Balanced Anesthesia for Intubation of Premature Infants

Phase 4

Completed

• Conditions: Premature Birth
• Interventions: Procedure: Tracheal intubation for respiratory care in preterm infants

• Registration Number: NCT00216944
• Lead Sponsor: Lund University Hospital

Brief Summary

The study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. In addition a pain scale for prolonged stress/pain for premature neonates in NICU-care will be validated, and the individual pharmacogenetic profile in relation to the need of morphine after the intubation will be investigated. The hypothesis is that balanced anesthesia before intubation facilitates the procedure, decreases the amount of stress and pain related to it, and causes a decreased need for analgesia after the intubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-22
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2010-02-12
• Last Update Posted: 2010-02-15
• Status Verified: 2010-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• <37 gw at birth
• <72 hours postnatal age, not previously intubated and no analgetics or sedatives the last 12 hours or >72 hours postnatal age, primary or reintubation
• Informed consent from parents

Exclusion Criteria

• Intubation directly postnatally at the delivery room
• Asphyxia (apgar <4 at 10 min, Umb-pH <7,0
• S-Potassium > 6,5
• Major malformations
• Postsurgery intubation
• Included in an other intervention study first week in life
• Other intervention study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tracheal intubation for respiratory care in preterm infants	Premedication with atropine and morphine
2	Tracheal intubation for respiratory care in preterm infants	Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil

Primary Outcome Measures

Name	Time	Method
Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation	6-9 months

Secondary Outcome Measures

Name	Time	Method
Pain score at intubation	6-9 months
Biochemical stress/pain response	6-9 months
Physiological stress/pain response	6-9 months
Behavioural stress/pain response	6-9 months
Neurophysiological stress/pain response (aEEG)	6-9 months

Trial Locations

Locations (1)

Neonatal Departement Lund University Hospital; 🇸🇪 Lund, Sweden