Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combining Restrictive Guidelines and a NIRS SCORE to Decrease RBC Transfusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02535208
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

The primary aim of this study is to determine the mean number of red blood cell (RBC) transfusions received by preterm infants cared for using restrictive Hgb guidelines in combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the mean number of transfusions received by preterm infants cared for using liberal guidelines alone.

This study is designed as a prospective randomized controlled trial. Preterm infants less than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled into the study during day of life 0 to 3. Study participants will be randomly assigned into two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal group, RBC transfusions will be given to subjects when their Hgb level falls below defined values that are based on respiratory support status. In the restrictive group, RBC transfusions will be given to subjects either when their Hgb level falls below defined values based on respiratory status or, despite not having reached their Hgb trigger threshold, if they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a near-infrared spectroscopy (NIRS) evaluation that demonstrates an SCOR < 0.73.


Condition or disease Intervention/treatment Phase
Anemia of Prematurity (AOP) Other: Restrictive transfusions based on SCOR assessment Other: Liberal transfusions Not Applicable

Detailed Description:

Previous studies have demonstrated that premature infants transfused using restrictive guidelines, in which red blood cell (RBC) transfusions are triggered at relatively low Hgb thresholds, receive significantly fewer transfusions and have similar clinical outcomes to premature infants transfused using liberal transfusion guidelines that use higher Hgb thresholds. However, some remain apprehensive about a restrictive transfusion approach, primarily because the research remains somewhat limited. In addition, concern also exists because some previous researchers found that although there was no difference in mortality based on whether a restrictive or liberal transfusion guideline was used, they did find that a liberal transfusion policy may provide a neuro-protective benefit. This then implies that there may be circumstances in which a neonate transfused with a restrictive strategy could benefit from an increased Hgb level, but does not receive transfusion because their Hgb has not dropped below a predefined transfusion trigger level.

The investigators have previously demonstrated in an observational study that measuring tissue oxygen saturation (rSO2) levels using near-infrared spectroscopy (NIRS) can be more specific in determining RBC transfusion needs in the preterm population than relying on Hgb values derived from a blood sample. Using a model to calculate the splanchnic to cerebral oxygenation ratio (SCOR) [splanchnic rSO2 / cerebral rSO2] could predict with a high probability if preterm infants would improve clinically after a RBC transfusion. Infants with a low SCOR, who were in a physiologic state in which blood and oxygen were being diverted away from the gastrointestinal tract, usually benefited after transfusion. Neonates with a high SCOR, in which oxygen saturation in gut tissue was relatively constant with brain tissue, were unlikely to improve with transfusion.

The intent of this study is to determine whether the SCOR assessment (performed in addition to traditional measurement of Hbg) can better predict which premature infants will benefit from RBC transfusion in a subset of infants demonstrating signs of anemia before having reached the transfusion threshold of a restrictive transfusion protocol. The goal is to assess whether this additional assessment of oxygen delivery (SCOR) can safely reduce the rate of transfusion in a group of subjects treated on a restrictive protocol compared with those transfused using a liberal transfusion protocol. The hypothesis is that by incorporating a measure of transfusion need, SCOR, to the clinical management of a group of preterm infants following a restrictive guideline approach, we can still reduce the average number of transfusions that these infants receive compared to a similar group of preterm infants managed with a liberal approach, yet have no difference in morbidity, including neurological outcomes.

This study is designed as a prospective randomized controlled trial. Preterm infants less than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled into the study during day of life 0 to 3. Study participants will be randomly assigned into two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal group, RBC transfusions will be given to subjects when their Hgb level falls below defined values that are based on respiratory support status. In the restrictive group, RBC transfusions will be given to subjects either when their Hgb level falls below defined values based on respiratory status or, despite not having reached their Hgb trigger threshold, if they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a near-infrared spectroscopy (NIRS) evaluation that demonstrates an SCOR < 0.73.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Pilot Randomized Trial of Restrictive Red Blood Cell Transfusion Guidelines Used in Combination With Near-infrared Spectroscopy Splanchnic-cerebral Oxygenation Ratio Evaluations Versus Liberal Red Blood Cell Transfusion Guidelines in Preterm Infants
Actual Study Start Date : May 16, 2016
Actual Primary Completion Date : October 3, 2018
Actual Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Restrictive transfusion group Other: Restrictive transfusions based on SCOR assessment
RBC transfusions will be given to subjects either when participants' Hgb levels fall below defined values based on respiratory status or, despite not having reached their Hgb trigger threshold, if they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a NIRS evaluation that demonstrates an SCOR < 0.73.

Active Comparator: Liberal transfusion group Other: Liberal transfusions
In the liberal group, RBC transfusions will be given to participants when their Hgb level falls below defined values that are based on respiratory support status, as is standard practice.




Primary Outcome Measures :
  1. Average number of RBC transfusions received during neonatal intensive care unit (NICU) stay [ Time Frame: Throughout the duration of NICU stay (around 3 months, varies based on infant's overall health) ]

Secondary Outcome Measures :
  1. Presence of common morbidities of prematurity [ Time Frame: Throughout the duration of NICU stay (around 3 months, varies based on infant's overall health) ]
    Common morbidities to be assessed are: Intraventricular hemorrhage (IVH), Periventricular leukomalacia (PVL), Retinopathy of prematurity (ROP), Bronchopulmonary Dysplasia (BPD), and Necrotizing Enterocolitis (NEC)

  2. Difference in growth (weight) between the two groups at various timepoints [ Time Frame: At time of NICU dischare (about 3 months), and every 6 months for 3 years ]
    Investigators will measure differences in both short term and long term physical growth parameters (weight) based upon NICU discharge and return examinations at our NICU follow-up clinic which normally occur every 6 months after discharge for up to 3 years of age.

  3. Difference in growth (length) between the two groups at various timepoints [ Time Frame: At time of NICU discharge (about 3 months), and every 6 months for 3 years ]
    Investigators will measure differences in both short term and long term physical growth parameters (length) based upon NICU discharge and return examinations at our NICU follow-up clinic which normally occur every 6 months after discharge for up to 3 years of age.

  4. Difference in growth (head circumference) between the two groups at various timepoints [ Time Frame: At time of NICU discharge (about 3 months), and every 6 months for 3 years ]
    Investigators will measure differences in both short term and long term physical growth parameters (head circumference) based upon NICU discharge and return examinations at our NICU follow-up clinic which normally occur every 6 months after discharge for up to 3 years of age.

  5. Difference in development between the two groups [ Time Frame: When participant reaches 2 years of age ]
    Developmental outcome will be assessed using the Mullen Scales of Early Learning Test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inborn patients (NYULMC and Bellevue Hospital) less than or equal to 30 weeks gestational age
  • Less than 1250 grams
  • Less than 72 hours old at time of parental consent and study inclusion

Exclusion Criteria:

  • Preterm neonates with 5 minute Apgar score < 3, 10 minute Apgar score < 5, congenital heart disease, alloimmune hemolytic disease, known chromosomal abnormalities, or major malformations will be excluded.
  • Preterm neonates with a birth weight of less than 500 grams will also be excluded
  • Any patient already diagnosed with intraventricular hemorrhage (IVH), hydrocephalus or a surgical condition prior to recruitment into the study will be excluded.
  • Patients receiving high-frequency ventilation at the time of recruitment will be excluded.
  • Any preterm infant who has already received > 2 RBC transfusions prior to enrollment will be excluded.

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): NCT02535208


Locations
Layout table for location information
United States, New York
Bellevue Hospital Center
New York, New York, United States, 10016
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Sean M Bailey, MD NYU MEDICAL CENTER

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02535208     History of Changes
Other Study ID Numbers: 14-01514
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications