Infant, Premature, DiseasesNCT01855347
Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy
An observational study of Infant, Premature, Diseases and Hypoxia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature infant population, principally those with associated risk like extreme prematurity, extreme low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia) and those born in hospitals with limited… Read more about this study
- Who is it for?
- Ages Up to 3 weeks
- Conditions the study is for
- Infant, Premature, Diseases, Hypoxia, Necrotizing Enterocolitis
- What is being tested?
- Near Infrared Spectroscopy
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jul 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants (Premature Infants) from 32 to 36 weeks of post menstrual age hospitalized in the Neonatal Intensive Care Unit (NICU) at Brigham and Women's Hospital.
Who may be able to join
- Preterm infant (32 to 36 weeks of postmenstrual age)
- Neonatal intensive care unit (NICU) patient
- Stable clinical condition (i.e. Vital signs, Hemodynamics)
- Age less than 6 weeks of life
Who cannot join
- Congenital Heart Disease
- Necrotizing enterocolitis prior to inclusion
- Non stable clinical condition
- Blood transfused less than three days prior to inclusion
- Abdominal injuries (i.e. Omphalocele, Gastroschisis, Skin irritation) that impedes placement of the optodes
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital Newborn Medicine Department
Boston, Massachusetts, 02215
Ricardo Castillo-Galvan, MD, 617-710-8995, rcastillo-galvan@partners.org
Steven A Ringer, MD, PhD
About this study
There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature infant population, principally those with associated risk like extreme prematurity, extreme low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia) and those born in hospitals with limited resources for optimal neonatal care.
Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen delivery.(3) In the premature patient population, many neurologic injuries occur as a result of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to validate NIRS measurements and have established normative data.(4-6) The non-invasive method of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care units in patients at risk for neurological injuries. This method has been successfully validated to monitor neonatal cerebral oxygenation in different clinical settings and study protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.
Read more
One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis. It is important to monitor not just cerebral perfusion but also the intestinal oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12); these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations in intestinal oxygenation and perfusion.
In summary, a-NIRS could be use in the premature infant population to define reference values, especially in patients at risk, which would then facilitate the early diagnosis of NEC spectrum diseases.
Read the detailed description
We will include, 10 premature infants from 32 to 36 weeks of post menstrual age, within the first week of life, that are clinically stable without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or having been transfused less than three days before the evaluation. Infants with abdominal injuries, omphalocele, gastroschisis and abdominal skin irritation that does not permit the application of the probes will also be excluded.
10 premature infants from 32 to 36 weeks of post menstrual age will be included, after their first week of life, clinically stable status, and without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or blood transfused less than three days before the moment of the evaluation. Infants with abdominal injuries, Omphalocele, Gastroschisis, skin irritation also will be excluded. NIRS device will record and monitor the Regional Oxygen Saturation (rSO2) in the infant during one week.
The evaluation will take place ar the Neonatal Intensive Care Unit (NICU), 6th floor at the Mary Horrigan Connors Center for Women's Health, Brigham and Women's Hospital. (http://www.brighamandwomens.org/newbornmedicine)
We will use a Near infrared spectroscopy (NIRS) device the INVOS 5100c (Covidien), catalogued under de Investigational Device Exemption (IDE) as 'non-significant risk device' (21 CFR 812.2) in order to perform monitoring as well as record-keeping with non-risk for the subject. No need Food and Drug Administration (FDA) clearance.
The application of the INVOS 5100c (Covidien) sensor optodes will be positioned in four locations (four channels), these will be in the lower abdomen, taking place bellow the umbilicus, with care, flush against the skin; in the submandibular region; upper left abdomen as well as in the thigh either left or right.
If the clinical status change during the monitoring, this could be discontinued under the criteria of the attending neonatologist in charge.
Once included, the sensors will be placed in the described areas and the team will reassure the quality of the lecture obtained. The rSO2 recordings will be continuously monitored for seven days, after this period of time, prospective observational following of patient data and outcomes will be implemented.
Clinical outcome data will be correlated with tissue oxygen saturation, other outcome variables will include length of NICU stay, morbidity, mortality, laboratory studies, oxygen saturation by standard pulse oximetry and continuous outcome variables will be analyzed using the Analysis of Variance (ANOVA) formula; mortality will be analyzed using Student's t-test. For the remaining variables (vital signs, lab values, oxygen saturation, morbidity, mortality), data will be extracted from clinical records and entered it into the electronic database.
The study staff, principal investigator, and co-investigators will identify potential subjects meeting the inclusion/exclusion criteria. Potential subjects will be identified by talking to the attending in charge at the NICU. Cases will be identified by communicating with the NIRS/NICU research team at Brigham and Women's Hospital.
Informed consent will be obtained from the parent(s) or guardian(s) under the Research involving no greater than minimal risk condition (46.404) where at least one of the parents must provide the permission.
In all cases we will approach the attending physician of prospective subjects to describe the study and obtain verbal consent to approach patients for recruitment; the attending physician or medical staff caring for the patient will be the first to make contact with the patients parents or guardian to describe the study briefly and ask permission for us to explain the study in more detail.
A review of the data will be conducted by a physician and a clinical review team. The principal investigator and study staff will be constantly monitoring and reviewing the rights, safety and welfare of all subjects in this trial through out the study.
In addition, the principal investigator will review any adverse events and report in accordance with the Partners Human Research Committees (PHRC) regulations.
- Being tested
- Near Infrared Spectroscopy
- Keywords
- Prematurity, Hypoxia, Necrotizing Enterocolitis, Near Infrared Spectroscopy, Abdominal tissue oxygenation, NICU
- Medical subject headings
- Infant, Premature, Diseases, Hypoxia, Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
Also called Near Infrared Spectroscopy (NIRS), NIRS Device, NIRS Monitor, INVOS 5100c
NIRS Monitoring with four channels regional areas of the preterm infant, such as: Submandibular, Periumbilical, Abdominal (Spleen region) and infant thigh.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Preterm infants (32 to 36 weeks of postmenstrual age) will be evaluated with a Near infrared Spectroscopy monitor device. Receives: Device: Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Tissue Oxygenation in Preterm Infant
Abdominal Tissue Oxygenation will be assessed with the Near Infrared Spectroscopy (NIRS) device, the INVOS 5100c with a time frame of one week in each of the participants, this device will monitor the oxygen tissue status in percentage unit. This outcome measure will be compare during this time frame and the underlying clinical status of the neonate. We then will look for an association between low percentages in the outcome measure and clinical evidences of Necrotizing Enterocolitis.
Measured: 5 days
Secondary outcomes (1)
Submandibular Tissue Oxygenation in Preterm Infant
Submandibular Tissue Oxygenation will be assessed with the INVOS 5100c NIRS device in real time along with the abdominal oxygenation (Primary outcome) and we will follow it principally during feedings.
It is also expressed in percentage.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startFeb 2016
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital
- Investigators
- Ricardo Castillo-Galvan, MD, Principal investigator, Brigham and Women's HospitalMaxwell Weinmann, MD, Study chair, Brigham and Women's HospitalSteven A Ringer, MD, PhD, Study director, Brigham and Women's HospitalEdward Kelly, MD, Study chair, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855347
- Sponsor's protocol ID
- BWH-NICU/NIRS
- Status last verified
- Aug 2015
- First submitted
- 14 May 2013
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16950321Pellicer 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.
PubMed 20580625Weiss M, Schulz G, Fasnacht M, Balmer C, Fischer JE, Gerber AC, Bucher HU, Baenziger O. Transcutaneously measured near-infrared spectroscopic liver tissue oxygenation does not correlate with hepatic venous oxygenation in children. Can J Anaesth. 2002 Oct;49(8):824-9. doi: 10.1007/BF03017416.
PubMed 12374712Wolf 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.
PubMed 19944837Patel 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.
PubMed 9432110Yoxall 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.
PubMed 7494653Dominguez KM, Moss RL. Necrotizing enterocolitis. Clin Perinatol. 2012 Jun;39(2):387-401. doi: 10.1016/j.clp.2012.04.011. Epub 2012 May 18.
PubMed 22682387Dave 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.
PubMed 19020529Gay 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.
PubMed 21683194Cortez 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.
PubMed 20828232
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT01855347
- Acronym / sponsor ID
- BWH-NICU/NIRS
- Keywords
- Prematurity, Hypoxia, Necrotizing Enterocolitis, Near Infrared Spectroscopy, Abdominal tissue oxygenation, NICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature infant population, principally those with associated risk like extreme prematurity, extreme low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia) and those born in hospitals with limited resources for optimal neonatal care.
Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen delivery.(3) In the premature patient population, many neurologic injuries occur as a result of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to validate NIRS measurements and have established normative data.(4-6) The non-invasive method of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care units in patients at risk for neurological injuries. This method has been successfully validated to monitor neonatal cerebral oxygenation in different clinical settings and study protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.
One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis. It is important to monitor not just cerebral perfusion but also the intestinal oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12); these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations in intestinal oxygenation and perfusion.
In summary, a-NIRS could be use in the premature infant population to define reference values, especially in patients at risk, which would then facilitate the early diagnosis of NEC spectrum diseases.
Detailed description
We will include, 10 premature infants from 32 to 36 weeks of post menstrual age, within the first week of life, that are clinically stable without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or having been transfused less than three days before the evaluation. Infants with abdominal injuries, omphalocele, gastroschisis and abdominal skin irritation that does not permit the application of the probes will also be excluded.
10 premature infants from 32 to 36 weeks of post menstrual age will be included, after their first week of life, clinically stable status, and without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or blood transfused less than three days before the moment of the evaluation. Infants with abdominal injuries, Omphalocele, Gastroschisis, skin irritation also will be excluded. NIRS device will record and monitor the Regional Oxygen Saturation (rSO2) in the infant during one week.
The evaluation will take place ar the Neonatal Intensive Care Unit (NICU), 6th floor at the Mary Horrigan Connors Center for Women's Health, Brigham and Women's Hospital. (http://www.brighamandwomens.org/newbornmedicine)
We will use a Near infrared spectroscopy (NIRS) device the INVOS 5100c (Covidien), catalogued under de Investigational Device Exemption (IDE) as 'non-significant risk device' (21 CFR 812.2) in order to perform monitoring as well as record-keeping with non-risk for the subject. No need Food and Drug Administration (FDA) clearance.
The application of the INVOS 5100c (Covidien) sensor optodes will be positioned in four locations (four channels), these will be in the lower abdomen, taking place bellow the umbilicus, with care, flush against the skin; in the submandibular region; upper left abdomen as well as in the thigh either left or right.
If the clinical status change during the monitoring, this could be discontinued under the criteria of the attending neonatologist in charge.
Once included, the sensors will be placed in the described areas and the team will reassure the quality of the lecture obtained. The rSO2 recordings will be continuously monitored for seven days, after this period of time, prospective observational following of patient data and outcomes will be implemented.
Clinical outcome data will be correlated with tissue oxygen saturation, other outcome variables will include length of NICU stay, morbidity, mortality, laboratory studies, oxygen saturation by standard pulse oximetry and continuous outcome variables will be analyzed using the Analysis of Variance (ANOVA) formula; mortality will be analyzed using Student's t-test. For the remaining variables (vital signs, lab values, oxygen saturation, morbidity, mortality), data will be extracted from clinical records and entered it into the electronic database.
The study staff, principal investigator, and co-investigators will identify potential subjects meeting the inclusion/exclusion criteria. Potential subjects will be identified by talking to the attending in charge at the NICU. Cases will be identified by communicating with the NIRS/NICU research team at Brigham and Women's Hospital.
Informed consent will be obtained from the parent(s) or guardian(s) under the Research involving no greater than minimal risk condition (46.404) where at least one of the parents must provide the permission.
In all cases we will approach the attending physician of prospective subjects to describe the study and obtain verbal consent to approach patients for recruitment; the attending physician or medical staff caring for the patient will be the first to make contact with the patients parents or guardian to describe the study briefly and ask permission for us to explain the study in more detail.
A review of the data will be conducted by a physician and a clinical review team. The principal investigator and study staff will be constantly monitoring and reviewing the rights, safety and welfare of all subjects in this trial through out the study.
In addition, the principal investigator will review any adverse events and report in accordance with the Partners Human Research Committees (PHRC) regulations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Device: Near Infrared SpectroscopyPreterm infants (32 to 36 weeks of postmenstrual age) will be evaluated with a Near infrared Spectroscopy monitor device. |
Who may qualify
- Ages
- Up to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants (Premature Infants) from 32 to 36 weeks of post menstrual age hospitalized in the Neonatal Intensive Care Unit (NICU) at Brigham and Women's Hospital.
Key inclusion criteria (4 listed)
- Preterm infant (32 to 36 weeks of postmenstrual age)
- Neonatal intensive care unit (NICU) patient
- Stable clinical condition (i.e. Vital signs, Hemodynamics)
- Age less than 6 weeks of life
Key exclusion criteria (5 listed)
- Congenital Heart Disease
- Necrotizing enterocolitis prior to inclusion
- Non stable clinical condition
- Blood transfused less than three days prior to inclusion
- Abdominal injuries (i.e. Omphalocele, Gastroschisis, Skin irritation) that impedes placement of the optodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared SpectroscopyAlso: Near Infrared Spectroscopy (NIRS), NIRS Device, NIRS Monitor, INVOS 5100cNIRS Monitoring with four channels regional areas of the preterm infant, such as: Submandibular, Periumbilical, Abdominal (Spleen region) and infant thigh. | Device | Preterm infants |
Primary outcome
Abdominal Tissue Oxygenation in Preterm Infant
Time frame: 5 days
Abdominal Tissue Oxygenation will be assessed with the Near Infrared Spectroscopy (NIRS) device, the INVOS 5100c with a time frame of one week in each of the participants, this device will monitor the oxygen tissue status in percentage unit. This outcome measure will be compare during this time frame and the underlying clinical status of the neonate. We then will look for an association between low percentages in the outcome measure and clinical evidences of Necrotizing Enterocolitis.
1 secondary outcome
Submandibular Tissue Oxygenation in Preterm Infant
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Background: PubMed 16950321Wolfberg 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.
- Background: PubMed 20580625Pellicer 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.
- Background: PubMed 12374712Weiss M, Schulz G, Fasnacht M, Balmer C, Fischer JE, Gerber AC, Bucher HU, Baenziger O. Transcutaneously measured near-infrared spectroscopic liver tissue oxygenation does not correlate with hepatic venous oxygenation in children. Can J Anaesth. 2002 Oct;49(8):824-9. doi: 10.1007/BF03017416.
- Background: PubMed 19944837Wolf 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.
- Background: PubMed 9432110Patel 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.
- Background: PubMed 7494653Yoxall 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.
- Background: PubMed 22682387Dominguez KM, Moss RL. Necrotizing enterocolitis. Clin Perinatol. 2012 Jun;39(2):387-401. doi: 10.1016/j.clp.2012.04.011. Epub 2012 May 18.
- Background: PubMed 19020529Dave 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.
- Background: PubMed 21683194Gay 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.
- Background: PubMed 20828232Cortez 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.
- Premature infants (Medline)Link provided by the sponsor.
- Necrotizing Enterocolitis (NIH)Link provided by the sponsor.
- Preterm labor and birth (NIH)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Castillo-Galvan, MD principal investigator
Brigham and Women's Hospital
Maxwell Weinmann, MD study chair
Brigham and Women's Hospital
Steven A Ringer, MD, PhD study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases and Hypoxia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Castillo-Galvan, MD (6177108995, rcastillo-galvan@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Tissue Oxygenation in Preterm Infant (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855347, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.