Balanced Anesthesia for Intubation of Premature Infants

Study Overview
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Brief Summary
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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.

Official Title
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Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study

Conditions
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Premature Birth

Intervention / Treatment
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* Procedure: Tracheal intubation for respiratory care in preterm infants
* Procedure: Tracheal intubation for respiratory care in preterm infants


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Premedication with atropine and morphine | Procedure: Tracheal intubation for respiratory care in preterm infants<br>* Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg<br>|
| Active Comparator: 2<br>Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil | Procedure: Tracheal intubation for respiratory care in preterm infants<br>* Premedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, premedication