Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04603547 · ClinicalTrials.gov registry record
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
A clinical trial of Neonatal Encephalopathy, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- 53
- Enrollment target
- 1
- Study location
NCT04603547: Active study of Neonatal Encephalopathy, sponsored by Brigham and Women's Hospital.
NCT04603547 is a study of Neonatal Encephalopathy that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 53 participants, below the 128-participant average among 6 other Neonatal Encephalopathy trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04603547, a study of Neonatal Encephalopathy, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or without respiratory support. Although, transcutaneous measurement of CO2 tension is the most commonly used non-invasive CO2 monitoring system in neonatal intensive care, to date tcPCO2 technique has not been evaluated systematically or used routinely in the intensive care of infants with neonatal encephalopathy receiving hypothermia treatment.
Primary Outcome
We will obtain both the measurement of transcutaneous carbon dioxide (tcPCO2) and PCO2 in neonates receiving therapeutic hypothermia. The agreement between the PCO2 and tcPCO2 values will be analyzed using Bland-Altman Plot, where the mean and standard deviation of differences between two measurements will be calculated.
Conditions Studied
Interventions
- DEVICE Transcutaneous Carbon Dioxide Monitoring
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-09-28 |
| Est. Completion | 2027-12-30 |
What the registry record for NCT04603547 still lists
NCT04603547 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 128-participant average among 6 other Neonatal Encephalopathy trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Neonatal Encephalopathy appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous Carbon Dioxide Monitoring is the first listed.
NCT04603547 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04603547 about?
NCT04603547 is a clinical study titled "Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy". The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or without respiratory support. Although, transcutaneous measurement of C...
What is the current status of trial NCT04603547?
This trial is currently active not recruiting. The enrollment target is 53 participants. The study started on 2019-09-28. Estimated completion is 2027-12-30.
What conditions does trial NCT04603547 study?
This clinical trial studies the following conditions: Neonatal Encephalopathy.
What interventions are being tested in trial NCT04603547?
The interventions under investigation include: Transcutaneous Carbon Dioxide Monitoring (DEVICE).
Who is sponsoring clinical trial NCT04603547?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04603547 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neonatal Encephalopathy
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.
-
Natural History Study of Patients with HPDL Mutations
RECRUITING
-
Healthy Little Eyes
RECRUITING
-
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
RECRUITING · Phase 2
-
Genetics of Neonatal Encephalopathy and Related Disorders
RECRUITING
-
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
RECRUITING
-
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
COMPLETED · 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
- NCT04177004 · 53 participants · Phase 1
Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
- NCT04199741 · 53 participants · Phase 1
PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
- NCT04835129 · 53 participants · Phase 2
Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
- NCT04913805 · 53 participants · Phase 2
Matching Perfusion and Metabolic Activity in HFpEF
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