Clinical trial NCT00216944: Balanced Anesthesia for Intubation of Premature Infants
Official title: Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Birth
Keywords: Intubation
premedication
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6-9 months
Secondary outcomes:
measure: Pain score at intubation
timeFrame: 6-9 months
measure: Biochemical stress/pain response
timeFrame: 6-9 months
measure: Physiological stress/pain response
timeFrame: 6-9 months
measure: Behavioural stress/pain response
timeFrame: 6-9 months
measure: Neurophysiological stress/pain response (aEEG)
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Neonatal Departement Lund University Hospital
Study officials:
affiliation: Lund University and Lund University Hospital
name: Vineta Fellman, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norman E, Wikstrom S, Rosen I, Fellman V, Hellstrom-Westas L. Premedication for intubation with morphine causes prolonged depression of electrocortical background activity in preterm infants. Pediatr Res. 2013 Jan;73(1):87-94. doi: 10.1038/pr.2012.153. Epub 2012 Nov 5.
citation: Norman E, Wikstrom S, Hellstrom-Westas L, Turpeinen U, Hamalainen E, Fellman V. Rapid sequence induction is superior to morphine for intubation of preterm infants: a randomized controlled trial. J Pediatr. 2011 Dec;159(6):893-9.e1. doi: 10.1016/j.jpeds.2011.06.003. Epub 2011 Jul 27.