Who is sponsoring NCT03916159?

NCT03916159 is sponsored by Universitätsklinikum Köln.

What condition does NCT03916159 study?

NCT03916159 studies Very Low Birth Weight Infant, Placental Transfusion, Anemia.

Is NCT03916159 still recruiting?

NCT03916159 is currently completed. Last updated 8 November 2023.

Last reviewed 2023-11-08 · How we verify

NCT03916159: EXPLAIN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 8 November 2023

What this trial tests

NA trial testing Extrauterine placental transfusion (Intervention group) in Very Low Birth Weight Infant in 60 participants. Completed in 24 October 2023.

Timeline

1 May 2019

Primary endpoint
5 December 2021

24 October 2023

Quick facts

Lead sponsor	Universitätsklinikum Köln
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	60
Start date	1 May 2019
Primary completion	5 December 2021
Estimated completion	24 October 2023
Sites	1 location across Germany

Drugs / interventions tested

Extrauterine placental transfusion (Intervention group)
Delayed cord clamping (Control group)

Conditions studied

Very Low Birth Weight Infant — all drugs for Very Low Birth Weight Infant →
Placental Transfusion — all drugs for Placental Transfusion →
Anemia — all drugs for Anemia →

Sponsor

Universitätsklinikum Köln — full company profile →

Who can join

24 Weeks and older, any sex, with Very Low Birth Weight Infant or Placental Transfusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Extrauterine Placental Perfusion and Oxygenation in Infants With Very Low Birth Weight: A Randomized Clinical Trial.
Kuehne B, Grüttner B, Hellmich M, Hero B, et al · · 2023 · cited 6× · PMID 37921769 · DOI 10.1001/jamanetworkopen.2023.40597
Cytokine patterns in very low birth weight infants under different cord clamping strategies: preliminary EXPLAIN trial data.
Kuehne B, Majjouti M, Wilhelm J, Butzer SK, et al · · 2026 · PMID 42260466 · DOI 10.1186/s12887-026-07097-7
Cerebral Oxygen Saturation During Less-Invasive Surfactant Administration Using a High-Pressure CPAP Respiratory Support Delivery Room Protocol-A Cohort Study.
Trieschmann J, Verhoef A, Kribs A, Mehler K, et al · · 2026 · PMID 42136053 · DOI 10.1111/apa.70591
Neurodevelopmental Outcomes of Very Low Birth Weight Infants Following Extrauterine Placental Perfusion: A Follow-Up Study.
Kuehne B, Hellmich M, Heine E, Kribs A, et al · · 2025 · PMID 40251781 · DOI 10.1111/apa.70101

Verify or expand the search:

Other recruiting trials for Very Low Birth Weight Infant

Currently open trials in the same condition.

NCT06555315 — Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic) · NA · recruiting
NCT05308134 — Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM) · NA · recruiting
NCT04640805 — Targeted Fortification of Pasteurized Donor Human Milk · NA · active not recruiting
NCT05399667 — Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program · active not recruiting
NCT04239508 — Swiss Neonatal Network & Follow-up Group · recruiting

Other Universitätsklinikum Köln trials

Trials by the same sponsor.

NCT06771700 — S-ICD Implantation: US Based Pilot Study · NA · recruiting
NCT06388382 — Investigation of the Audible ICD Alert Tone · recruiting
NCT05713708 — S-ICD Electrode Registry · unknown
NCT06063811 — Ventricular Tachycardia Ablation in LVAD Patients · unknown
NCT05389241 — Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03916159 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitätsklinikum Köln
Last refreshed: 8 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03916159.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing