Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy (NIRS/NICU2)
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|ClinicalTrials.gov Identifier: NCT02534090|
Recruitment Status : Unknown
Verified August 2015 by Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital.
Recruitment status was: Not yet recruiting
First Posted : August 27, 2015
Last Update Posted : August 27, 2015
Nowadays feeding intolerance (FI) is a common condition among preterm infants. It has been estimated that 16%-29% of premature infants admitted to neonatal intensive care units (NICUs) develop feeding intolerance at some point during their length of stay. The most frequent signs of FI are the presence of abdominal distension, abundant and/or bilious gastric residuals and vomiting suggesting an inability of the infant to further tolerate enteral nutrition, it increases with decreasing in gestational age (GA) and birth weight (BW). FI represents one of the most uncontrollable variables in the early nutritional management of these infants, and may lead to suboptimal nutrition, delayed attainment of full enteral feeding and prolonged parenteral nutrition supply.
NIRS has been used in preterm infants to evaluate changes in cerebral perfusion and oxygenation. It provides real time insight into the oxygen delivery, presented as regional oxygen saturation rSO2 with lower values than SpO2 distal pulse-oximetry where is mostly measured as arterialized capillary bed (around 55% vs 98% Oxygen saturation in regional NIRS vs conventional pulse-oximetry). Light easily penetrates the thin tissues of the neonate through bone and soft tissue, particularly the thin capillary bed of the tissues; NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.
This technique uses principles of optical spectrophotometry that make use of the fact that biological material, including the skull, is relatively transparent in the NIR range.
Dave et al. evaluated the abdominal tissue oxygenation with NIRS, and showed that preterm infants change their cerebral - splanchnic oxygenation ratios during feedings, mainly because an increasing in the splanchnic oxygenation.
Gay et al. performed abdominal NIRS in premature piglets showing association of perfusion/oxygen changes with NEC spectrum.
The investigators would like to evaluate the association between feeding intolerance and unchanged splanchnic regional saturation and variation in the cerebral splanchnic ratio.
FI diagnosis follows a subjective approach, where the clinician is worried in further risk of develop Necrotizing enterocolitis (NEC). This non-studied relationship (FI and NEC) lower the threshold for the diagnosis of FI. Furthermore, infants with FI diagnosis commonly are subject of stop or slow the progression of feedings, increasing the risk of intestinal villi atrophy, and increase the length of parenteral nutrition support, and also the length of stay in the NICU settings. If NIRS technology help the clinicians to detect true abnormalities objectively as a new monitor assessing adequate feeds progress decreasing failure to feed, and therefore diminishing the need for parenteral feeds and further complication associated with it.
|Condition or disease|
|Feeding Intolerance Necrotizing Enterocolitis Premature Infant|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||March 2016|
Feeding Intolerant Preterm Infants
32 weeks to 36 weeks 6 days old of post menstrual age infants, feeding intolerants monitored with INVOS device for rSO2
Feeding Tolerant Preterm Infants (Controls)
32 weeks to 36 weeks 6 days old of post menstrual age infants without problems through the enteral feedings.
- Low abdominal (Splanchnic) tissue oxygenation (less than 0.50 Oxygen saturation). [ Time Frame: 3 days ]There is not an specific threshold of regional oxygen saturation measured through NIRS, the investigators want to evaluate the range of saturation as follows: 1. Greater than 0.60; 2. .50 to .60 and less than 0.50 Oxygen saturation, reading above expected, expected, below expected respectively.
- Cerebral Splanchnic Ratio (CSOR) < 0.75 [ Time Frame: 3 days ]NIRS Cerebral Oxygenation and Splanchnic Oxygenation help to obtain an index where 0.75 to 0.95 could be considering adequate and below 0.75 considered abnormal. Area under the ROC curve is needed.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534090
|Contact: Ricardo Castillo-Galvan, MDemail@example.com|