Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Endotracheal Intubation Clinical Trial

Official title:

Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700893
• Other study ID #: PRETTINEO sub-study
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2019
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hypoperfusion
• Endotracheal Intubation
• Premedication

Intervention

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
• 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

Locations

Country	Name	City	State
France	Hôpital intercommunal de Créteil	Créteil
France	Hôpital des enfants	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Centre de Recherche Clinique du CHIC, Clinical and Therapeutic Association of Val de Marne: ACTIV

Country where clinical trial is conducted

France, 

References & 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. eCollec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Open access article