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

19 december 2018 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

51

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 1 timme (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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.
Övrig: Pulse oximeter and auscultation group
Control
Experimentell: Electrocardiogram group
Electrocardiogram to determine heart rate during neonatal resuscitation. Pulse oximeter will still be used per Neonatal Resuscitation Program guidelines for oxygen saturation.
Övrig: Electrocardiogram group
Experimental

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Infant Stabilization
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to heart rate >100 beats per minute
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: During delivery room resuscitation, up to 1 hour
CRP applied in delivery room
During delivery room resuscitation, up to 1 hour
Incidence of intubation
Tidsram: During delivery room resuscitation, up to 1 hour
Intubation in delivery room
During delivery room resuscitation, up to 1 hour
Maximum FiO2 applied
Tidsram: 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
Tidsram: 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
Tidsram: Until hospital discharge, up to 6 months
Hypothermia on admission to NICU
Until hospital discharge, up to 6 months
Incidence of need for surfactant
Tidsram: Until hospital discharge, up to 6 months
Surfactant given while in NICU
Until hospital discharge, up to 6 months
Incidence of bronchopulmonary dysplasia
Tidsram: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of respiratory distress syndrome
Tidsram: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of pneumothorax
Tidsram: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of intraventricular hemorrhage
Tidsram: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of necrotizing enterocolitis
Tidsram: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of sepsis
Tidsram: Until hospital discharge, up to 6 months
Incidence in NICU
Until hospital discharge, up to 6 months
Incidence of symptomatic PDA
Tidsram: 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
Tidsram: 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
Tidsram: During delivery room resuscitation, up to 1 hour
Failure in delivery room
During delivery room resuscitation, up to 1 hour

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Texas Southwestern Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 juni 2017

Primärt slutförande (Faktisk)

23 mars 2018

Avslutad studie (Faktisk)

23 mars 2018

Studieregistreringsdatum

Först inskickad

22 april 2017

Först inskickad som uppfyllde QC-kriterierna

25 april 2017

Första postat (Faktisk)

28 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 december 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 december 2018

Senast verifierad

1 december 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 092016-048

Plan för individuella deltagardata (IPD)

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Nej

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