Saturation Targets and Resuscitation in Preterm Trial

NCT03115463 | Completed DMC

• 2 other identifiers: STU 062014-0101K23HD083511-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress

Keywords

Neonatal Resuscitation; Prematurity; Oxygen

Outcome Measures

Primary Outcomes (1)

• Change in Oxidative Balance Ratio from Baseline

  Difference in oxidative balance ratio between Cord blood and postnatal sample obtained within 2 hours of life will be assessed.

  within 2 hours after Birth

Secondary Outcomes (11)

• Reduction in Isoprostane,Isofluran, 8-OHdG and protein carbonyls

  Within 2 hours after birth and at 24 hours

• • Reduction in oxygen load in the delivery room

  During resuscitation in the delivery room for the first 15 minutes of life

• Time spent in goal saturations

  During resuscitation in the delivery room

• Incidence of bradycardia during resuscitation

  During resuscitation in the delivery room

• intubation in the delivery room

  During resuscitation in the delivery room

Study Arms (3)

OX25

EXPERIMENTAL

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

OX50

NO INTERVENTION

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

OX75

ACTIVE COMPARATOR

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

Interventions

Titration of oxygen during neonatal resuscitation OTHER

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.

OX25; OX75

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Academy of Pediatrics: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75039, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vishal Kapadia, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 14, 2017
• Study Start: September 20, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2022
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

US (1)