, CRIB II score, admission temperature, maximum hemoglobin concentration and hematocrit in the first 24 h and maximum serum bilirubin value) in the two study groups. We also evaluated the same safety variables in infants delivered during the study period but not recruited.

Results
A total of 40 infants were enrolled. In all cases the protocol was completed and all feasibility outcomes were reached. Infants assisted with an intact placental circulation have a higher 5 min Apgar score but their admission temperature was lower than milked infants. Delivery room intubation rate, CRIB II score and peak serum bilirubin value were comparable in both groups. Infants who were not subjected to a placental transfusion strategy (excluded patients) had a higher delivery room intubation rate with respect to both study groups.

Conclusion
Delaying cord clamping until 3 min of life was challenging but feasible and appeared to be safe. However, admission temperature must be strictly monitored and a more efficacious warming system could be implemented to prevent hypothermia during the procedure.

Keywords: delayed cord clamping (DCC), Preterm birth (PTB), randomized trial, Neonatal care at the bedside, cord milking, placental circulation intact

Received: 21 Aug 2018; Accepted: 09 Nov 2018.

Edited by:

Michael P. Meyer, Middlemore Hospital, New Zealand

Reviewed by:

Hans Fuchs, University Hospital Freiburg, Germany
Anup C. Katheria, Sharp Mary Birch Hospital for Women & Newborns, United States
Lindsay F. Mildenhall, Counties Manukau District Health Board, New Zealand  

Copyright: © 2018 Pratesi, Montano, Ghirardello, Mosca, Boni, Tofani and Dani. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dr. Simone Pratesi, Azienda Ospedaliero-Universitaria Careggi, Division of Neonatology, Florence, Italy, simone.pratesi@tiscali.it