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Very Low Birth Weight InfantEXPLAINNCT03916159

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

A study testing Extrauterine placental transfusion (Intervention group) in people with Very Low Birth Weight Infant and Placental Transfusion, run by Universitätsklinikum Köln at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 weeks and older
What is being tested?
Extrauterine placental transfusion (Intervention group)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGermany
Study dates
1 May 2019to 24 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 weeks and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital of Cologne, Department of pediatrics

    Cologne

Other trials in Germany

About this study

Official title: Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial

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.

Read the detailed description

This prospective randomized controlled study will be conducted among 2 groups, all of them are preterm infants with birth weight less than 1500 g ("very low birth weight" (VLBW)) who are delivered by caesarean section, in the first interventional group an extrauterine placental transfusion (EPT) will be done during neonatal resuscitation with respiratory pressure support. There will be a delayed cord clamping (DCC) of at least 30 - 60 seconds in the control group, before starting neonatal resuscitation with respiratory support.

In EPT approach preterm born infants are delivered by caesarean section with the placenta still attached to the infant via the umbilical cord. Then, placental transfusion is performed up to several 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 may give more blood in babies delivered by cesarean section and may improve perfusion during the fetal-to-neonatal transition with impact on neonatal outcome.

Being tested
Extrauterine placental transfusion (Intervention group), Delayed cord clamping (Control group)
Keywords
extrauterine placental transfusion, delayed cord clamping, neonatal resuscitation
Medical subject headings
Fetofetal Transfusion, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extrauterine placental transfusion (Intervention group)Procedure or surgery

    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.

  • Delayed cord clamping (Control group)Procedure or surgery

    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.

Study groups in NCT03916159
Study groupRoleWhat they receive
Extrauterine Placental Transfusion EPTExperimentalIntervention group
Receives: Procedure: Extrauterine placental transfusion (Intervention group)
Delayed cord clamping DCCActive comparatorControl group
Receives: Procedure: Delayed cord clamping (Control group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematocrit

    Mean Hematocrit in the first 24 hours of life

    Measured: 0 - 24 hours of life

Secondary outcomes (19)

  1. Cerebral tissue oxygen saturation

    Transcutaneous measured cerebral tissue oxygen saturation given in percent (%) during neonatal resuscitation

    Measured: During first hour of life

  2. Mean airway pressure

    Mean airway pressure given in cmH2O during neonatal resuscitation

    Measured: During first hour of life

  3. Mean tidal volume

    Mean tidal volume given in milliliter (ml) during neonatal resuscitation

    Measured: During first hour of life

  4. Heart rate

    Heart rate given in beats-per-minute (bpm) during neonatal resuscitation

    Measured: During first hour of life

  5. Blood oxygen saturation

    Transcutaneous measured blood oxygen saturation given in percent (%) during neonatal resuscitation

    Measured: During first hour of life

  6. Admission temperature

    Mean temperature at admission

    Measured: Admission to ward is up to 120 minutes of age

  7. All Grade Intraventricular Hemorrhage (IVH)

    Incidence of any intraventricular hemorrhage (grades 1-4)

    Measured: Up to 28 days of life

  8. All Grade BPD

    Incidence of Bronchopulmonary Disease (BPD) (all grades)

    Measured: At the corrected age of 36 weeks

  9. Spontaneous Pneumothorax/Pneumoperitoneum

    Early incidence of spontaneous pneumothorax and/or pneumoperitoneum

    Measured: During the first 7 days of life

  10. Spontaneous Pneumothorax/Pneumoperitoneum

    Late incidence of spontaneous pneumothorax and/or pneumoperitoneum

    Measured: Between day 7 and day 28 of life

  11. NEC/SIP with surgery

    Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery

    Measured: During the first 28 days of life

  12. Retinopathy of Prematurity (ROP), higher grades

    Incidence of retinopathy of prematurity with treatment (drugs and/or surgery)

    Measured: At the corrected age of 40 weeks

  13. Death

    Incidence of death in studied infants

    Measured: Until corrected age of 40 weeks

  14. Number of participants who received red blood cell (RBC) transfusion

    Amount of RBC Transfusion [cumulative ml/kg over the first 7 days] in those participants who received RBC transfusion

    Measured: During the first 7 days of life

  15. Hyperbilirubinemia

    Peak bilirubin concentration

    Measured: During the first 14 days of life

  16. Blood Exchange Transfusion

    Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate.

    Measured: During the first 14 days of life

  17. Intubation and Mechanical Ventilation

    Incidence of intubation and time duration of mechanical ventilation

    Measured: During the first 72 hours of life

  18. Intubation and Mechanical Ventilation

    Incidence of intubation and time duration of mechanical ventilation

    Measured: During hospitalization

  19. Neurodevelopmental Outcome

    Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) composite score (motor, cognitive, language)

    Measured: 22-26 month corrected gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start1 May 2019
  3. Primary completion5 Dec 2021
  4. Study completion24 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03916159
Sponsor's protocol ID
18-232
Other IDs
DRKS00017041
Acronym
EXPLAIN
Status last verified
Nov 2023
First submitted
5 Apr 2019
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31988958

  • 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.

    PubMed 37921769

  • Kuehne B, Majjouti M, Wilhelm J, Butzer SK, Kribs A, Alcazar MAA, Mahabir E, Oberthuer A. Cytokine patterns in very low birth weight infants under different cord clamping strategies: preliminary EXPLAIN trial data. BMC Pediatr. 2026 Jun 8;26(1):554. doi: 10.1186/s12887-026-07097-7.

    PubMed 42260466

  • Trieschmann J, Verhoef A, Kribs A, Mehler K, Kuehne B, Oberthuer A. Cerebral Oxygen Saturation During Less-Invasive Surfactant Administration Using a High-Pressure CPAP Respiratory Support Delivery Room Protocol-A Cohort Study. Acta Paediatr. 2026 Sep;115(9):1953-1958. doi: 10.1111/apa.70591. Epub 2026 May 14.

    PubMed 42136053

  • 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.

    PubMed 40251781

Questions about this trial

What is this clinical trial studying?

A study testing Extrauterine placental transfusion (Intervention group) in people with Very Low Birth Weight Infant and Placental Transfusion, run by Universitätsklinikum Köln at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematocrit (time frame: 0 - 24 hours of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03916159, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.

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