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

NCT ID: NCT01697904

Last Updated: 2012-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Oxygen Strategy

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%

Group Type: EXPERIMENTAL

Titration of oxygen during newborn resuscitation in delivery room

Intervention Type: PROCEDURE

Traditional Oxygen strategy ( TOX)

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%

Group Type: ACTIVE_COMPARATOR

Titration of oxygen during newborn resuscitation in delivery room

Intervention Type: PROCEDURE

Interventions

Titration of oxygen during newborn resuscitation in delivery room

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Vishal Kapadia

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vishal S Kapadia, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Myra H Wyckoff, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

Parkland Memorial Hospital

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24218465 (View on PubMed)

Other Identifiers

STU 052011-044

Identifier Type: -

Identifier Source: org_study_id