- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01697904
Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Dallas, Texas, Forente stater
- Parkland Memorial Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
10 min 85%-94% |
|
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%
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 uker etter befruktning
|
36 uker etter befruktning
|
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 dødelighet
Tidsramme: 28 dager av livet
|
28 dager av 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Vishal S Kapadia, MD, UT Southwestern
- Hovedetterforsker: Myra H Wyckoff, MD, UT Southwestern
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU 052011-044
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