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Cerebral NIRS Profiles During Premedication for Neonatal Intubation

NCT02700893 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-08-09

No results posted yet for this study

Summary

Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome:

* Cerebral desaturation defined by a rScO2 delta \>20% from the baseline value (before premedication).
* Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.

Conditions

  • Premedication
  • Endotracheal Intubation
  • Cerebral Hypoperfusion

Interventions

DRUG

atropine+ propofol

Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \< 1000g - Renewable once 2.5 mg/kg for infants \> 1000G - Possible additional dose of 1 mg/kg

DRUG

atropine + atracurium + sufentanil

Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \< 1000g 0.2 µg/kg for infants \> 1000g

Sponsors & Collaborators

  • Association Clinique Thérapeutique Infantile du val de Marne

    collaborator OTHER

  • Centre de Recherche Clinique du CHIC

    collaborator UNKNOWN

  • Centre Hospitalier Intercommunal Creteil

    lead OTHER

Principal Investigators

  • Meryl Vedrenne-Cloquet, MD · CHI Créteil

  • Xavier Durrmeyer, MD, PhD · CHI Créteil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700893 on ClinicalTrials.gov