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

  • STATUS
    Recruiting
  • days left to enroll
    2
  • participants needed
    70
  • sponsor
    University of Utah
Updated on 4 March 2022
sepsis
enteral feeding
heart failure
ischemia
respiratory distress
cardiac surgery
heart surgery
premature birth
prematurity
prostaglandin
very low birth weight
renal perfusion
congenital heart disease
single ventricle
vasopressors
near-infrared spectroscopy
necrotizing enterocolitis
patent ductus arteriosus
congenital heart defects
preterm birth
hypoplastic left heart syndrome
extubated
gavage

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.

Details
Condition Infant, Premature, Congenital Heart Disease, Patent Ductus Arteriosus, Necrotizing Enterocolitis
Treatment Near-Infrared Spectroscopy (NIRS)
Clinical Study IdentifierNCT03551600
SponsorUniversity of Utah
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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)

Exclusion Criteria

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)
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