Infant, PrematureNCT03551600
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
An observational study of Infant, Premature and Congenital Heart Disease, run by University of Utah at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 days to 6 months
- Conditions the study is for
- Infant, Premature, Congenital Heart Disease, Patent Ductus Arteriosus
- What is being tested?
- Near-infrared spectroscopy (NIRS)
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2015to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 days to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm, Late preterm, and term infants
Who may be able to join
- PDA secondary to prematurity
- Premature infants of ≤ 32 weeks gestational age at birth
- Patent ductus arteriosus diagnosed via echocardiogram
- Feeding volume ≥ 70 ml/kg/day
- Stable Clinical Condition (no vasopressors, no clinical sepsis)
- Age ≥ 12 days of life
Show all 26Show fewer
- Control group
- Premature infants of ≤ 32 weeks gestational age at birth
- No PDA
- Feeding volume ≥ 70 ml/kg/day
- Stable Clinical Condition (no vasopressors, no clinical sepsis)
- Age ≥ 12 days of life
- PDA secondary to CHD and Prostaglandin E (PGE)
- Infants of ≥ 32 weeks gestational age at birth
- Ductal dependant congenital heart disease
- PGE infusion
- No prior cardiac surgery
- Any bolus feedings 10 ml/kg/day or more
- Stable Clinical Condition (no vasopressors, no clinical sepsis)
- Age ≥ 12 days of life
- Control Group
- Infants of ≥ 32 weeks gestational age at birth
- No know congenital heart defect including PDA.
- No prior cardiac surgery
- Feeding volume ≥ 1/2 of total fluid volume ~50- 70 ml/kg/day
- Stable Clinical Condition (no vasopressors, no clinical sepsis)
Who cannot join
- Lack of parental consent
- Multiple congenital anomalies
- Unstable clinical condition
- Prior abdominal pathology (medical/surgical necrotizing enterocolitis within the last 14 days, gastroschisis, or other abdominal abnormality)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Intermountain Medical Center
Murray, Utah, 84107
University of Utah Health
Salt Lake City, Utah, 84112
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
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 at 12 or more days of life on full enteral feedings.
In the present study the investigators hypothesize that infants with a PDA, whether secondary to prematurity or ductal dependent CHD, will have decreased splanchnic and renal perfusion and rSO2 renal/splanchnic measurements will be decreased during times of increased metabolic demand such as enteral gavage feeding. To test this hypothesis the investigators have designed a prospective observational study utilizing NIRS to record regional saturations at baseline, during feedings, and after feedings for 48 hours.
- Conditions
- Infant, Premature, Congenital Heart Disease, Patent Ductus Arteriosus, Necrotizing Enterocolitis
- Being tested
- Near-infrared spectroscopy (NIRS)
- Keywords
- Near-infrared spectroscopy (NIRS), renal oxygen saturations, splanchnic oxygen saturations
- Medical subject headings
- Premature Birth, Heart Defects, Congenital, Ductus Arteriosus, Patent, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopy (NIRS)Procedure or surgery
NIRS analyzes regional oxygen saturations (rSO2)
| Study group | Role | What they receive |
|---|---|---|
| Preterm, no PDA | Babies </= 32 weeks gestation at birth with no symptoms of a patent ductus arteriosus (PDA) or echocardiogram confirmation of no PDA
Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic and cranial regions, minimum of 8 feedings need to be recorded Receives: Procedure: Near-infrared spectroscopy (NIRS) | |
| Preterm, moderate to large PDA | Babies </= 32 weeks gestation at birth with confirmed moderate to large PDA on echocardiogram Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic and cranial regions, minimum of 8 feedings need to be recorded Receives: Procedure: Near-infrared spectroscopy (NIRS) | |
| >/= 34 wk infants, no CHD | Babies >/= to 34 weeks gestation at birth with no evidence of ductal dependent congenital heart disease (CHD)
Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic, renal and cranial regions, minimum of 8 feedings need to be recorded Receives: Procedure: Near-infrared spectroscopy (NIRS) | |
| >/= 34 week infants, CHD | Babies >/= to 34 weeks gestation at birth with ductal dependent CHD
Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic, renal and cranial regions, minimum of 8 feedings need to be recorded Receives: Procedure: Near-infrared spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline renal and splanchnic rSO2 measurements
Compare the baseline renal and splanchnic rSO2 measurements between preterm, late preterm, and term infants with a patent ductus arteriosus to those infants without a patent ductus arteriosus
Measured: 48 hours
Secondary outcomes (1)
Renal and splanchnic rSO2 measurements during feedings
Compare the renal and splanchnic rSO2 measurements between preterm, late preterm, and term infants with a patent ductus arteriosus to those infants without a patent ductus arteriosus immediately before, during, and after feedings
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study startOct 2015
- Primary completion9 Feb 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Responsible party
- Principal investigator, Mariana Baserga, University of Utah
- Investigators
- Mariana Baserga, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551600
- Sponsor's protocol ID
- 83943
- Status last verified
- Apr 2023
- First submitted
- 29 May 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
- ClinicalTrials.gov ID
- NCT03551600
- Acronym / sponsor ID
- 83943
- Conditions
- Infant, Premature, Congenital Heart Disease, Patent Ductus Arteriosus, Necrotizing Enterocolitis
- Keywords
- Near-infrared spectroscopy (NIRS), renal oxygen saturations, splanchnic oxygen saturations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Study start
- Oct 2015 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 at 12 or more days of life on full enteral feedings.
In the present study the investigators hypothesize that infants with a PDA, whether secondary to prematurity or ductal dependent CHD, will have decreased splanchnic and renal perfusion and rSO2 renal/splanchnic measurements will be decreased during times of increased metabolic demand such as enteral gavage feeding. To test this hypothesis the investigators have designed a prospective observational study utilizing NIRS to record regional saturations at baseline, during feedings, and after feedings for 48 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm, no PDA | – | Procedure: Near-infrared spectroscopy (NIRS)Babies </= 32 weeks gestation at birth with no symptoms of a patent ductus arteriosus (PDA) or echocardiogram confirmation of no PDA Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic and cranial regions, minimum of 8 feedings need to be recorded |
| Preterm, moderate to large PDA | – | Procedure: Near-infrared spectroscopy (NIRS)Babies </= 32 weeks gestation at birth with confirmed moderate to large PDA on echocardiogram Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic and cranial regions, minimum of 8 feedings need to be recorded |
| >/= 34 wk infants, no CHD | – | Procedure: Near-infrared spectroscopy (NIRS)Babies >/= to 34 weeks gestation at birth with no evidence of ductal dependent congenital heart disease (CHD) Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic, renal and cranial regions, minimum of 8 feedings need to be recorded |
| >/= 34 week infants, CHD | – | Procedure: Near-infrared spectroscopy (NIRS)Babies >/= to 34 weeks gestation at birth with ductal dependent CHD Near-infrared spectroscopy (NIRS) monitoring x 48 hours of splanchnic, renal and cranial regions, minimum of 8 feedings need to be recorded |
Who may qualify
- Ages
- 12 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm, Late preterm, and term infants
Key inclusion criteria (26 listed)
- PDA secondary to prematurity
- Control group
- Premature infants of ≤ 32 weeks gestational age at birth
- No PDA
- Feeding volume ≥ 70 ml/kg/day
Key exclusion criteria (4 listed)
- Lack of parental consent
- Multiple congenital anomalies
- Unstable clinical condition
- Prior abdominal pathology (medical/surgical necrotizing enterocolitis within the last 14 days, gastroschisis, or other abdominal abnormality)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-infrared spectroscopy (NIRS)NIRS analyzes regional oxygen saturations (rSO2) | Procedure or surgery | >/= 34 week infants, CHD, >/= 34 wk infants, no CHD, Preterm, moderate to large PDA, Preterm, no PDA |
Primary outcome
Baseline renal and splanchnic rSO2 measurements
Time frame: 48 hours
Compare the baseline renal and splanchnic rSO2 measurements between preterm, late preterm, and term infants with a patent ductus arteriosus to those infants without a patent ductus arteriosus
1 secondary outcome
Renal and splanchnic rSO2 measurements during feedings
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Baserga, MD principal investigator
University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature and Congenital Heart Disease, run by University of Utah at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline renal and splanchnic rSO2 measurements (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.