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Delivery Room Assistance With the Placental Circulation Intact (PCI-T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671305
Recruitment Status : Recruiting
First Posted : February 2, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Simone Pratesi, University of Florence

Brief Summary:

Preterm newborns receiving placental transfusion at birth (a volume of blood coming from the placenta towards the newborn till the cord is left unclamped) have better neonatal outcomes (in particular reduction of intraventricular hemorrhage all grade). The placental transfusion strategies performed in preterm babies at delivery have been delayed cord clamping and cord milking. Both experimental strategies do not explore the contribution of the start of breathing on placental transfusion, as performed in a small time frame (30-60 seconds for delayed clamping and less than 20 sec for cord milking). To assist the newborn bedside near to the delivering mother, leaving the cord unclamped, would allow to explore the contribution of breathing,both spontaneously started or assisted by initial steps in stabilization, on early postnatal adaptation.

The purpose of the present study is to assess the feasibility and effectiveness of delivery room assistance with the placental circulation intact in comparison to cord milking for improving outcomes in very preterm newborns.


Condition or disease Intervention/treatment Phase
Placental Transfusion Procedure: placental circulation intact Procedure: cord milking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Delivery Room Assistance With the Placental Circulation Intact: Effects on Early Postnatal Adaptation and Outcome of Preterm Babies. Study Protocol for a Randomized Control Trial (the PCI-trial)
Actual Study Start Date : April 9, 2016
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: placental circulation intact
preterm newborns assisted bedside with placental circulation intact
Procedure: placental circulation intact
bedside assistance with placental circulation intact during first 3 minutes of life

Active Comparator: cord milking
preterm newborns who receive cord milking before assistance performed in a routine setting
Procedure: cord milking
neonatal assistance in a standard setting after cord milking (milking four times 20 cm of cord)




Primary Outcome Measures :
  1. reduction of incidence of severe intraventricular hemorrhage, chronic lung disease or mortality [ Time Frame: up to 36 weeks of postconceptional age ]
    The Outcome Measure is a composite of 3 main adverse events (severe intraventricular hemorrhage, chronic lung disease or mortality), that each patient may present or not present during the time frame. It is expected a reduction of the number of participants presenting with one or more of them. Severe intraventricular hemorrhage will be assessed by cerebral echography using Papile classification, chronic lung disease will be assessed using Jobe et al diagnostic criteria.



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Ages Eligible for Study:   23 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm newborns with gestational age between 23+0 and 29+6 weeks
  • Informed consent available

Exclusion Criteria:

  • Major congenital malformation
  • Hydrops fetalis, placental abruption
  • Rh isoimmunization
  • Twin pregnancy
  • Absence of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671305


Contacts
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Contact: Simone Pratesi, MD 00390557947792 simone.pratesi@unifi.it
Contact: Carlo Dani, MD cdani@unifi.it

Locations
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Italy
UTIN-Neonatologia, Ospedale di Venere Recruiting
Bari, Italy
Contact: Flavia Petrillo, MD       flavia.age@hotmail.it   
Contact: Antonello Del Vecchio, MD         
UOC di Neonatologia e TIN, Dipartimento Materno-Infantile, Ospedale Maggiore Recruiting
Bologna, Italy
Contact: Giovanna Mescoli, MD       giovanna.mescoli@ausl.bologna.it   
Contact: Fabrizio Sandri, MD       f.sandri@ausl.bologna.it   
Neonatal Intensive Care Unit, Department of Maternal and Infant Health, Careggi University Hospital Recruiting
Florence, Italy, 50139
Contact: Simone Pratesi, MD    +39 055 7946358    simone.pratesi@unifi.it   
Contact: Carlo Dani, MD    +39 055 7947671    cdani@unifi.it   
Neonatal Intensive Care Unit, IRCCS Cà Granda Foundation, Maggiore Policlinico Hospital Recruiting
Milan, Italy
Contact: Stefano Ghirardello, MD       stefano.ghirardello@mangiagalli.it   
Contact: Fabio Mosca, MD       fabio.mosca@unimi.it   
SC TIN-Neonatologia, Azienda Ospedaliera di Perugia Recruiting
Perugia, Italy
Contact: Cristiana Germini, MD       cristiana.germini@ospedale.perugia.it   
Contact: Stefania Troiani, MD       stefania.troiani@ospedale.perugia.it   
SOD di Neonatologia dell'Ospedale Infermi di Rimini Recruiting
Rimini, Italy
Contact: miria natile, MD       miria.natile@auslromagna.it   
Contact: Gina Ancora, MD       gina.ancora@auslromagna.it   
UOC di Neonatologia e TIN, Azienda ULSS8 Berica Recruiting
Vicenza, Italy
Contact: Stefania Vedovato, MD       stefania.vedovato@aulss8.veneto.it   
Contact: Massimo Bellettato, MD       massimo.bellettato@aulss8.veneto.it   
Sponsors and Collaborators
University of Florence
Investigators
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Principal Investigator: Simone Pratesi, MD Careggi University Hospital, Florence, Italy
Study Director: Carlo Dani, MD Careggi University Hospital, Florence, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simone Pratesi, MD, PhD, University of Florence
ClinicalTrials.gov Identifier: NCT02671305    
Other Study ID Numbers: 152-2014
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Simone Pratesi, University of Florence:
delayed cord clamping
cord milking
bedside neonatal resuscitation