Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants

NCT03916159 | Completed DMC

• 2 other identifiers: 18-232DRKS00017041
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section. The investigators hypothesize that EPT provides higher blood volume during neonatal transition and improves neonatal outcome of VLBW infants.

Conditions

Very Low Birth Weight Infant; Placental Transfusion; Anemia

Keywords

extrauterine placental transfusion; delayed cord clamping; neonatal resuscitation

Outcome Measures

Primary Outcomes (1)

• Hematocrit

  Mean Hematocrit in the first 24 hours of life

  0 - 24 hours of life

Secondary Outcomes (19)

• Cerebral tissue oxygen saturation

  During first hour of life

• Mean airway pressure

  During first hour of life

• Mean tidal volume

  During first hour of life

• Heart rate

  During first hour of life

• Blood oxygen saturation

  During first hour of life

Study Arms (2)

Extrauterine Placental Transfusion EPT

EXPERIMENTAL

Intervention group

Procedure: Extrauterine placental transfusion (Intervention group)

Delayed cord clamping DCC

ACTIVE COMPARATOR

Control group

Procedure: Delayed cord clamping (Control group)

Interventions

Extrauterine placental transfusion (Intervention group) PROCEDURE

At delivery by caesarean section, the infant is born with the placenta still attached via the umbilical cord and placental transfusion is performed at least 1 minute but not more than 10 minutes by holding the placenta \~40-50cm above the babies' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.

Extrauterine Placental Transfusion EPT

Delayed cord clamping (Control group) PROCEDURE

At delivery by caesarean section, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 30 seconds with initiation of respiratory support by mask CPAP after cord clamping.

Delayed cord clamping DCC

Eligibility Criteria

• Age: 24 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Birth weight \< 1500 gram ("very low birth weight infant")
• Delivery by caesarean section
• Gestational age \> 23+6 weeks

You may not qualify if:

• Vaginal delivery
• Fetal or maternal risk (i.e. compromise, emergency c-section)
• Congenital anomalies and/or major cardiac defects
• Placental abruption or previa with hemorrhage
• Placenta accreta or increta
• Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)
• Parents declined study

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (1)

University Hospital of Cologne, Department of pediatrics

Cologne, Germany

Location

Related Publications (3)

• Kuehne B, Kirchgaessner C, Becker I, Kuckelkorn M, Valter M, Kribs A, Oberthuer A. Mask Continuous Positive Airway Pressure Therapy with Simultaneous Extrauterine Placental Transfusion for Resuscitation of Preterm Infants - A Preliminary Study. Biomed Hub. 2018 Jun 26;3(2):1-10. doi: 10.1159/000488926. eCollection 2018 May-Aug.

  PMID: 31988958 BACKGROUND

• Kuehne B, Gruttner B, Hellmich M, Hero B, Kribs A, Oberthuer A. Extrauterine Placental Perfusion and Oxygenation in Infants With Very Low Birth Weight: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2340597. doi: 10.1001/jamanetworkopen.2023.40597.

  PMID: 37921769 RESULT

• Kuehne B, Hellmich M, Heine E, Kribs A, Mehler K, Oberthuer A. Neurodevelopmental Outcomes of Very Low Birth Weight Infants Following Extrauterine Placental Perfusion: A Follow-Up Study. Acta Paediatr. 2025 Sep;114(9):2246-2252. doi: 10.1111/apa.70101. Epub 2025 Apr 18.

  PMID: 40251781 DERIVED

MeSH Terms

Conditions

Fetofetal Transfusion; Anemia

Interventions

Umbilical Cord Clamping; Control Groups

Condition Hierarchy (Ancestors)

Anemia, Neonatal; 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; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• André Oberthuer, MD

  University hospital of Cologne, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 16, 2019
• Study Start: May 1, 2019
• Primary Completion: December 5, 2021
• Study Completion: October 24, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)