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Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates (HEART)

19. desember 2018 oppdatert av: Vishal Kapadia, University of Texas Southwestern Medical Center
The purpose of this study is to determine whether using electrocardiograms (ECGs) during resuscitation of preterm infants (less than 31 weeks gestation) will decrease the amount of time it takes from birth for heart rate (HR) to be above 100 beats per minute and oxygen saturations to be in the goal range, in other words to stabilize the infant. A few studies have been conducted which showed that ECGs are faster at detecting HR than pulse oximetry (PO). Sample sizes, however, have been small and only few extremely low birthweight infants have been included. It is unclear if use of ECG in these tiny preterm infants in addition to traditional techniques to determine HR will be beneficial and impact resuscitation and outcomes. The investigators propose a study where infants will be randomized to either using ECG in addition to PO ± auscultation versus PO ± auscultation only to assess HR during neonatal resuscitation. The investigators hypothesize that the group of infants randomized to ECG will be able to stabilize faster, i.e. achieve HR > 100 beats per minute and oxygen saturation in goal range faster.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

51

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Dallas, Texas, Forente stater, 75235
        • Parkland Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 1 time (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Preterm infants less than <31 weeks gestation born at Parkland hospital vaginally or by C/S
  • Infant with congenital heart disease, congenital anomalies, or chromosomal abnormalities will be included unless comfort care has been agreed upon beforehand
  • Resuscitation team present to attend delivery before birth

Exclusion Criteria:

  • Any infant with prenatally agreed upon comfort care since resuscitation will not be provided
  • Any precipitous delivery since resuscitation team will not be in attendance prior to delivery

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control group
Pulse oximeter and auscultation to determine heart rate during neonatal resuscitation. Pulse oximeter will be used to determine oxygen saturation.
Annen: Pulse oximeter and auscultation group
Control
Eksperimentell: Electrocardiogram group
Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.
Annen: Electrocardiogram group
Experimental

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Infant Stabilization
Tidsramme: During delivery room resuscitation, up to 1 hour
Amount of time it takes from birth for heart rate to be above 100 beats per minute and oxygen saturation to be in the goal range (per Neonatal Resuscitation Program guidelines)
During delivery room resuscitation, up to 1 hour

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to heart rate >100 beats per minute
Tidsramme: During delivery room resuscitation, up to 1 hour
Time in delivery room
During delivery room resuscitation, up to 1 hour
Time to goal oxygen saturation
Tidsramme: During delivery room resuscitation, up to 1 hour
Time in delivery room
During delivery room resuscitation, up to 1 hour
Time of positive pressure ventilation
Tidsramme: During delivery room resuscitation, up to 1 hour
Total time positive pressure received in delivery room
During delivery room resuscitation, up to 1 hour
Incidence of positive pressure ventilation
Tidsramme: During delivery room resuscitation, up to 1 hour
Positive pressure ventilation applied in delivery room
During delivery room resuscitation, up to 1 hour
Incidence of CPR
Tidsramme: During delivery room resuscitation, up to 1 hour
CRP applied in delivery room
During delivery room resuscitation, up to 1 hour
Incidence of intubation
Tidsramme: During delivery room resuscitation, up to 1 hour
Intubation in delivery room
During delivery room resuscitation, up to 1 hour
Maximum FiO2 applied
Tidsramme: During delivery room resuscitation, up to 1 hour
FiO2 applied in delivery room
During delivery room resuscitation, up to 1 hour
Maximum peak inspiratory pressure
Tidsramme: During delivery room resuscitation, up to 1 hour
Maximum peak inspiratory pressure in delivery room
During delivery room resuscitation, up to 1 hour
Incidence of hypothermia
Tidsramme: Until hospital discharge, up to 6 months
Hypothermia on admission to NICU
Until hospital discharge, up to 6 months
Incidence of need for surfactant
Tidsramme: Until hospital discharge, up to 6 months
Surfactant given while in NICU
Until hospital discharge, up to 6 months
Incidence of bronchopulmonary dysplasia
Tidsramme: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of respiratory distress syndrome
Tidsramme: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of pneumothorax
Tidsramme: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of intraventricular hemorrhage
Tidsramme: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of necrotizing enterocolitis
Tidsramme: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of sepsis
Tidsramme: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of symptomatic PDA
Tidsramme: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of appropriate vs inappropriate use of positive pressure ventilation
Tidsramme: During delivery room resuscitation, up to 1 hour
Use in delivery room
During delivery room resuscitation, up to 1 hour
Incidence of equipment failure of pulse oximeter and electrocardiogram
Tidsramme: During delivery room resuscitation, up to 1 hour
Failure in delivery room
During delivery room resuscitation, up to 1 hour

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Texas Southwestern Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. juni 2017

Primær fullføring (Faktiske)

23. mars 2018

Studiet fullført (Faktiske)

23. mars 2018

Datoer for studieregistrering

Først innsendt

22. april 2017

Først innsendt som oppfylte QC-kriteriene

25. april 2017

Først lagt ut (Faktiske)

28. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. desember 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 092016-048

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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