Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05170633 · ClinicalTrials.gov registry record · NA
Blood Warming in Preterm Infants to Decrease Hypothermia
A NA study of Preterm Birth and Hypothermia, sponsored by University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT05170633: Recruiting NA study of Preterm Birth and Hypothermia, sponsored by University of South Carolina.
NCT05170633 is a NA study of Preterm Birth and Hypothermia that is actively recruiting participants, run by University of South Carolina. The registered enrollment target is 140 participants, below the 4,406-participant average among 39 other Preterm Birth trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05170633, a NA study of Preterm Birth and Hypothermia, is actively recruiting participants, sponsored by University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by The World Health Organization. Another acute morbidity is anemia in preterm infants due to the prematurity and frequent laboratory testing. Anemia requires correction with a packed red blood cells (PRBC) transfusion. Researchers have previous noted hypothermia during PRBC transfusions in preterm infants. Objective: To use a commercial blood warmer in the neonatal intensive care setting to prevent hypothermic body temperatures (\<36.5°C) in very preterm infants during PRBC transfusions. Process: Based on a completed national survey of neonatal intensive care nurses and PRBC transfusion practices and personal NICU experience, we designed this randomized control trial in 140 very preterm infants in a Southeastern, level III neonatal intensive care unit. Outcomes: Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a lower incidence of central body hypothermia post transfusion (temperatures \<36.5C), compared to infants receiving PRBC transfusions by standard of care. Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a higher post transfusion mean abdominal skin body temperature when compared to infants receiving PRBC transfusions by standard of care. Hypothesis : The results of this trial could show that very preterm infants experience hypothermia during PRBC transfusions, and thus provide the evidence to support the need for warmed PRBC transfusions in very preterm infants nationwide.
Primary Outcome
the occurrence of hypothermia, defined as a mean central temperature \< 36.5°C, in the intervention versus control groups
Conditions Studied
Interventions
- DEVICE Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
Study Locations (1)
South Carolina
- Kayla Everhart - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2026-01-01 |
| Phase | NA |
What NCT05170633 shows while recruiting
NCT05170633 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 4,406-participant average among 39 other Preterm Birth trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) is the first listed.
NCT05170633 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05170633 about?
NCT05170633 is a clinical study titled "Blood Warming in Preterm Infants to Decrease Hypothermia". Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by Th...
What is the current status of trial NCT05170633?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2022-01-01. Estimated completion is 2026-01-01.
What conditions does trial NCT05170633 study?
This clinical trial studies the following conditions: Preterm Birth, Hypothermia, Blood Transfusion Complication.
What interventions are being tested in trial NCT05170633?
The interventions under investigation include: Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) (DEVICE).
Who is sponsoring clinical trial NCT05170633?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05170633 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Preterm Birth
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05170633's enrollment target sits among peer trials
140 23rd of 39 higher than 17 of 39 other Preterm Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preterm Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Transition From Donor Milk: a Feasibility Study
RECRUITING · NA
-
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
RECRUITING · NA
-
Stress Phenotypes and Preterm Birth
RECRUITING · NA
-
Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey
RECRUITING · NA
-
Bilateral Infant Stimulation Study
RECRUITING · NA
-
Effect of Support for Low-Income Mothers of Preterm Infants
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01419561 · 140 participants · Phase 2
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
- NCT01624805 · 140 participants · Phase 2
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome
- NCT02369770 · 140 participants · NA
Sensory-Motor Rehabilitation Post Stroke
- NCT02455193 · 140 participants · NA
Neuronal Effects of Exercise in Schizophrenia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI