Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

NCT01697904 | Completed

• 1 other identifier: STU 052011-044
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.

Conditions

Prematurity; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Reduction in mean oxidative balance ratio at 1 hour of life

  Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.

  Cord blood and at 1 hour of life

Secondary Outcomes (10)

• Total oxygen load used during active resuscitation

  First 10 minutes of life

• Saturations achieved during first 10 minutes of life

  First 10 minutes of life

• Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation

  First 10 minutes of life

• Time spent with saturation above 94% during active resuscitation

  First 10 minutes of life

• Need for respiratory support in the delivery room

  First 10 minutes of life

Study Arms (2)

Low Oxygen Strategy

EXPERIMENTAL

Resuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR \< 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized. Targeted Pre-ductal SpO2 After birth 1. min 60%-65% 2. min 65%-70% 3. min 70%-75% 4. min 75%-80% 5. min 80%-85% 10 min 85%-94%

Procedure: Titration of oxygen during newborn resuscitation in delivery room

Traditional Oxygen strategy ( TOX)

ACTIVE COMPARATOR

Resuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94%

Procedure: Titration of oxygen during newborn resuscitation in delivery room

Interventions

Titration of oxygen during newborn resuscitation in delivery room PROCEDURE

Low Oxygen Strategy; Traditional Oxygen strategy ( TOX)

Eligibility Criteria

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

You may qualify if:

• Inborn
• Gestation age 24 0/7 to 34 6/7
• Need for active resuscitation

You may not qualify if:

• Prenatally diagnosed cyanotic congenital heart disease
• Non-viable newborns
• Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, United States

Location

Related Publications (1)

• Kapadia VS, Chalak LF, Sparks JE, Allen JR, Savani RC, Wyckoff MH. Resuscitation of preterm neonates with limited versus high oxygen strategy. Pediatrics. 2013 Dec;132(6):e1488-96. doi: 10.1542/peds.2013-0978. Epub 2013 Nov 11.

  PMID: 24218465 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Delivery Rooms

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Vishal S Kapadia, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

• Myra H Wyckoff, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 2, 2012
• Study Start: August 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

US (1)