Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus

NCT03551600 | Completed

• 1 other identifier: 83943
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 3

Brief 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 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

Keywords

Near-infrared spectroscopy (NIRS); renal oxygen saturations; splanchnic oxygen saturations

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Secondary Outcomes (1)

• Renal and splanchnic rSO2 measurements during feedings

  48 hours

Study Arms (4)

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

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

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

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

Procedure: Near-infrared spectroscopy (NIRS)

Interventions

Near-infrared spectroscopy (NIRS) PROCEDURE

NIRS analyzes regional oxygen saturations (rSO2)

>/= 34 week infants, CHD; >/= 34 wk infants, no CHD; Preterm, moderate to large PDA; Preterm, no PDA

Eligibility Criteria

• Age: 12 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm, Late preterm, and term infants

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Utah: lead
• Intermountain Health Care, Inc.: collaborator

Study Sites (3)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah Health

Salt Lake City, Utah, 84112, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Premature Birth; Heart Defects, Congenital; Ductus Arteriosus, Patent; Enterocolitis, Necrotizing

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mariana Baserga, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: October 1, 2015
• Primary Completion: February 9, 2022
• Study Completion: June 30, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)