Delivery Room Assistance With the Placental Circulation Intact

NCT02671305 | Completed

• 1 other identifier: 152-2014
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 8

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.

Conditions

Placental Transfusion

Keywords

delayed cord clamping; cord milking; bedside neonatal resuscitation

Outcome Measures

Primary Outcomes (1)

• reduction of incidence of severe intraventricular hemorrhage, chronic lung disease or mortality

  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.

  up to 36 weeks of postconceptional age

Study Arms (2)

placental circulation intact

EXPERIMENTAL

preterm newborns assisted bedside with placental circulation intact

Procedure: placental circulation intact

cord milking

ACTIVE COMPARATOR

preterm newborns who receive cord milking before assistance performed in a routine setting

Procedure: cord milking

Interventions

placental circulation intact PROCEDURE

bedside assistance with placental circulation intact during first 3 minutes of life

placental circulation intact

cord milking PROCEDURE

neonatal assistance in a standard setting after cord milking (milking four times 20 cm of cord)

cord milking

Eligibility Criteria

• Age: 23 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (8)

UTIN-Neonatologia, Ospedale di Venere

Bari, Italy

Location

UOC di Neonatologia e TIN, Dipartimento Materno-Infantile, Ospedale Maggiore

Bologna, Italy

Location

Neonatal Intensive Care Unit, Department of Maternal and Infant Health, Careggi University Hospital

Florence, 50139, Italy

Location

Neonatal Intensive Care Unit, IRCCS Cà Granda Foundation, Maggiore Policlinico Hospital

Milan, Italy

Location

San Gerardo Hospital

Monza, Italy

Location

SC TIN-Neonatologia, Azienda Ospedaliera di Perugia

Perugia, Italy

Location

SOD di Neonatologia dell'Ospedale Infermi di Rimini

Rimini, Italy

Location

UOC di Neonatologia e TIN, Azienda ULSS8 Berica

Vicenza, Italy

Location

Related Publications (2)

• Pratesi S, Ciarcia M, Boni L, Ghirardello S, Germini C, Troiani S, Tulli E, Natile M, Ancora G, Barone G, Vedovato S, Bertuola F, Parata F, Mescoli G, Sandri F, Corbetta R, Ventura L, Dognini G, Petrillo F, Valenzano L, Manzari R, Lavizzari A, Mosca F, Corsini I, Poggi C, Dani C; PCI Trial Collaborators. Resuscitation With Placental Circulation Intact Compared With Cord Milking: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450476. doi: 10.1001/jamanetworkopen.2024.50476.

  PMID: 39671198 DERIVED

• Pratesi S, Montano S, Ghirardello S, Mosca F, Boni L, Tofani L, Dani C. Placental Circulation Intact Trial (PCI-T)-Resuscitation With the Placental Circulation Intact vs. Cord Milking for Very Preterm Infants: A Feasibility Study. Front Pediatr. 2018 Nov 27;6:364. doi: 10.3389/fped.2018.00364. eCollection 2018.

  PMID: 30538975 DERIVED

MeSH Terms

Conditions

Fetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Simone Pratesi, MD

  Careggi Hospital

  PRINCIPAL INVESTIGATOR

• Carlo Dani, MD

  Careggi Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 2, 2016
• Study Start: April 9, 2016
• Primary Completion: July 7, 2023
• Study Completion: September 15, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)