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NCT01866982: PREMOD
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
NA trial testing Umbilical Cord Milking in Intraventricular Hemorrhage in 197 participants. Completed in 10 January 2018.
1 December 2014
Quick facts
| Lead sponsor | Sharp HealthCare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 197 |
| Start date | 2 July 2013 |
| Primary completion | 1 December 2014 |
| Estimated completion | 10 January 2018 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Umbilical Cord Milking
- Delayed Cord Clamping
Conditions studied
- Intraventricular Hemorrhage — all drugs for Intraventricular Hemorrhage →
Sponsor
Sharp HealthCare
Who can join
Eligibility, any sex, with Intraventricular Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants.
Katheria AC, Truong G, Cousins L, Oshiro B, et al · · 2015 · cited 137× · PMID 26122803 · DOI 10.1542/peds.2015-0368 -
Umbilical cord milking improves transition in premature infants at birth.
Katheria A, Blank D, Rich W, Finer N. · · 2014 · cited 46× · PMID 24709780 · DOI 10.1371/journal.pone.0094085 -
A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age.
Katheria A, Garey D, Truong G, Akshoomoff N, et al · · 2018 · cited 43× · PMID 29246467 · DOI 10.1016/j.jpeds.2017.10.037 -
Necrotizing Enterocolitis: What's New and What's Next?
Sha C, Sander WR, Bass K, Hsieh H, et al · · 2025 · cited 1× · PMID 41096926 · DOI 10.3390/ijms26199660
Verify or expand the search:
- PubMed search for NCT01866982
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Umbilical Cord Milking
Trials testing the same drug.
- NCT03681314 — Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU) · NA · withdrawn
- NCT03682042 — Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up · NA · recruiting
- NCT03731611 — Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency · NA · completed
- NCT03621956 — Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping · NA · completed
- NCT03798093 — Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI) · NA · completed
Other recruiting trials for Intraventricular Hemorrhage
Currently open trials in the same condition.
- NCT07273643 — Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With · recruiting
- NCT06814964 — rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage · Phase 1 · recruiting
- NCT06466811 — Prediction of Undesired Obstruction in External Ventricular Drains. · recruiting
- NCT05849077 — Optimization of Saturation Targets And Resuscitation Trial (OptiSTART) · NA · recruiting
- NCT05568264 — Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit · NA · recruiting
Other Sharp HealthCare trials
Trials by the same sponsor.
- NCT07301385 — Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety a · NA · recruiting
- NCT07176117 — Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants · NA · not yet recruiting
- NCT07028359 — Sharp Health Companion App for Cataract Surgery Preparation and Recovery · NA · completed
- NCT04413097 — Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants · NA · active not recruiting
- NCT04848727 — Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01866982 (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 Sharp HealthCare
- Last refreshed: 24 May 2018
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/NCT01866982.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing