Necrotizing Enterocolitis Clinical Trial
— NIRS/NICU2Official title:
Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy
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.
Innovation:
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: - Premature infants from 32 to 36 6/7 weeks of postmenstrual age, with feeding tolerance at least of 50ml/kg/day which have been diagnosed with food intolerance. - Control group will be composed with patients from the same population age range tolerating at least 50 ml/Kg/day (Half of the minimum full feeds daily requirement) of Human milk of enteral Formula delivered in bolus, 6 to 8 times per day. - Written informed consent from parent(s) or guardian. Exclusion Criteria: - Premature infants with know conditions that could affect the attachment of the sensors in the body areas as Gastroschisis, Omphalocele, Post surgical intestine resection, on peritoneal dialysis, with lacerations in the abdomen and frontal area of the head. - Infants who have been diagnosed with Necrotizing enterocolitis. - Infants with current diagnosis of Sepsis and/or Systemic Inflammatory Response Syndrome (SIRS). - Infants with severe Intra-Ventricular Hemorrhage (Intra-cranial Hemorrhage). Infants with Hereditary Spherocytosis, total or partial (hypoplasia) congenital asplenia hypoplasia. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Brigham and Women's Hospital |
Cortez J, Gupta M, Amaram A, Pizzino J, Sawhney M, Sood BG. Noninvasive evaluation of splanchnic tissue oxygenation using near-infrared spectroscopy in preterm neonates. J Matern Fetal Neonatal Med. 2011 Apr;24(4):574-82. doi: 10.3109/14767058.2010.511335 — View Citation
Dani C, Corsini I, Generoso M, Gozzini E, Bianconi T, Pratesi S. Splanchnic Tissue Oxygenation for Predicting Feeding Tolerance in Preterm Infants. JPEN J Parenter Enteral Nutr. 2015 Nov;39(8):935-40. doi: 10.1177/0148607114538671. Epub 2014 Jun 16. — View Citation
Dani C, Pratesi S, Barp J, Bertini G, Gozzini E, Mele L, Parrini L. Near-infrared spectroscopy measurements of splanchnic tissue oxygenation during continuous versus intermittent feeding method in preterm infants. J Pediatr Gastroenterol Nutr. 2013 Jun;56 — View Citation
Dave V, Brion LP, Campbell DE, Scheiner M, Raab C, Nafday SM. Splanchnic tissue oxygenation, but not brain tissue oxygenation, increases after feeds in stable preterm neonates tolerating full bolus orogastric feeding. J Perinatol. 2009 Mar;29(3):213-8. do — View Citation
Fanaro S. Feeding intolerance in the preterm infant. Early Hum Dev. 2013 Oct;89 Suppl 2:S13-20. doi: 10.1016/j.earlhumdev.2013.07.013. Epub 2013 Aug 17. Review. — View Citation
Gay AN, Lazar DA, Stoll B, Naik-Mathuria B, Mushin OP, Rodriguez MA, Burrin DG, Olutoye OO. Near-infrared spectroscopy measurement of abdominal tissue oxygenation is a useful indicator of intestinal blood flow and necrotizing enterocolitis in premature pi — View Citation
Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299. Review. — View Citation
Patel J, Marks K, Roberts I, Azzopardi D, Edwards AD. Measurement of cerebral blood flow in newborn infants using near infrared spectroscopy with indocyanine green. Pediatr Res. 1998 Jan;43(1):34-9. — View Citation
Pellicer A, Bravo Mdel C. Near-infrared spectroscopy: a methodology-focused review. Semin Fetal Neonatal Med. 2011 Feb;16(1):42-9. doi: 10.1016/j.siny.2010.05.003. Epub 2010 Jun 26. Review. — View Citation
Pellicer A, Gayá F, Madero R, Quero J, Cabañas F. Noninvasive continuous monitoring of the effects of head position on brain hemodynamics in ventilated infants. Pediatrics. 2002 Mar;109(3):434-40. — View Citation
Wolf M, Greisen G. Advances in near-infrared spectroscopy to study the brain of the preterm and term neonate. Clin Perinatol. 2009 Dec;36(4):807-34, vi. doi: 10.1016/j.clp.2009.07.007. Review. — View Citation
Wolfberg AJ, du Plessis AJ. Near-infrared spectroscopy in the fetus and neonate. Clin Perinatol. 2006 Sep;33(3):707-28, viii. Review. — View Citation
Yoxall CW, Weindling AM, Dawani NH, Peart I. Measurement of cerebral venous oxyhemoglobin saturation in children by near-infrared spectroscopy and partial jugular venous occlusion. Pediatr Res. 1995 Sep;38(3):319-23. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low abdominal (Splanchnic) tissue oxygenation (less than 0.50 Oxygen saturation). | 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. | 3 days | No |
Secondary | Cerebral Splanchnic Ratio (CSOR) < 0.75 | 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. | 3 days | No |
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