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Delivery Room Assistance With the Placental Circulation Intact

NCT02671305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2024-06-05

No results posted yet for this study

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

Interventions

PROCEDURE

placental circulation intact

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

PROCEDURE

cord milking

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

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Principal Investigators

  • Simone Pratesi, MD · Careggi Hospital

  • Carlo Dani, MD · Careggi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-09
Primary Completion
2023-07-07
Completion
2023-09-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02671305 on ClinicalTrials.gov