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NCT03551600 · ClinicalTrials.gov registry record
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
A clinical trial of Congenital Heart Disease and Infant, Premature, sponsored by University of Utah.
- Completed
- Registry status
- 64
- Enrollment target
- 3
- Study locations
NCT03551600 is a study of Congenital Heart Disease and Infant, Premature that has completed, run by University of Utah. The registered enrollment target is 64 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT03551600, a study of Congenital Heart Disease and Infant, Premature, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- 64 participants
- Enrollment target
- 3
- Study locations
Study Summary
Patent ductus arteriosus (PDA) is a common problem in the neonatal intensive care unit and can be secondary to prematurity or congenital heart disease (CHD). PDA is the most common cardiovascular abnormality in preterm infants, and is seen in 55% of infants born at 28 weeks, and 1000 grams or less. In addition to producing heart failure and prolonged respiratory distress or ventilator dependence, PDA has been implicated in development of broncho-pulmonary dysplasia, interventricular hemorrhage, cerebral ischemia, and necrotizing enterocolitis (NEC). In an Israeli population study 5.6% of all very low birth weight infants (VLBW) were diagnosed with NEC, and 9.4% of VLBW infants with PDA were found to have NEC. In a retrospective analysis of neonates with CHD exposed to Prostaglandin E found that the odds of developing NEC increased in infants with single ventricle physiology, especially hypoplastic left heart syndrome. The proposed pathophysiological explanation of NEC and PDA is a result of "diastolic steal" where blood flows in reverse from the mesenteric arteries back into the aorta leading to compromised diastolic blood flow and intestinal hypo-perfusion. Prior studies have demonstrated that infants with a hemodynamically significant PDA have decreased diastolic flow velocity of the mesenteric and renal arteries when measured by Doppler ultrasound, and an attenuated intestinal blood flow response to feedings in the post prandial period compared to infants without PDA. Near Infrared Spectroscopy (NIRS) has also been used to assess regional oxygen saturations (rSO2) in tissues such as the brain, kidney and mesentery in premature infants with PDA. These studies demonstrated lower baseline oxygenation of these tissues in infants with hemodynamically significant PDA. These prior NIRS studies evaluated babies with a median gestational age at the time of study of 10 days or less. It is unknown if this alteration in saturations will persist in extubated neonates with PDA
Conditions Studied
Interventions
- PROCEDURE Near-infrared spectroscopy (NIRS)
Study Locations (3)
Utah
- Intermountain Medical Center - Murray
- University of Utah Health - Salt Lake City
- Primary Children's Hospital - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2015-10 |
| Est. Completion | 2022-06-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03551600
The ClinicalTrials.gov registry entry for NCT03551600 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (86% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Near-infrared spectroscopy (NIRS) is the first listed.
NCT03551600 reports 3 study locations spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT03551600 about?
NCT03551600 is a clinical study titled "Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus". Patent ductus arteriosus (PDA) is a common problem in the neonatal intensive care unit and can be secondary to prematurity or congenital heart disease (CHD). PDA is the most common cardiovascular abnormality in preterm infants, and is seen in 55% of infants born at 28 weeks, and 1000 grams or less. ...
What is the current status of trial NCT03551600?
This trial is currently completed. The enrollment target is 64 participants. The study started on 2015-10. Estimated completion is 2022-06-30.
What conditions does trial NCT03551600 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Infant, Premature, Necrotizing Enterocolitis, Patent Ductus Arteriosus.
What interventions are being tested in trial NCT03551600?
The interventions under investigation include: Near-infrared spectroscopy (NIRS) (PROCEDURE).
Who is sponsoring clinical trial NCT03551600?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03551600 being conducted?
This trial has 3 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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