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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
Sponsor:
Information provided by (Responsible Party):
Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital

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.


Condition or disease
Feeding Intolerance Necrotizing Enterocolitis Premature Infant

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Premature infants from 32 weeks to 36 weeks 6 days of post menstrual age.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534090


Contacts
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Contact: Ricardo Castillo-Galvan, MD 6177108995 rcastillo-galvan@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital

Publications of Results:

Other Publications:
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Responsible Party: Ricardo Castillo-Galvan, MD, Newborn Medicine Department, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02534090    
Other Study ID Numbers: 2015P001806
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital:
Premature
Preterm
Necrotizing
Enterocolitis
NIRS
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases