Cerebral NIRS Profiles During Premedication for Neonatal Intubation

NCT02700893 | Completed Phase 2 DMC

• 1 other identifier: PRETTINEO sub-study
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Cerebral desaturation

  rScO2 delta \>20% from the baseline value (before premedication). rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection

  from 1 minute before to 60 minutes after the start of premedication

• FTOE (Fractional Tissue Oxygen Extraction)

  Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection.

  from 1 minute before to 60 minutes after the start of premedication

Study Arms (2)

Atropine + propofol

EXPERIMENTAL

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+ propofol

Atropine + atracurium + sufentanil

ACTIVE COMPARATOR

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

Drug: atropine + atracurium + sufentanil

Interventions

atropine+ propofol DRUG

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

Atropine + propofol

atropine + atracurium + sufentanil DRUG

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

Atropine + atracurium + sufentanil

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Corrected age \< 45 weeks of gestational age
• Currently hospitalized in a neonatal intensive care unit
• Requiring semi-urgent or elective intubation
• Equipped with a reliable and permeable IV line
• Parental consent

You may not qualify if:

• Lack of parental consent
• Parental refusal
• Sedative or anesthetic treatment in the previous 24 hours
• Hemodynamic compromise defined as mean blood pressure\< corrected GA and/or refill time \> 3 seconds
• Upper airway malformation
• Life-threatening situation requiring immediate intubation
• Impossibility to establish venous access
• Any contra-indication to any experimental drug
• Skin lesions or burns of the forehead

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator
• Centre de Recherche Clinique du CHIC: collaborator

Study Sites (2)

Hôpital intercommunal de Créteil

Créteil, 94000, France

Location

Hôpital des enfants

Toulouse, 31059, France

Location

Related Publications (1)

• Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019.

  PMID: 30881948 RESULT

Related Links

• Open access article

MeSH Terms

Interventions

Atropine; Atracurium; Sufentanil

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Meryl Vedrenne-Cloquet, MD

  CHI Créteil

  PRINCIPAL INVESTIGATOR

• Xavier Durrmeyer, MD, PhD

  CHI Créteil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 7, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)