Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy

NCT02534090 | Unknown

• 1 other identifier: 2015P001806
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Feeding Intolerance; Necrotizing Enterocolitis; Premature Infant

Keywords

Premature; Preterm; Necrotizing; Enterocolitis; NIRS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cerebral Splanchnic Ratio (CSOR) < 0.75

  3 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants from 32 weeks to 36 weeks 6 days of post menstrual age.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (13)

• 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.

  PMID: 20007987 BACKGROUND

• 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.

  PMID: 24934405 RESULT

• 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.

  PMID: 23962482 RESULT

• Wolfberg AJ, du Plessis AJ. Near-infrared spectroscopy in the fetus and neonate. Clin Perinatol. 2006 Sep;33(3):707-28, viii. doi: 10.1016/j.clp.2006.06.010.

  PMID: 16950321 RESULT

• 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.

  PMID: 20580625 RESULT

• 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.

  PMID: 19944837 RESULT

• 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. doi: 10.1203/00006450-199801000-00006.

  PMID: 9432110 RESULT

• 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. doi: 10.1203/00006450-199509000-00008.

  PMID: 7494653 RESULT

• Pellicer A, Gaya F, Madero R, Quero J, Cabanas F. Noninvasive continuous monitoring of the effects of head position on brain hemodynamics in ventilated infants. Pediatrics. 2002 Mar;109(3):434-40. doi: 10.1542/peds.109.3.434.

  PMID: 11875138 RESULT

• 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. doi: 10.1038/jp.2008.189. Epub 2008 Nov 20.

  PMID: 19020529 RESULT

• 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 piglets. J Pediatr Surg. 2011 Jun;46(6):1034-40. doi: 10.1016/j.jpedsurg.2011.03.025.

  PMID: 21683194 RESULT

• 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. Epub 2010 Sep 9.

  PMID: 20828232 RESULT

• 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(6):652-6. doi: 10.1097/MPG.0b013e318287e9d7.

  PMID: 23343937 RESULT

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth; Enterocolitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Ricardo Castillo-Galvan, MD

CONTACT

6177108995; rcastillo-galvan@bwh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Newborn Medicine Department

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 27, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 27, 2015

Record last verified: 2015-08