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

19. december 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

51

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Parkland Hospital

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 1 time (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Andet: Pulse oximeter and auscultation group
Control
Eksperimentel: Electrocardiogram group
Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.
Andet: Electrocardiogram group
Experimental

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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Sponsor

University of Texas Southwestern Medical Center

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 (Faktiske)

13. juni 2017

Primær færdiggørelse (Faktiske)

23. marts 2018

Studieafslutning (Faktiske)

23. marts 2018

Datoer for studieregistrering

Først indsendt

22. april 2017

Først indsendt, der opfyldte QC-kriterier

25. april 2017

Først opslået (Faktiske)

28. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 092016-048

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