Cerebral NIRS Profiles During Premedication for Neonatal Intubation

• Sponsor: Centre Hospitalier Intercommunal Creteil (Other)
• Overall Status: Completed
• CT.gov ID: NCT02700893
• Collaborator: Association Clinique Thérapeutique Infantile du val de Marne (Other), Centre de Recherche Clinique du CHIC (Other)
• Enrollment: 28
• Locations: 2
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site: 14
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premedication; Endotracheal Intubation; Cerebral Hypoperfusion	Drug: atropine+ propofol; Drug: atropine + atracurium + sufentanil	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cerebral NIRS Profiles During Premedication for Neonatal Intubation
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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+ 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
Active Comparator: 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	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

Outcome Measures

Primary Outcome Measures

1. Cerebral desaturation [from 1 minute before to 60 minutes after the start of premedication]

   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

2. FTOE (Fractional Tissue Oxygen Extraction) [from 1 minute before to 60 minutes after the start of premedication]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 28 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Inclusion in another trial not permitting any other participation

• Impossibility to establish venous access

• Any contra-indication to any experimental drug

• Skin lesions or burns of the forehead

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital intercommunal de Créteil	Créteil		France	94000
2	Hôpital des enfants	Toulouse		France	31059

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Meryl Vedrenne-Cloquet, MD, CHI Créteil
• Study Director: Xavier Durrmeyer, MD, PhD, CHI Créteil

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Open access article

Publications

None provided.

• Responsible Party: Xavier Durrmeyer, MD, PhD, Centre Hospitalier Intercommunal Creteil
• ClinicalTrials.gov Identifier: NCT02700893
• Other Study ID Numbers: PRETTINEO sub-study
• First Posted: Mar 7, 2016
• Last Update Posted: Aug 9, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Atropine; Sufentanil; Propofol; Atracurium

Study Results

No Results Posted as of Aug 9, 2019