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Saturation Targets and Resuscitation in Preterm Trial (STARTPreterm)

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: NCT03115463
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
American Academy of Pediatrics
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this research project is to determine if use of optimized target oxygen strategy during delivery room resuscitation can reduce oxidative stress in premature newborns. Objective is to compare oxidative stress markers between preterm neonates resuscitated in the delivery room using three different target oxygen strategies. OX50 target oxygen strategy is currently in use and recommended by neonatal resuscitation program. In this strategy oxygen is adjusted to meet the goal transitional saturations which are approximated 50th centile saturations observed in healthy term newborns. In OX25 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 25th percentile transitional saturations observed in healthy term newborns. In OX75 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 75th percentile transitional saturations observed in healthy term newborns.

Condition or disease Intervention/treatment Phase
Oxidative Stress Other: Titration of oxygen during neonatal resuscitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Clinical care team in the neonatal intensive care unit, investigators running the oxidative stress measurements and investigator assessing neurodevelopmental outcomes will be blinded to which arm the infant was randomized to in the delivery room.
Primary Purpose: Treatment
Official Title: Saturation Targets and Resuscitation in Preterm Infants the Delivery Room: A Randomized Controlled Trial
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: OX25
Resuscitation will be initiated at 30% O2. Titration of oxygen during neonatal resuscitation: Intervention is target goal saturations which will be the 10th to 25th percentile saturations observed in healthy term newborns.
Other: Titration of oxygen during neonatal resuscitation
Resuscitation will be initiated at 30% O2 and target goal saturations will be the 10th to 25th percentile saturations in OX25 and 75th percentile in OX75 group. The control group will be resuscitated with the OX50 strategy in which resuscitation will be initiated with 30% O2 and target goal saturations will be the approximated median SpO2 observed in healthy term newborns as per current NRP guidelines. For the first 6 minutes after birth, target ranges of of all 3 arms are different. After 6 min, the target ranges are are identical.

No Intervention: OX50
Resuscitation will be initiated with 30% O2 and target goal saturations will be the approximated median SpO2 observed in healthy term newborns as per current NRP guidelines
Active Comparator: OX75
Resuscitation will be initiated at 30% O2. Titration of oxygen during neonatal resuscitation: Intervention is target goal saturations which will be the 75th percentile saturations observed in healthy term newborns.
Other: Titration of oxygen during neonatal resuscitation
Resuscitation will be initiated at 30% O2 and target goal saturations will be the 10th to 25th percentile saturations in OX25 and 75th percentile in OX75 group. The control group will be resuscitated with the OX50 strategy in which resuscitation will be initiated with 30% O2 and target goal saturations will be the approximated median SpO2 observed in healthy term newborns as per current NRP guidelines. For the first 6 minutes after birth, target ranges of of all 3 arms are different. After 6 min, the target ranges are are identical.




Primary Outcome Measures :
  1. Change in Oxidative Balance Ratio from Baseline [ Time Frame: within 2 hours after Birth ]
    Difference in oxidative balance ratio between Cord blood and postnatal sample obtained within 2 hours of life will be assessed.


Secondary Outcome Measures :
  1. Reduction in Isoprostane,Isofluran, 8-OHdG and protein carbonyls [ Time Frame: Within 2 hours after birth and at 24 hours ]
    We will measure other oxidative stress markers such as markers of lipid peroxidation: isoprostanes and Isoflurans, measures of oxidative DNA damage: 8-OHdG and Protein carbonyls to assess global oxidative status of the infants

  2. • Reduction in oxygen load in the delivery room [ Time Frame: During resuscitation in the delivery room for the first 15 minutes of life ]
    Oxygen load will be measured for first 15 minutes of life

  3. Time spent in goal saturations [ Time Frame: During resuscitation in the delivery room ]
    Time spent within goal saturation will be presented as percentage of total time

  4. Incidence of bradycardia during resuscitation [ Time Frame: During resuscitation in the delivery room ]
    Bradycardia defined as HR< 100 bpm

  5. intubation in the delivery room [ Time Frame: During resuscitation in the delivery room ]
    Intubation in the delivery room and reason for intubation will be recorded

  6. Grade III/IV Intraventricular hemorrhage [ Time Frame: within 6 months ]
    Defined by Papile classification

  7. Bronchopulmonary dysplasia (BPD) [ Time Frame: within 6 months ]
    Defined by oxygen requirement at corrected 36 weeks gestation

  8. Necrotizing enterocolitis (NEC) [ Time Frame: within 6 months ]
    Defined by modified bell criteria

  9. Retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), Grade 3/4 intraventricular hemorrhage (IVH), Mortality during NICU stay [ Time Frame: Within 1 year ]
    Defined by operational manual created before the start of the study

  10. Neurodevelopmental Impairment [ Time Frame: Within 2 years ]
    NICHD Neonatal Research Network definition of NDI will be used

  11. Mortality [ Time Frame: within 2 years ]
    Death



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Neonates of obstetric gestational age 23-30 weeks
  2. Inborn at Parkland Hospital, Dallas, Tx
  3. Resuscitation team present to initiate resuscitation

Exclusion Criteria:

  1. Prenatally diagnosed cyanotic congenital heart disease
  2. Prenatally diagnosed congenital diaphragmatic hernia
  3. Prenatally diagnosed significant airway anomaly
  4. Prenatally suspected hypoplasia of lungs
  5. Preductal saturation cannot be measured
  6. Non-viable newborns
  7. Prenatally diagnosed condition due to which decision is made to limit resuscitation in the delivery room by parents and neonatologist.

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): NCT03115463


Locations
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United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75039
Sponsors and Collaborators
University of Texas Southwestern Medical Center
American Academy of Pediatrics
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Vishal Kapadia, MD University of Texas Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03115463    
Other Study ID Numbers: STU 062014-010
1K23HD083511-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
Neonatal Resuscitation
Prematurity
Oxygen