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

1. oktober 2012 opdateret af: Vishal Kapadia, University of Texas Southwestern Medical Center

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater
        • Parkland Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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%
Procedure: Titration of oxygen during newborn resuscitation in delivery room
Aktiv komparator: 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%
Procedure: Titration of oxygen during newborn resuscitation in delivery room

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction in mean oxidative balance ratio at 1 hour of life
Tidsramme: Cord blood and 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

Sekundære resultatmål

Resultatmål
Tidsramme
Total oxygen load used during active resuscitation
Tidsramme: First 10 minutes of life
First 10 minutes of life
Saturations achieved during first 10 minutes of life
Tidsramme: 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
Tidsramme: First 10 minutes of life
First 10 minutes of life
Time spent with saturation above 94% during active resuscitation
Tidsramme: First 10 minutes of life
First 10 minutes of life
Need for respiratory support in the delivery room
Tidsramme: First 10 minutes of life
First 10 minutes of life
Bronkopulmonal dysplasi
Tidsramme: 36 uger efter undfangelsesalderen
36 uger efter undfangelsesalderen
Length of hospitalization
Tidsramme: From date of randomization to date of discharge, expected average of 8 weeks
From date of randomization to date of discharge, expected average of 8 weeks
Retinopathy of Prematurity
Tidsramme: 40 weeks postconceptional age
40 weeks postconceptional age
Neonatal dødelighed
Tidsramme: 28 dage af livet
28 dage af livet
Death before discharge
Tidsramme: From date of randomization to date of discharge, expected average of 8 weeks
From date of randomization to date of discharge, expected average of 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Texas Southwestern Medical Center

Efterforskere

  • Ledende efterforsker: Vishal S Kapadia, MD, UT Southwestern
  • Ledende efterforsker: Myra H Wyckoff, MD, UT Southwestern

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2010

Primær færdiggørelse (Faktiske)

1. januar 2011

Studieafslutning (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

25. september 2012

Først indsendt, der opfyldte QC-kriterier

1. oktober 2012

Først opslået (Skøn)

2. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU 052011-044

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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